DehydraTECH-powered GLP-1 drugs will be evaluated for potential improvements such as:

  • Reduced side effects;
  • Enhanced weight loss;
  • Improved health outcomes for diabetes and other conditions;
  • Improved oral bioavailability;
  • Reduced cost.

KELOWNA, BC / September 21, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces its intention to launch new human and animal studies to examine DehydraTECH™-processed glucagon-like peptide-1 ("GLP-1") drugs such as, but not limited to, semaglutide sold under Novo Nordisk's brand names Ozempic®, Wegovy® and Rybelsus®, for purposes of improved bioavailability, cost-effectiveness, tolerability, weight loss potential, management of diabetes and other health conditions.

Through these studies, Lexaria hopes to achieve superior pharmacokinetic ("PK") performance using DehydraTECH-powered GLP-1 drugs which could enable drug delivery via oral capsule at lower costs than current injectables, with reduced side effects and enhanced health benefits.

This is a significant expansion of Lexaria's ongoing and planned diabetes study program to examine its patented DehydraTECH-CBD for diabetes control in humans. The Company now intends to evaluate this alongside and together with DehydraTECH-processed GLP-1 agents. Program design has already commenced, and initial study work will begin as soon as possible.

Lexaria has demonstrated in many previous R&D programs, including five human clinical studies, that DehydraTECH can greatly improve the PK performance of many orally administered drugs into the bloodstream, such as certain antiviral drugs, estradiol, PDE-5 Inhibitors, cannabinoids and more. Like many of these agents, GLP-1 drugs also exhibit low oral bioavailability without the use of absorption enhancement technology, such as Lexaria's DehydraTECH. Lexaria has also previously shown in animal studies that its patented DehydraTECH-CBD lowered body weight over a sustained dosing period by 7%, and also lowered blood sugar and triglyceride levels.

The Company has also demonstrated that specific customized DehydraTECH oral capsule formulations can achieve remarkable improvements in PK performance. For example, the particular DehydraTECH-CBD formulation that was used in its recently completed DIAB-A22-1 diabetes study demonstrated almost a 3-fold improvement in drug delivery into blood than the differentiated DehydraTECH-CBD formulation that was used in Lexaria's HYPER-H21-4 hypertension study that, itself, demonstrated significantly better PK performance and effectiveness than pharmaceutical-grade CBD industry comparators like Epidiolex®.

About GLP-1 Drugs.

GLP-1 drugs have recently been approved by the Food and Drug Administration ("FDA") for type two diabetes and weight loss management. Weight loss of between 10 pounds to 33 pounds, or more, has been widely reported. One 68-week study of 667 people reported an average loss of 15% of body weight.

Widely reported anecdotal commentary is also suggesting that some patients are experiencing reduced cravings for alcohol, nicotine and opioids while taking GLP-1 drugs. Other trials are examining their effects on heart disease and even dementia in part because of evidence that GLP-1 drugs may reduce the build-up of the proteins amyloid and tau in the brain, thought to be partly responsible for Alzheimer's disease.

Side effects of the GLP-1 drugs vary but can include nausea, vomiting, diarrhea and more. A small number of GLP-1 drugs have already been approved in oral format but some studies have reported worse side effects with the oral form. The drugs are also being investigated for their relationship to bone density, muscle loss and more. Because of potential serious side effects, it may be beneficial to treat patients with lower oral doses of the drugs, something that Lexaria's DehydraTECH technology may enable if it can improve the PK performance of GLP-1 drugs through oral capsules.

Although the GLP-1 drugs are effective at controlling diabetes and promoting weight loss, they are expensive, and the benefits often reverse if the patient stops taking the drug. Typical non-insured costs of US$900/month or more are common. If DehydraTECH improves the PK performance of oral GLP-1 drugs it could potentially result in cost savings for the patient through lower doses.

Because GLP-1 drugs have experienced FDA approvals as recently as 2021 and 2022, and because the health benefits of this drug class are still being discovered and understood, the potential market size is still unknown. Published reports are widely estimating $100 billion in sales per year, by 2030. At least one analyst from Guggenheim Partners published a note on September 12 in which he explained how "the total addressable market for these so-called incretin drugs could balloon to $150 billion to $200 billion."

About Lexaria's Diabetes Study Program.

Lexaria began its DehydraTECH diabetes-related formal studies in 2022. On March 2, 2023 and June 16, 2023 Lexaria announced that in pre-clinical diabetes study DIAB-A22-1 in obese diabetic-conditioned animals, DehydraTECH-CBD achieved each of the following:

  • Lowered blood glucose levels by 19.9% (p<0.05)
  • Lowered overall body weight by 7% sustained over 8 weeks
  • Increased locomotor activity (p<0.05)
  • Lowered triglyceride levels by more than 25% (p<0.007)
  • Lowered blood urea nitrogen levels by 27.9% (p<0.001)

On August 2, 2023 Lexaria announced its intention to study weight loss and diabetes control in a human population using DehydraTECH-CBD.

Lexaria's goals within its diabetes study program have significantly expanded and now include the concept of applying DehydraTECH technology, individually, to each of CBD and GLP-1 drug(s), but also to potentially utilize a combination of drugs that includes both a GLP-1 component and DehydraTECH-CBD, together. At this time, no other company in the world is utilizing DehdyraTECH technology relative to GLP-1 drugs.

