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Results suggest broader applications for DehydraTECH-CBD beyond hypertension

KELOWNA, BC / December 8, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to issue follow-up results from human clinical study HYPER-H21-2 confirming that DehydraTECHTM-processed cannabidiol ("CBD") reduces arterial stiffness, potentially broadening its application to treatment of cardiovascular and other disease states beyond hypertension where it has already shown tremendous promise.

"Reducing arterial stiffness in Lexaria's recent hypertension study after only a single day of dosing with our DehydraTECH-CBD is a major discovery," said John Docherty, President of Lexaria. "We know that increased arterial stiffness is correlated with many serious and life-threatening diseases affecting people worldwide, and we are optimistic that our latest findings could have future widespread implications for promotion of improved human health and wellness."

Arterial stiffness is a strong predictor of many aspects of human disease. The impacts of increased arterial stiffness are not limited only to coronary heart disease such as hypertension, but also include other disease states such as diabetes mellitus, renal disease and more. It can also be a prognostic marker for cardiovascular events and all-cause mortality, even in asymptomatic individuals without overt cardiovascular disease.

The efficacy of blood pressure treatment and differences in efficacy between different types of antihypertensive agents is strongly correlated with measuring arterial stiffness, whereby the significant blood pressure reduction effects as previously reported with DehydraTECH-CBD from study HYPER-H21-2 appear to have been at least partially due to these improvements in arterial stiffness.

The arterial stiffness findings from study HYPER-H21-2 are summarized in the table below. Arterial stiffness was measured through pulse wave velocity ("PWV") evaluation, together with assessments of augmentation index and pressure. All comparisons between DehydraTECH-CBD and placebo were statistically significant (p < 0.01).

DehydraTECH-CBD

Placebo

Pulse Wave Velocity (PWV)

8.1 ± 0.3 m/s

8.3 ± 0.3 m/s

Augmentation Index (Alx)

28.4 ± 1.4%

32.3 ± 1.3%

Augmentation Index corrected to heart rate of 75 BPM (Alx.75)

27.8 ± 1.3%

30.4 ± 1.3%

Augmentation Pressure (AugP)

12.0 ± 1.0 mmHg

14.6 ± 1.0 mmHg

In the table above, smaller numbers are the objective. PWV values normally increase by 0.9 m/s every 10 years between the age of 45 and 60 as arterial stiffness increases with aging. It has been estimated that a 1.0 m/s increase in PWV accounts for a 15% increase in cardiovascular and all-case mortality.

To have decreased arterial stiffness to the degree demonstrated in our present study after only a single day of dosing with DehydraTECH-CBD is quite remarkable and will be more thoroughly investigated in Lexaria's upcoming 6-week hypertension study HYPER-H21-4, where multiple doses over this period are expected to demonstrate additional benefits against hypertension and arterial stiffness.

As first reported on September 7, 2021, at selected times during study HYPER-H21-2, some volunteers with mild to moderate hypertension had reductions of as much as a 20 mmHg (i.e., 23%) drop in blood pressure relative to placebo. When averaged over the 24-hour duration of the study, reductions in diastolic, systolic and mean arterial pressure were all significantly evidenced with DehydraTECH-CBD when compared to the placebo condition. All secondary objectives of human clinical study HYPER-H21-2 have now been successfully completed

About DehydraTECH-CBD

DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure.

About Human Study HYPER-H21-2

Human Study HYPER-H21-2 was conducted at a European medical research hospital. Sixteen human volunteers (8 male; 8 female) aged 45-65 with otherwise untreated pre- or mild-hypertension were given either a placebo, or three separate doses of 150 mg each of DehydraTECH-CBD over a 14-hour period and studied over a 24-hour duration. The average weight and height were 91 ± 13 kg and 173 ± 9 cm. Ambulatory blood pressure was recorded for 24 hours.

Hypertension Markets

The hypertension market is valued at $28 billion per year and is expected to continue growing as one of the world's top health problems. Geographically, some of the highest rates of growth are expected in more recently industrialized nations such as China and India. Over 1.1 billion people worldwide suffer from hypertension - elevated blood pressure. Hypertension is a major risk factor for cardiovascular and cerebrovascular disease, and accounts for approximately 45% of cardiovascular disease mortality and morbidity worldwide.

Drugs focused on blood pressure and related conditions are some of the highest selling drugs in the world. Lipitor, used to treat high cholesterol and reduce the risk of heart disease, has generated $94.7 billion in revenue from 1992 until 2017. Plavix, used to prevent heart attack and stroke, has sold $46.5 billion from 1992 until 2017. There are several hypertension drugs that each generate $1 billion per year or more in revenue.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 23 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



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https://www.accesswire.com/676498/Lexarias-DehydraTECHTM-CBD-Reduces-Arterial-Stiffness-Results-Confirmed-in-Human-Clinical-Study-HYPER-H21-2

KELOWNA, BC / November 10, 2021 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces its plans for several new and ongoing DehydraTECHTM applied R&D programs for 2022. The studies mentioned herein are only a fraction of Lexaria's 2022 work programs.

"Calendar 2022 will continue to see significant milestones in utilizing DehydraTECH-CBD for investigation of heart disease and hypertension; and separately, for oral nicotine delivery as an alternative to smoking", said Chris Bunka, CEO of Lexaria Bioscience Corp. "We are delighted to announce that DehydraTECH as an enhanced drug delivery platform will also be evaluated for characteristics and potential treatment options for hormone replacement, dementia, rheumatoid disease and diabetes."

Heart disease is the #1 killer in the US, responsible for the deaths of 659,000 Americans each year; and cigarette smoking is the #3 killer in the US, responsible for the deaths of 480,000 Americans per year. Lexaria continues its unwavering commitment to lessening the loss of life in these areas and will detail these advanced work programs in the heart disease and nicotine sectors in separate communications.

During 2022, Lexaria will also be conducting pharmacokinetic ("PK") and efficacy modelling studies in animals to evaluate DehydraTECH's ability to improve the delivery characteristics of many other drugs or active pharmaceutical ingredients ("APIs") and determine whether there might be commercial benefit to continue with further pursuit within different market sectors. The following studies are part of approximately 12 applied R&D programs planned for 2022 (tentative start dates are included):

HOR-A22-1: April, 2022. This PK study will evaluate the ability of DehydraTECH to enhance the delivery characteristics of estrogen. Estrogen helps to control the menstrual cycle but also controls cholesterol and protects bone health. The hormone replacement market is estimated at $46.5 billion in 2027.

