Dosing is expected to begin by April, 2022

KELOWNA, BC / December 29, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to report that Independent Review Board ("IRB") approval has been received ahead of schedule for its upcoming DehydraTECH-CBD human hypertension study HYPER-H21-4.

This study should "de-risk" outcomes prior to Lexaria's planned entry into regulatory pathways for the use of 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. Dosing is tentatively scheduled to begin by April, 2022.

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 a placebo control. Some volunteers will already be using leading standard of care hypertension drugs such as ACE inhibitors with or without diuretics which will 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 of DehydraTECH-CBD over time and will evaluate the potential for longer term health benefits.

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 (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 long-term health benefits of DehydraTECH-CBD that might otherwise remain undetected.

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 and as a subset of the larger heart disease market. 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), PDE5 inhibitors 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:
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/679972/Lexaria-Receives-Independent-Review-Board-Approval-For-DehydraTECH-CBD-Human-Clinical-Study-HYPER-H21-4

KELOWNA, BC / December 16, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has entered into an advertising and media agreement (the "Contract") for media buys and digital marketing with SRAX, Inc. ("SRAX").

"Lexaria is pleased to be working with SRAX to inform and engage a broad investor community in this significant, year-long media outreach campaign," said Chris Bunka, CEO of Lexaria Bioscience. "Lexaria has made tremendous progress during 2021 and we expect even more significant advancement in 2022 and are pursuing the broadest possible investor involvement to ensure that Lexaria's achievements are communicated to all investors."

Lexaria is planning for 2022 to be its busiest year ever, with major studies and events already announced that include:

  • a six-week human clinical hypertension study to evaluate DehydraTECH-CBD for possible relief of hypertension;
  • an industry-leading oral nicotine human study including both subjective evaluation and objective blood measurements expected to demonstrate the superiority of DehydraTECH-nicotine compared to leading industry products;
  • a program of animal studies designed to evaluate DehydraTECH-CBD for seizure relief and comparison against the only existing FDA-approved CBD medication currently in use for treatment of certain seizure disorders; and
  • our expectation of completing a pre-IND meeting with the FDA, and subsequently filing an IND application, for registered clinical trial testing of DehydraTECH-CBD for hypertension.

Along with those major studies Lexaria will also be conducting a number of pharmacokinetic studies designed to provide potential early-stage indications of enhancing delivery characteristics of various drugs for potential future use. In aggregate, the quantity of work to be performed demands the maximum visibility possible to the investor community and therefore should be maximized with a sustained and intelligent marketing campaign.

Pursuant to the Contract, SRAX will act as the agent for Lexaria and will engage and manage media companies to create advertising materials and distribute them on internet platforms and manage the flow of such media distributions (the "Services"). SRAX will employ leading-edge analytical algorithms to maximize engagement. As consideration for the Services, Lexaria will issue SRAX an aggregate 224,299 restricted common shares from its authorized share capital (the "Shares") at a deemed price of $5.35 per share for an aggregate value of $1,200,000.

The Shares have not been registered under the Securities Act of 1933, as amended (the "Securities Act") or any state securities laws. The issuance of the Shares will be in reliance on the exemptions from registration provided by Section 4(a)(2) under the Securities Act.

About SRAX

SRAX (SRAX) is a financial technology company that unlocks data and insights for publicly traded companies. Through its premier investor intelligence and communications platform, Sequire, companies can track their investors' behaviors and trends and use those insights to engage current and potential investors across marketing channels. For more information on SRAX, visit srax.com and mysequire.com.

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), PDE5 inhibitors 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:

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/678184/Lexaria-Enters-One-Year-Media-Outreach-Agreement-with-SRAX-Inc

KELOWNA, BC / December 14, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that its human clinical study HYPER-H21-3 is expected to complete all dosing and sample collection this week.

Formal hospital and ethics board approvals for human clinical study HYPER-H21-3 had been received in March. Study HYPER-H21-3 used a placebo-controlled and blinded design, with administration of a single 300mg dose of a specific DehydraTECH 2.0 CBD formulation compared to placebo in a target group of sixteen enrolled volunteers. This "Stress Test" study was undertaken to examine the effects of DehydraTECH-CBD upon acute pulmonary hypertension. Blood samples collected from this study will be subjected to analysis and the blood pressure results are expected to be reported soon.

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 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 is being collected and analysis is ongoing.

Results from study HYPER-H21-3 are expected to add to Lexaria's growing body of evidence for the effectiveness of DehydraTECH-CBD against hypertension, and will be submitted to regulators such as the FDA, as the Company pursues its planned investigational new drug research program. Lexaria offers its gratitude to the teams of experts conducting its series of three human clinical studies through 2021 overwhelmingly on schedule and on budget particularly during the past year when challenges from the COVID-19 epidemic were pronounced.

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), PDE5 inhibitors 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:

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/677626/Lexarias-Clinical-Hypertension-Study-HYPER-H21-3-Nears-Completion

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.



View source version on accesswire.com:
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.



View source version on accesswire.com:
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.



View source version on accesswire.com:
https://www.accesswire.com/667925/Lexarias-Technology-Proven-to-Deliver-Oral-THC-More-Effectively

  • 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.



View source version on accesswire.com:
https://www.accesswire.com/666759/Lexaria-Oral-Nicotine-Study-NIC-A21-1-Delivers-Outstanding-Results

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.



View source version on accesswire.com:
https://www.accesswire.com/663260/Lexaria-to-Present-at-the-HC-Wainwright-23rd-Annual-Global-Investment-Conference

1 2 3 5