DEM-A22-1: July, 2022. This efficacy study will evaluate DehydraTECH-CBD with and without nicotine for the potential treatment of dementia. Alzheimer's disease is the most common form of dementia and accounts for at least 60% of all cases, and nicotine is already showing promising results related to Alzheimer's treatment. An estimated 55 million people worldwide are currently affected by dementia, with 78 million expected to be living with some form of dementia by 2030. The dementia drug treatment market is estimated at $19.6 billion in 2026.

RHEUM-A22-1: October, 2022. This efficacy study will focus on the ability of DehydraTECH-CBD to potentially affect treatment of rheumatoid disease. Given CBD's postulated efficacy related to inflammation, Lexaria will explore a possible role for CBD in this area of investigation. Rheumatic diseases are autoimmune and inflammatory diseases that cause the immune system to attack joints, bones, muscles and organs. There are over 100 rheumatic diseases including Fibromyalgia, Lupus, Osteoarthritis, Rheumatoid Arthritis and more. The Rheumatoid Arthritis therapeutics market alone is expected to be over $30 billion per year by 2025.

DIAB-A22-1: November, 2022. This efficacy study will explore the ability of DehydraTECH-CBD to potentially affect treatment of diabetes. Diabetes prevents the body from making enough insulin, resulting in abnormal blood sugar levels. Diabetes is the 7th largest cause of death in the US and there is currently no cure. Investigation of CBD related to diabetes is in early stages, though there are some areas of ongoing investigation. CBD has shown some ability to reduce the incidence of diabetes in mice. The prescription drug market used to treat diabetes is expected to be a $77.9 billion global market in 2024.

Lexaria raised approximately USD$15 million in funding during 2021 which has enabled the active work programs of 2021 and supported significant advances in the fields of heart disease, oral nicotine, and antiviral research. Lexaria's budget for applied R&D during 2022 is fully funded and includes each of the R&D programs noted within this press release. Lexaria's objective for its R&D programs is to build significant value for all Lexaria stakeholders while pursuing policies for significant improvements to human health.

Lexaria is debt free and expects its current cash reserves to meet all its needs until at least Q2, 2023. Lexaria plans to seek strategic corporate business partners for many of its specific drug investigations after sufficient data has been generated which, if successful, could generate any combination of up-front, milestone, and/or royalty payments to Lexaria.

In other news, Lexaria has engaged Barretto Pacific Corporation to provide various investor relations related services for compensation of USD$56,000 for the first four months, and USD$12,000 per month thereafter for the remainder of the 1-year term. Lexaria has also retained the consulting services of Mei Kuo for a 3-month period ending January 08, 2022, for public relations, marketing and similar related services in return for payment of USD$15,000 per month. No stock or options have or will be issued in relation to either contract.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 23 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays, alterations or cancellations of planned R&D that could occur related to pandemics or for other reasons including changed priorities or lack of funding, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



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https://www.accesswire.com/672071/Lexaria-2022-RD-Programs-to-Include-Investigations-into-Alzheimers-Disease-and-Diabetes

  • DehydraTECH-CBD also being evaluated in three other human clinical studies
  • Positive studies would support Lexaria's regulatory approval plans

KELOWNA, BC / November 3, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces a significant new study to expand its hypertension clinical program and provides updates on three ongoing human clinical studies evaluating its proprietary DehydraTECH-CBD for potentially treating hypertension and heart disease.

"HYPER-H21-4 is the most ambitious study Lexaria has ever undertaken and is enabled from the successful outcomes from our other 2021 human hypertension studies," said Chris Bunka, CEO of Lexaria Bioscience Corp. "Outcomes from this study could support Lexaria's goals related to pursuit of regulatory approvals for DehydraTECH-CBD for potential use as a treatment for high blood pressure."

HYPER-H21-4

HYPER-H21-4 is expected to consist of 60 volunteers between the ages of 45-70 using three 150 mg doses of DehydraTECH-CBD, every day for the 6-week duration of the study. The study will use a double blinded, randomized cross-over design, and utilize a placebo control. Some volunteers will already be using leading standard of care hypertension drugs such as ACE inhibitors with or without diuretics to help evaluate the efficacy of DehydraTECH CBD with and without other hypertension treatments. The extended duration of the study will allow Lexaria to gather critical data monitoring extended use of DehydraTECH-CBD and will evaluate the potential for longer term health benefits. Study protocols are being readied for submission to the Independent Review Board ("IRB") and approval is anticipated by January, 2022.

HYPER-H21-4 is more comprehensive than any work previously undertaken by Lexaria and many types of analysis will be performed including 24-hour ambulatory blood pressure (which is the primary outcome); arterial stiffness and autonomic balance; brain structure and function through brain magnetic resonance imaging ("MRI"); blood biomarkers (including lipids such as cholesterol and more); renal, hepatic, sleep quality / daytime sleepiness / sleep disorders; actigraphy, geriatric depression scale, perceived stress, and Beck anxiety inventory. The wide range of data collection could provide additional insights into the benefits of DehydraTECH-CBD that might otherwise remain hidden from view.

HYPER-H21-4 is expected to produce an enormous amount of data that, if positive, should be supportive of Lexaria's plans to enter regulatory pathways anticipated to result in eventual regulatory approval to use DehydraTECH-CBD to treat hypertension and perhaps other forms of cardiovascular disease. This study is entirely funded through the Company's existing cash resources and is not subject to any financing requirement.

Updates on Other Hypertension Studies

HYPER-H21-1

Partial results, related only to BP readings, were released on July 29, 2021, as summarized below. This study was conducted in 24 adult volunteers, used a single dose of 300 mg of DehydraTECH-CBD, and measured results over a number of hours. Pending analyses and results include speed and rate of absorption of the CBD and its main metabolites, as well as evaluation of inflammatory markers associated with cardiovascular disease and gold-standard biomarkers of nitric oxide. This latter measure is expected to provide mechanistic insight into the witnessed reduction in blood pressure via vasodilation. Those results were originally expected to be released by October, but are now due by early December due to certain supply chain challenges.

BP reduction from baseline was greatest when measured via systolic pressure. In the subset of volunteers who were Stage 2 hypertensive, peak systolic BP reductions from baseline were observed of as much as approximately 13 mmHg by the 50-minute time point with DehydraTECH-CBD, and systolic BP remained depressed throughout almost the entire 3-hour duration of the study. For reference, other studies of coronary heart disease ("CHD") have concluded that "lowering systolic pressure by 10 mm Hg or diastolic pressure by 5 mm Hg using any of the main classes of drugs reduced CHD events (fatal and nonfatal) by about a quarter and stroke by about a third, regardless of the presence or absence of vascular disease and of pretreatment BP. Heart failure is also reduced by about 25%."

HYPER-H21-2

Partial results were released on September 7, 2021 as summarized below. This study was conducted in 16 adult volunteers, used three doses of 150 mg each of DehydraTECH-CBD, and measured results over a 24-hour ambulatory time-period. Pending analyses and results to be concluded include additional blood pressure subset analyses, sleep quality and other data analyses that are in progress and final results are expected in early December.

At selected times during the 24-hour study, volunteers with mild to moderate hypertension averaged as much as a 20 mmHg (i.e., 23%) decrease in BP relative to placebo. Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 7.0% (p < 0.001) in systolic pressure with DehydraTECH-CBD relative to placebo.

HYPER-H21-3

DehydraTECH-CBD manufacturing for this study is complete and the clinical test articles have been delivered to the study location where dosing is expected to begin in mid-November or thereabouts, and dosing is expected to be complete by mid-December. Thereafter, the BP findings are expected to be reportable by the end of January, 2022.

HYPER-H21-3 will be conducted in 16 adult volunteers and will utilize a single dose of 300mg of DehydraTECH-CBD. This study is designed to evaluate acute pulmonary hypertension and cardiovascular effects under severe stress. Exposure to acute reductions in oxygen tension (i.e., hypoxia) causes rapid hypoxic pulmonary vasoconstriction ("HPV") and, as a consequence of this HPV response, pulmonary arterial pressure increases. If this increase in pressure becomes too high, as is the case in many cardiac pathologies, an excess of fluid in the lungs can occur that causes difficulty with breathing. The extent to which DehydraTECH-CBD may act as a novel treatment for HPV, and potentially as an alternative treatment for pulmonary hypertension, is unknown. Thus, the primary objective of this study is to evaluate the effect of DehydraTECH-CBD on pulmonary vascular function in normotensive individuals exposed to hypoxia. The magnitude of HPV, blood pressure, heart rate, blood samples, and pulmonary gas exchange data will be collected and analyzed.

Hypertension and Cardiovascular Disease Markets

About 1.28 billion people worldwide suffer from hypertension - elevated blood pressure-in a market valued at $28 billion per year and is recognized as one of the world's top health problems. Only 21% of people with hypertension have it under control which demonstrates enormous unmet need. Hypertension is one subset of the broader cardiovascular disease category, which is expected to be a $146 billion market in 2022.

"Among persons 50 years of age or older, isolated systolic hypertension is the most common form of hypertension, and systolic blood pressure becomes more important than diastolic blood pressure as an independent risk predictor for coronary events, stroke, heart failure, and end-stage renal disease ("ESRD"). The Global Burden of Disease Study identified elevated blood pressure as the leading risk factor, among 67 studied, for death and disability-adjusted life-years lost during 2010."

Drugs focused on blood pressure and related conditions are some of the best selling drugs in the world. Lipitor, used to treat high cholesterol and reduce the risk of heart disease, has generated $94.7 billion in revenue from 1992 until 2017. Plavix is used to prevent heart attack and stroke, has sold $46.5 billion from 1992 until 2017. There are several hypertension drugs that each generate $1 billion per year or more in revenue.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 23 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/670912/Lexaria-Announces-Ambitious-New-Hypertension-Study-HYPER-H21-4

  • New study EPIL-A21-1 will compare effectiveness of FDA-approved Epidiolex to DehydraTECHTM-CBD for reducing seizure activity

KELOWNA, BC / November 1, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, has commenced an important new study exploring whether DehydraTECHTM-CBD evidences superior ability to inhibit seizure activity compared to both generic cannabidiol ("CBD") and Epidiolex.

Epidiolex is the first and only FDA-approved CBD medication for the treatment of seizures associated with two rare and severe forms of paediatric epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

Experts in respirology and neurobiology are among the talented team assembled to conduct the study which is designed to investigate if DehydraTECH-CBD has similar or superior levels of efficacy in treating seizures as does the world's only CBD-based seizure medication, Epidiolex. Lexaria's seizure program has been developed due to the significant gains in systemic delivery and brain uptake that Lexaria has repeatedly evidenced and announced from other studies comparing DehydraTECH-CBD with concentration-matched controls, which it believes has potential to improve therapeutic efficacy for a range of disease conditions affecting the central nervous system including epilepsy.

Epidiolex was developed by GW Pharmaceuticals plc ("GW") and is now sold by Jazz Pharmaceuticals ("Jazz") subsequent to the 2021 US$7.2 billion takeover of GW by Jazz.

Animal study EPIL-A21-1 has entered early-stage preparatory work and results are expected by Q3 2022. This animal study is being conducted by a leading US-based independent laboratory using advanced DehydraTECH 2.0 formulations and is fully funded through existing Lexaria resources.

In other developments, Lexaria is pleased to report its first patent award for DehydraTECH in Mexico. The patent award protects Lexaria's proprietary DehydraTECH for use with cannabinoids and nicotine. The Company has also been awarded another patent in Japan for the use of DehydraTECH utilizing non-psychoactive cannabinoids, nicotine, vitamins, or non-steroidal anti-inflammatory ("NSAID") substances. This latest patent award in Japan becomes Lexaria's 5th patent awarded in 2021. Lexaria's patented DehydraTECH currently benefits from 23 granted patents in the countries of the USA, Australia, the European Union, India, Japan, and Mexico. Lexaria continues to build its intellectual property portfolio in these and other countries.

About Epidiolex

Epidiolex is an FDA-approved prescription CBD available in an oral solution to treat Lennox-Gastaut syndrome and Dravet syndrome in children two years of age and older. Epidiolex's effectiveness was studied in three randomized clinical trials involving a total of 516 patients and was shown to be effective in reducing the frequency of seizures when compared to placebo. In September 2019, Epidiolex was approved for use in all 27 member countries of the European Union.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 23 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/670466/Lexaria-Announces-RD-Program-to-Compare-First-and-Only-FDA-Approved-Prescription-Cannabidiol

  • DehydraTECH delivers equivalent quantity of oral THC three times faster: 15 minutes vs. 45 minutes

KELOWNA, BC / October 13, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that its recent oral tetrahydrocannabinol ("THC") absorption study THC-A21-1 revealed that DehydraTECHTM-THC delivered via oral ingestion required only 15 minutes to deliver THC levels in blood plasma comparable to levels achieved at 45 minutes with concentration-matched controls.

During the study DehydraTECH-THC delivered more THC into bloodstream than the industry standard medium chain triglyceride ("MCT" or "coconut oil") based control formulation from the 2-minute mark onwards, then dropped rapidly to the same level as the MCT control by the 6-hour mark.

According to Harvard Medical School, the most common use for medical cannabis in the US is for the control of pain. Chronic pain is associated with nerve disorders and multiple sclerosis, and users are frequently cited as responding to a cannabis treatment program, without the highly addictive or sedating effects of opiates. Lexaria's investigation of enhanced delivery characteristics of THC utilizing DehydraTECH technology is focused on medical applications.

Key pharmacokinetic ("PK") findings from the study are tabulated below demonstrating statistically significant improvements in peak and total THC delivery (i.e., maximum concentration or Cmax and total area under the curve up to the point of the last measurement or AUClast respectively):

DehydraTECH-THC Cmax* % Improvement

(ng/mL)

MCT Control THC

(ng/mL)

DehydraTECH-THCAUClast** % Improvement

(hr ng/mL)

MCT (Coconut Oil) Control THC

(hr ng/mL)

178.6 ± 81.1

110.9%

(p=0.026)

84.7 ± 43.9

539.2 ± 190.9

96.5%

(p=0.013)

274.4 ± 106.9

"The cannabis industry continues to use outdated formulations and processes that ignore the needs of modern THC users," said Chris Bunka, CEO of Lexaria Bioscience Corp. "THC users today include recreational, medicinal and pharmaceutical users, all of whom need technology that doesn't rely on harmful delivery methods such as smoking but still provides rapid onset and high bioavailability which common oral formats do not offer. Our study findings demonstrated rapid delivery, increased overall THC delivery, and higher brain tissue delivery; all of which is consistent with the wants and needs of THC customers."

DehydraTECH processing continues to prove its ability to deliver drugs more effectively not just into the bloodstream, but also into brain tissue. Only two time-points were selected to collect brain tissue absorption samples, meaning blood concentration levels likely had peaked much earlier, but DehydraTECH-THC brain tissue levels were effectively twice as high as the MCT controls, mirroring what was seen with the blood level readings achieved during the study:

Brain Absorption

DehydraTECH THC Improvement %

(ng/g)

Coconut-Oil Control THC

(ng/g)

8-Hours

121.0 ± 92.6

103.0%

59.6 ± 20.5

24-Hours

14.4 ± 10.3

108.7%

6.9 ± 5.2

About Study THC-A21-1

Study THC-A21-1 was performed by a leading, independent testing laboratory. Blood samples for 20 male Sprague Dawley rats (two groups of 10) are represented in the graph above taken at intervals of 2, 4, 6, 8, 12, 15, 30, 45, and 60 minutes, and at 2, 4 and 6 hours. Brain tissues were collected at 8 and 24 hours.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 21 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



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  • DehydraTECH-oral nicotine delivery peaked in bloodstream 10x to 20x faster than controls
  • Peak levels achieved were up to 10x higher than controls

KELOWNA, BC / October 5, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that its recent oral nicotine absorption study NIC-A21-1 revealed that DehydraTECHTM-nicotine delivered via the oral pouch product format required only 2 to 4 minutes to deliver nicotine levels in blood plasma comparable to levels achieved at 45 minutes with concentration-matched controls.

DehydraTECH-nicotine also reached statistically significant peak blood plasma levels up to 10-fold higher overall than controls (p=0.004) while still clearing from blood virtually as quickly as the controls. Lexaria believes that these findings support the world's fastest-acting nicotine oral mucosal absorption, offering a safer nicotine alternative for the world's 1.1 billion smokers to kick the antiquated habit. The study utilized Lexaria's recently developed, advanced "DehydraTECH 2.0" nicotine formulations and was conducted by a leading, independent testing laboratory in the United States.

Lexaria's DehydraTECH technology does not function with cigarettes or with vape devices, two outdated nicotine delivery methods that cause unnecessary harm. DehydraTECH is instead focused on assisting the world's smokers and vapers to select less harmful nicotine dosing methods via the oral mucosal absorption route, thereby reducing the carnage caused by smoking.

In the study, the generic nicotine benzoate pouch required approximately 45 minutes to reach its peak delivery rate whereas the DehydraTECH nicotine benzoate pouch reached peak delivery rates at both 8 minutes and again at 30 minutes. In fact, just 4 minutes after the pouch was placed in the mouth, the DehydraTECH-nicotine had reached a higher delivery level than the generic achieved at any point during the study.

DehydraTECH vs. Control NICBZ Formulations Nicotine Plasma Levels (ng/mL)

Similarly, the generic nicotine polacrilex pouch also required approximately 45 minutes to reach its very subdued peak delivery rate while the DehydraTECH nicotine polacrilex pouch achieved a comparable level in just 2 minutes. The DehydraTECH nicotine polacrilex pouch delivered over 10 times the nicotine level in blood plasma at peak than the generic version.

DehydraTECH vs. Control NICPX Formulations Nicotine Plasma Levels (ng/mL)

Key pharmacokinetic findings from the study are tabulated below demonstrating statistically significant improvements in peak and total nicotine delivery (i.e., maximum concentration or Cmax* and total area under the curve up to the point of the last measurement or AUClast** respectively):

Nicotine Type

DehydraTECH Cmax* % Improvement

(ng/mL)

Control

(ng/mL)

DehydraTECH

AUClast** % Improvement

(hr ng/mL)

Control

(hr ng/mL)

Nicotine Benzoate

367.3 ± 220.2

263%

(p=0.002)

101.1 ± 39.0

227.6 ± 86.2

169%

(p=0.0003)

84.7 ± 13.5

Nicotine Polacrilex

344.6 ± 286.7

1052%

(p=0.004)

29.9 ± 15.8

179.3 ± 73.6

664%

(p=0.00004)

23.5 ± 8.7

"We are extremely pleased with the performance of our latest DehydraTECH-2.0 nicotine oral pouch formulations in this study," said Chris Bunka, CEO of Lexaria. "Our technology was ten to twenty times faster in delivering comparable levels of nicotine into bloodstream than the peak of the concentration-matched controls and went on to far exceed their total delivery, which should provide much greater consumer satisfaction. Performance gains of this magnitude could be of great significance in enabling the oral pouch product category to offer improved nicotine satiety and effectiveness, with a goal of one day rendering pulmonary administration practices like smoking and vaping as obsolete."

As a result of the outstanding performance in this nicotine oral mucosal absorption study in animals, Lexaria plans to progress to a larger investigation in human volunteers to compare its DehydraTECH-nicotine pouch performance to that of existing leading brands such as products including Zyn (Swedish Match) and ON! (Altria). Lexaria is currently in the design phase of this proposed human clinical study, which will be independently funded with existing capital. The Company will announce further details as they become available. Lexaria is optimistic that this larger human study will produce positive findings pursuant to those evidenced in its previous 2021 subjective human testing that utilized DehydraTECH-nicotine formulations demonstrating onset of initial nicotine effectiveness in as little as 1.5 to 4 minutes after an oral dose. These results are aligned with the current dog study and compared to an average of 8 to 10 minutes for onset of initial nicotine effectiveness with selected industry products Lexaria previously evaluated.

The global nicotine oral pouch market is among the fastest growing nicotine sectors in the world, with revenues estimated at $2.3 billion in 2020, forecasted to grow to $21.8 billion by 2027. Lexaria believes DehydraTECH is ideally suited for the oral nicotine pouch sector, and that this product format, if empowered with DehydraTECH for rapid and more complete nicotine delivery, could revolutionize the nicotine industry as the first practical, reduced risk category to successfully challenge smoking tobacco. In October 2019, the Food and Drug Administration for the first time ever, authorized reduced risk claims for certain nicotine oral pouches stating that these products "put you at lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis," compared to cigarettes.

The global tobacco market represents the total revenue generated by all smokers, vapers, and users of all forms of tobacco and nicotine in commercial use today, and is an $818 billion market. Historically, alternative nicotine products have failed to deliver consumer satisfaction to a sufficient degree to replace smoking, in part because of the slowness with which the nicotine enters the bloodstream. In a nicotine industry traditionally slow to innovate, Lexaria believes that its fast-acting DehydraTECH oral nicotine could enable development of the best non-combusted oral nicotine product format to deliver that satisfaction.

Cigarette smoking is one of the world's biggest preventable health hazards, killing 8 million people per year. Lexaria is focused on oral nicotine products that do not contain tobacco in its leaf form. By comparison, Lexaria regards so-called "heat-not-burn" products and vape devices to be inferior intermediate nicotine formats from the perspective of achieving less harmful outcomes.

About DehydraTECH-Nicotine
DehydraTECH-nicotine is a unique nicotine formulation Lexaria has developed and is optimizing, using tobacco-derived nicotine benzoate or nicotine polacrilex raw materials, based on its patented and proprietary DehydraTECH drug delivery technology. Fast-acting DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral administration. DehydraTECH has also previously demonstrated enhanced delivery of nicotine into brain tissue, which is of particular importance for improved effectiveness and satisfaction.

The DehydraTECH-nicotine formulations used in the study described herein were based upon Lexaria's latest "DehydraTECH-2.0" advancements and were tested with average potencies of 3.1 mg to 3.3 mg mg of nicotine per pouch for the DehydraTECH nicotine benzoate pouches, and between 3.5 mg to 3.8 mg of nicotine per pouch for the DehydraTECH nicotine polacrilex pouches. The concentration-matched non-DehydraTECH control pouches used in the study were tested with average potencies of 3.1 mg and 3.5 mg of nicotine per pouch respectively.

About Study NIC-A21-1
Study NIC-A21-1 was performed by a leading, independent testing laboratory in 40 anesthetized male beagle dogs weighing roughly 8-14 Kg each. The dogs were divided into four groups of ten, and each had one of the four study test article nicotine pouches placed in their buccal space while laying on their side for a 30-minute duration. The pouches were uniformly squeezed gently every five minutes over this period and care was taken to ensure that saliva did not escape their mouths through the entire two-hour duration of the study observation period. Blood samples were taken at intervals of 0, 2, 4, 6, 8, 10, 15, 30, 45, 60 and 120 minutes. All dogs were well treated, tolerated the pouches well and returned to full health following conclusion of the study.

About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 21 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. All recreational nicotine products pose risks to users and should be avoided if possible. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



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KELOWNA, BC / September 9, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces today that Chairman & CEO Chris Bunka will present at the 23rd Annual H.C. Wainwright Global Investment Conference which is being held virtually from September 13-15, 2021.

Mr. Bunka will provide an overview of the Company's latest news and updates which will become available beginning on September 13th at 7:00 AM ET.

For more information and to register for the event, please visit the conference website: hcwevents.com/annualconference.

A copy of the presentation can also be found on Lexaria's website: ir.lexariabioscience.com/presentations.

About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 21 patents granted in nations with a combined population of 2.6 billion, and over 50 additional patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals or prohibitions, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



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Positive results using DehydraTECH-CBD support progressing to FDA IND application

KELOWNA, BC / September 8, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms today announced it is formally beginning the process towards an Investigational New Drug ("IND") application filing with the Food and Drug Administration ("FDA") with its DehydraTECH-processed cannabidiol ("DehydraTECH-CBD") as a prospective registered pharmaceutical treatment for hypertension.

Lexaria has retained the services of an expert regulatory affairs and quality assurance consultancy group that will help prepare Lexaria for a pre-IND meeting with the FDA, as well as with designing the necessary non-clinical, clinical and related product development IND-enabling work to be completed in advance of the IND filing.

Lexaria's new IND enabling program is made possible through successfully completed studies that have provided support for more ambitious commercial goals. Recently achieved successful results from two 2021 human clinical pharmacodynamic hypertension studies and a 2018 human clinical pharmacokinetic ("PK") study, along with a number of successful animal studies demonstrating PK performance and molecular characterization work completed through Canada's National Research Council, have together established a strong body of evidence for Lexaria's DehydraTECH-CBD. These studies have shown that DehydraTECH-CBD demonstrates superior bioabsorption upon oral administration and is effective at reducing blood pressure with no significant unwanted side effects.

Provided that ongoing and upcoming studies continue to deliver favorable results, and that IND and other approvals from regulators are obtained, Lexaria intends to progress to a New Drug Application ("NDA") at the appropriate time, possibly via the abbreviated 505(b)(2) pathway.

The IND application process is also expected to utilize data from the Company's third and fourth 2021 human clinical hypertension studies, whereby Lexaria hopes that these studies will contribute further valuable data to its growing information package.

Lexaria will provide details on the timing and specifics of its planned pre-IND meeting and of the non-clinical, clinical and related product development IND-enabling work program elements to be completed in advance of and to culminate in IND filing as these details become available.

In addition, Lexaria is evaluating whether additional therapeutic indications for DehydraTECH-CBD might be pursued with the FDA in due course.

About DehydraTECH-CBD

DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure.

CBD in the Regulatory Environment.

CBD under the brand name Epidiolex® was approved by the FDA in June 2018 for treating certain types of pediatric seizure disorders. Recommended dosing of Epidiolex CBD is 2.5 mg per kilogram of bodyweight to begin treatment, taken twice per day, increasing to 5.0 mg per kilogram of bodyweight, taken twice per day. An average 9 year-old child weighs about 28 kg, so the FDA recommended dose of Epidiolex would initially be 140 mg, increasing to 280 mg daily for long term use. The average adult man in the US weighs 199.6 lbs (90.7kg), so if he was using CBD at that same rate, he would require 900 mg per day for a sustainable dose. The maximum FDA-approved dose of Epidiolex is 10.0 mg per kilogram of bodyweight, taken twice daily.

Hypertension Markets

The hypertension market is valued at $28 billion per year and is expected to continue growing as one of the world's top health problems. Geographically, some of the highest rates of growth are expected in more recently industrialized nations such as China and India. Over 1.1 billion people worldwide suffer from hypertension.

Fewer than 1 person in 4 with hypertension have successfully controlled their blood pressure through medications, meaning the potential market for hypertension drugs is much larger than $28 billion per year if an affordable drug was available with few or no side effects. Lexaria believes that its DehydraTECH-CBD may introduce a more tolerable anti-hypertensive treatment option that may be used alone or in combination with other medications, to reduce BP with fewer discouraging and unwanted side effects. Lexaria would seek to satisfy this currently unmet demand and in doing so could expand the overall hypertension market.

"Among persons 50 years of age or older, isolated systolic hypertension is the most common form of hypertension, and systolic blood pressure becomes more important than diastolic blood pressure as an independent risk predictor for coronary events, stroke, heart failure, and end-stage renal disease (ESRD). The Global Burden of Disease Study identified elevated blood pressure as the leading risk factor, among 67 studied, for death and disability-adjusted life-years lost during 2010."

Drugs focused on blood pressure and related conditions are some of the highest selling drugs in the world. Lipitor, used to treat high cholesterol and reduce the risk of heart disease, has generated $94.7 billion in revenue from 1992 until 2017. Plavix, used to prevent heart attack and stroke, has sold $46.5 billion from 1992 until 2017. There are several hypertension drugs that each generate $1 billion per year or more in revenue.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 21 patents granted in nations with a combined population of 2.6 billion, and over 50 additional patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals or prohibitions, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

[email protected]

Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



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Human Clinical Study HYPER-H21-2 evidences up to a remarkable 23% decrease in blood pressure with patented DehydraTECH-CBD relative to placebo

KELOWNA, BC / September 7, 2021 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is extremely pleased to issue initial results from human clinical study HYPER-H21-2 evaluating DehydraTECHTM-processed cannabidiol ("CBD") for potential application against hypertension. Partial results related to blood pressure ("BP") are being released today, while additional BP subset analyses, sleep quality and all other data analyses are in progress and will be reported upon when complete.

At selected times during the 24-hour study, volunteers with mild to moderate hypertension averaged as much as a 20 mmHg (i.e., 23%) decrease in BP relative to placebo.

Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 7.0% (p < 0.001) in systolic pressure with DehydraTECH-CBD relative to placebo as shown below in Figure 1.

Figures 1, 2, and 3 below: Changes in 24-hr ambulatory systolic pressure ( SBP), mean arterial pressure ( MAP) and diastolic pressure ( DBP) between placebo (blue) and DehydraTECH-CBD (purple). Data are grouped means (n=16) with linear regression denoted by the trend lines. Timing of the three administered doses of DehdyraTECH-CBD (150 mg CBD x 3 dosing intervals) is indicated by the vertical arrows.

Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 5.3% (p < 0.001) in MAP with DehydraTECH-CBD relative to placebo, as shown below in Figure 2.

Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 3.5% in diastolic pressure relative to an increase in diastolic pressure (-0.8 vs. +2.7; p<0.001) from baseline with DehydraTECH-CBD relative to placebo, as shown below in Figure 3.

Lead investigator Dr. Phil Ainslie, Professor, School of Health and Exercise Sciences and Co-Director, Centre for Heart, Lung & Vascular Health, University of British Columbia Okanagan, and Canada Research Chair in Cerebrovascular Physiology, commented, "These improvements in BP results are particularly remarkable given the fact that many existing drugs used to treat hypertension require several weeks of treatment and/or combination dosing before they produce comparable reductions in blood pressure.

"Over the initial 24 hours, Lexaria's 2021 hypertension program is now delivering blood pressure reduction results competitive with - and in some cases even superior to - established oral pharmaceutical hypertension drugs," said Chris Bunka, CEO of Lexaria. "DehydraTECH-CBD demonstrated a sustained and augmented effect upon blood pressure attenuation throughout the day, indicating effectiveness of the repeat dosing treatment schedule used in this study."

DehydraTECH-CBD triggered its most significant effects upon BP attenuation through the overnight period while subjects slept and in the early morning period. This observation could have tremendous value therapeutically as these periods of the day are most often associated with cardiac stress and infarct events in hypertensive patients when people rise suddenly from and/or become increasingly active relative to the supine/sleeping state.

Analysis of the physical activity levels of the volunteers with mild to moderate hypertension during the 24-hour monitored period showed no significant differences in activity between the placebo and the DehydraTECH-CBD treated volunteers, indicating that the observed differences in BP were not due to disparate physical movement or demands.

Other studies of coronary heart disease ("CHD") have concluded that "lowering systolic pressure by 10 mmHg or diastolic pressure by 5 mmHg using any of the main classes of drugs reduced CHD events (fatal and nonfatal) by about a quarter and stroke by about a third, regardless of the presence or absence of vascular disease and of pretreatment BP. Heart failure is also reduced by about 25%."

Lexaria was also pleased that, as in past studies, its DehydraTECH-CBD was well tolerated by all subjects, with no serious adverse events or side effects observed or reported or incidence differences between groups. Over 100 million adult Americans have high blood pressure, but only one in four of those have the condition under control. Many patients stop taking their medications because of troublesome side effects: some diuretics can cause excessive urination, beta blockers can cause erectile dysfunction, calcium-channel blockers can cause leg swelling, and ACE inhibitors can lead to persistent cough. Lexaria believes that its DehydraTECH-CBD may introduce a more tolerable anti-hypertensive treatment option that may be used alone or in combination with other medications, to reduce BP with fewer discouraging and unwanted side effects.

Next Steps

Data analysis from this study is continuing and additional outcomes will be reported upon when complete. On July 29, 2021, Lexaria reported it was "optimistic that repeat dosing such as this over a sustained period may further enhance efficacy," and is delighted to have now shown this by way of the 3-dose and 24-hour monitoring used in study HYPER-H21-2. The results of these first two human clinical hypertension studies are being carefully evaluated and considered before Lexaria's third planned human clinical (pulmonary) hypertension study of 2021 begins, expected this Fall.

With the positive results generated from these first two 2021 human clinical studies, Lexaria reaffirms its intention to also pursue a fourth hypertension study. Study design considerations are already underway with expectations to include a larger hypertensive population, regular monitoring of BP over at least a 4-week duration designed to monitor longer term performance and tolerability, and measurements of inflammatory and oxidative markers as well as overall vascular health.

Given the remarkable reduction in BP of up to 20 mmHg, Lexaria will be investigating whether similar decreases might be achievable over longer periods of time which could lead to effective long term BP treatment strategies.

About DehydraTECH-CBD

DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure.

About Human Study HYPER-H21-2

Human Study HYPER-H21-2 was conducted at a European medical research hospital. Sixteen human volunteers (8 male; 8 female) aged 45-65 with otherwise untreated pre- or mild-hypertension were given either a placebo, or three separate doses of 150 mg each of DehydraTECH-CBD over a 14-hour period and studied over a 24-hour duration. The average weight and height were 91 ± 13 kg and 173 ± 9 cm. Ambulatory blood pressure was recorded for 24 hours. Additional BP subset analyses, sleep quality and all other data analyses are in progress and will be reported upon when complete.

CBD in the Regulatory Environment.

CBD under the brand name Epidiolex® was approved by the FDA in June 2018 for treating certain types of pediatric seizure disorders. Recommended dosing of Epidiolex CBD is 2.5 mg per kilogram of bodyweight to begin treatment, taken twice per day, increasing to 5.0 mg per kilogram of bodyweight, taken twice per day. An average 9 year-old child weighs about 28 kg, so the FDA recommended dose of Epidiolex would initially be 140 mg, increasing to 280 mg daily for long term use. The average adult man in the US weighs 199.6 lbs (90.7kg), so if he was using CBD at that same rate, he would require 900 mg per day for a sustainable dose. The maximum FDA-approved dose of Epidiolex is 10.0 mg per kilogram of bodyweight, taken twice daily.

Hypertension Markets

The hypertension market is valued at $28 billion per year and is expected to continue growing as one of the world's top health problems. Geographically, some of the highest rates of growth are expected in more recently industrialized nations such as China and India. Over 1.1 billion people worldwide suffer from hypertension - elevated blood pressure. Hypertension is a major risk factor for cardiovascular and cerebrovascular disease, and accounts for approximately 45% of cardiovascular disease mortality and morbidity worldwide.

"Among persons 50 years of age or older, isolated systolic hypertension is the most common form of hypertension, and systolic blood pressure becomes more important than diastolic blood pressure as an independent risk predictor for coronary events, stroke, heart failure, and end-stage renal disease (ESRD). The Global Burden of Disease Study identified elevated blood pressure as the leading risk factor, among 67 studied, for death and disability-adjusted life-years lost during 2010."

Drugs focused on blood pressure and related conditions are some of the highest selling drugs in the world. Lipitor, used to treat high cholesterol and reduce the risk of heart disease, has generated $94.7 billion in revenue from 1992 until 2017. Plavix, used to prevent heart attack and stroke, has sold $46.5 billion from 1992 until 2017. There are several hypertension drugs that each generate $1 billion per year or more in revenue.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 21 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



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https://www.accesswire.com/662848/Lexarias-Human-Clinical-Study-Delivers-Effective-and-Safe-Blood-Pressure-Reduction-Results-over-24-hour-Ambulatory-Period

Human Clinical Study HYPER-H21-1 evidences a rapid and sustained drop in blood pressure with DehydraTECH-CBD and excellent tolerability

KELOWNA, BC / July 29, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is extremely pleased to issue partial results from human clinical study HYPER-H21-1 evaluating DehydraTECHTM-processed cannabidiol ("CBD") for potential application against hypertension. Partial results related to blood pressure ("BP") are being released today, while additional BP subset analyses and all other data analyses including pharmacokinetic ("PK") evaluations and detailed blood chemistry work is in progress and will be released when complete.

"We are very encouraged by these early results in our 2021 hypertension program," said Chris Bunka, CEO of Lexaria. "Lexaria's technology enabled a rapid and sustained drop in blood pressure, especially systolic pressure and particularly in Stage 2 hypertensive volunteers."

Lead investigator Dr. Phil Ainslie, Professor, School of Health and Exercise Sciences and Co-Director, Centre for Heart, Lung & Vascular Health University of British Columbia Okanagan, and Canada Research Chair in Cerebrovascular Physiology, commented that, "these early results are extremely promising in this at-risk hypertensive population and provide a fundamental support for expansion into more prolonged repeat dosing and future longer term clinical trials."

BP was reduced across both male and female volunteers and was most pronounced with DehydraTECH-CBD in the first 10-50 minutes of the study, reinforcing our pre-existing findings demonstrating that DehydraTECH delivers superior performance over generic CBD controls.

Blood pressure reduction from baseline was greatest when measured via systolic pressure. In the subset of volunteers who were Stage 2 hypertensive, peak systolic BP reductions from baseline were observed of as much as approximately 13 mmHg by the 50-minute time point with DehydraTECH-CBD, and systolic BP remained depressed throughout almost the entire 3-hour duration of the study. For reference, other studies of coronary heart disease ("CHD") have concluded that "lowering systolic pressure by 10 mm Hg or diastolic pressure by 5 mm Hg using any of the main classes of drugs reduced CHD events (fatal and nonfatal) by about a quarter and stroke by about a third, regardless of the presence or absence of vascular disease and of pretreatment BP. Heart failure is also reduced by about 25%."

There was also a tendency for a greater reduction in relative diastolic pressure from baseline with DehydraTECH-CBD than the concentration matched, generic CBD control (Fig 1). This was most notable in the initial 10-20 minute period post-dosing evidencing statistical significance at the 20-minute timepoint (p=0.025).

Fig 1. Changes in diastolic blood pressure between generic CBD control (dose A) and DehydraTECH-CBD (dose B). Data are grouped means (n=24) with linear regression.

As well, there was a tendency for relative Mean Arterial Pressure ("MAP") to be reduced greater from baseline with the DehydraTECH-CBD than the concentration matched, generic CBD control; again, most notably in the initial 20 minutes post-dosing (Fig 2.). By comparison, in Lexaria's 2018 human clinical study, 120 minutes were required to achieve the same level of MAP reduction, demonstrating superior rapidity of onset of the "DehydraTECH 2.0" CBD formulation used in the present study relatively speaking.

Fig 2. Changes in mean arterial blood pressure between generic CBD control (dose A) and DehydraTECH-CBD (dose B). Data are grouped means (n=24) with linear regression.

Lexaria was also pleased that its DehydraTECH-CBD was well tolerated by all subjects, with no serious adverse events or side effects observed or reported. Ingestion of the concentration-matched, generic CBD control, on the other hand, resulted in unwanted side effects in some of the volunteers, namely gastrointestinal distress including diarrhea. These findings corroborate what Lexaria has previously evidenced in other unrelated studies whereby human volunteers have also experienced reduced side effects with DehydraTECH-processed test articles compared to concentration-matched, generic controls.

Lexaria looks forward to completing its ongoing additional sample and data analyses work for this study and reporting upon those outcomes when complete. Lexaria's second human clinical hypertension study of 2021, study HYPER-H21-2, has completed dosing as previously reported and, in that study, three separate doses of DehydraTECH-CBD (150mg per dose) were used, administered evenly over the course of a 24-hour monitoring period. Based on the BP reducing trends witnessed in the present study, Lexaria is optimistic that repeat dosing such as this over a sustained period may further enhance efficacy. The results of these two studies will be carefully evaluated and considered before Lexaria's third planned human clinical hypertension study of 2021 begins, expected this Fall. Lexaria is evaluating study considerations for a fourth, expanded, randomized, controlled human clinical hypertension trial, with a view to building upon the results of current investigations in a larger population for enhanced statistical and clinical significance.

About Human Study HYPER-H21-1
Human Study HYPER-H21-1 was conducted at a European medical research hospital. Twenty-four human volunteers aged 45-65 with otherwise untreated pre- or mild-hypertension were given either a single 300mg dose of generic CBD, or a single 300mg dose of DehydraTECH-CBD and studied over a 3-hour duration. The weight of the average woman in the study was 178 lbs, and the weight of the average man in the study was 223 pounds. Blood pressure and heart rate analyses were taken every 10 minutes and speed and rate of absorption of the CBD and its main metabolites (PK assessments) were also assessed during the study. Secondary analyses that will be reported when complete include evaluation of inflammatory and oxidative markers associated with cardiovascular disease and gold-standard biomarkers of nitric oxide. This latter measure provides mechanistic insight into the reduction in blood pressure via vasodilation.

Inflammatory marker assessments may also be applicable to Lexaria's research initiatives in the antiviral therapeutics space whereby effective anti-inflammatory therapies are also useful in treating diseases like COVID-19 or other common pro-inflammatory conditions, where Lexaria has already successfully demonstrated DehydraTECH utility with one such anti-inflammatory drug, colchicine, used for COVID-19 treatment today as previously reported.

CBD in the Regulatory Environment.
CBD under the brand name Epidiolex was approved by the FDA in June 2018 for treating certain types of pediatric seizure disorders. Recommended dosing of Epidiolex CBD is 2.5mg per kilogram of bodyweight to begin treatment, taken twice per day, increasing to 5.0mg per kilogram of bodyweight, taken twice per day. An average 9 year-old child weighs about 28 kg, so the FDA recommended dose of Epidiolex would initially be 140mg, increasing to 280mg daily for long term use. The average adult man in the US weighs 199.6 lbs (90.7kg), so if he was using CBD at that same rate, he would require 900mg per day for a sustainable dose. The maximum FDA-approved dose of Epidiolex is 10.0mg per kilogram of bodyweight, taken twice daily.

Hypertension Markets
The Hypertension market is valued at $28 billion per year and is expected to continue growing as one of the world's top health problems. Geographically, some of the highest rates of growth are expected in more recently industrialized nations such as China and India. Over 1.1 billion people worldwide suffer from hypertension - elevated blood pressure.

"Among persons 50 years of age or older, isolated systolic hypertension is the most common form of hypertension, and systolic blood pressure becomes more important than diastolic blood pressure as an independent risk predictor for coronary events, stroke, heart failure, and end-stage renal disease (ESRD). The Global Burden of Disease Study identified elevated blood pressure as the leading risk factor, among 67 studied, for death and disability-adjusted life-years lost during 2010."

Drugs focused on blood pressure and related conditions are some of the highest selling drugs in the world. Lipitor, used to treat high cholesterol and reduce the risk of heart disease, has generated $94.7 billion in revenue from 1992 until 2017. Plavix is used to prevent heart attack and stroke, has sold $46.5 billion from 1992 until 2017. There are several hypertension drugs that each generate $1 billion per year or more in revenue.

About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s proprietary drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting healthier oral ingestion methods and increasing the effectiveness of fat-soluble active molecules, thereby lowering overall dosing. The Company's technology can be applied to many different ingestible product formats, including foods, beverages, oral suspensions, tablets, and capsules. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is planned to be further evaluated for orally administered bioactive molecules, including anti-viral drugs, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs) and more. Lexaria has licensed DehydraTECH to multiple companies including a world-leading tobacco producer for the development of smokeless, oral-based nicotine products and for use in industries that produce cannabinoid beverages, edibles, and oral products. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 21 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as 'anticipate,' 'if,' 'believe,' 'plan,' 'estimate,' 'expect,' 'intend,' 'may,' 'could,' 'should,' 'will,' and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/657567/Lexarias-DehydraTECH-CBD-Lowers-Blood-Pressure