DehydraTECH-CBD's ability to reduce blood sugar levels in animals is extremely encouraging and warrants additional investigation. According to the Center for Disease Control, managing your blood sugar levels is important to avoid diabetes-related conditions such as vision loss, heart disease, and kidney disease. Limited research, mostly in animal studies, indicates that without DehydraTECH's noteworthy performance enhancements, generic CBD might be ineffective in controlling blood sugars.

About DehydraTECH

DehydraTECH is a patented drug delivery formulation and processing platform technology Lexaria has developed and is investigating for a variety of beneficial molecules. 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 into brain tissue, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria has also developed DehydraTECH formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, 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 36 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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/786174/lexaria-to-evaluate-impact-of-dehydratech-on-oral-performance-of-glp-1-drugs-used-in-products-such-as-ozempic-wegovy-and-rybelsus-alone-or-together-with-dehydratech-cbd

KELOWNA, BC / August 30, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is providing this update on the status of the Company's anticipated submission of an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for its planned U.S. Phase 1b Hypertension Clinical Trial designated as HYPER-H23-1.

As previously reported, work that was mostly under Lexaria's control such as batch manufacturing of DehydraTECH™-processed cannabidiol and placebo materials necessary for the IND application filing was completed earlier this year, followed by analytical release and ongoing stability testing.

In parallel, compilation of the large set of documentation necessary for inclusion in the IND filing has been progressing on time by the Company and its service providers. However, work that is outside of Lexaria's control, namely the provision of required documentation by one of Lexaria's material suppliers related to their analytical and stability testing of their material, has been delayed. Accordingly, Lexaria is not in a position to submit the IND package to the FDA for their review and consideration until these delays have been cured by the supplier.

Lexaria is in communication with its material supplier to provide their required information as soon as possible but, as at the current date, we have not received the results nor an estimated time of receipt for same. Lexaria continues to finalize the IND application so that the Company is in a position to file with the FDA as soon as possible following receipt of the outstanding information and will provide updated details regarding the status of its IND application filing as they become available.

Background and Medical/Market Rationale

Lexaria's five previous human clinical studies of DehydraTECH-CBD in hypertension conducted from 2018 through 2022, which were not conducted under FDA-registration but are integral to successful filing and review of its planned IND submission, were carried out in an aggregate total of 134 healthy and hypertensive persons. These foundational studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens, and also produced zero serious adverse events; suggesting that DehydraTECH-CBD has the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics.

Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this. DehydraTECH-CBD is currently unique in its evidenced superior power to reduce blood pressure over other oral CBD formulations.

Findings from Lexaria's latest study HYPER-H21-4 demonstrated a potentially novel mechanism of action of DehydraTECH-CBD in reducing blood pressure which may be explained, at least in part, by its interaction with the human sympatho-chromaffin system via catestatin modulation as detailed in thepeer-reviewed and published respected journal, "Biomedicine and Pharmacotherapy". This is significant because the FDA has previously laid out clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer novel and complementary modes of action. Data gathered from study HYPER-H21-4 suggested that DehydraTECH-CBD had the potential to offer additive blood pressure reduction benefits on top of any degree of improvements that standard of care medications achieved for patients prior to DehydraTECH-CBD dosing.

About Planned Clinical Trial HYPER-H23-1

Clinical trial HYPER-H23-1 is entitled ‘A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension'. The primary objective of the trial will be to evaluate safety and tolerability in hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.

All clinical, laboratory and analysis procedures for study HYPER-H23-1 are to be performed entirely by U.S.-based, third-party independent contract service providers.

About DehydraTECH

DehydraTECH is a patented drug delivery formulation and processing platform technology Lexaria has developed and is investigating for a variety of beneficial molecules. 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 into brain tissue, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria has also developed DehydraTECH formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, 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 35 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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/778356/Lexaria-Provides-Update-on-Investigational-New-Drug-Application-Progress

  • DehydraTECH-Nicotine reaches maximum blood saturation levels faster than world-leading brands from Swedish Match and Altria in human study NIC-H22-1
  • Noteworthy superior subjective performance characteristics also observed

KELOWNA, BC / August 9, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to report results from its 2023 human oral nicotine study NIC-H22-1 comparing Lexaria's DehydraTECH™-Nicotine tobacco-free pouch to world-leading brands ZYN® (from Swedish Match) and on!® (from Altria Group Inc's subsidiary Helix Innovations LLC).

Lexaria's oral nicotine pouch was statistically significantly faster in the median time required to reach comparable maximum nicotine concentrations within the bloodstream ("Tmax"), than both on! and ZYN. DehydraTECH-Nicotine was 15.0% faster in reaching Tmax levels than on! and 20.2% faster than ZYN:

Lexaria

on!

ZYN

Tmax (minutes)

15.37

17.67

p=0.004

18.48

p=0.000

"With just five short years of R&D and product development, Lexaria has been able to develop an oral nicotine product that meets or exceeds the performance of the world's leading existing brands," said Chris Bunka, CEO of Lexaria Bioscience. "This is a remarkable achievement that speaks to the capabilities of the DehydraTECH technology and also to the Lexaria R&D team, working ardently with scarce resources relative to global multi-billion-dollar behemoths. We've always had an overwhelming determination and fierce conviction that we can make the world a better place and reduce the carnage caused by smoked cigarettes, and now we have human study data that demonstrates advantages of DehydraTECH processed nicotine relative to the competitive landscape."

According to a pharmacokinetic study, both combustible cigarettes and "heat-not-burn" tobacco-containing devices require roughly 8 minutes to reach Tmax. Using this standard cigarette Tmax delivery time as a base, the ZYN pouch was 131% slower and the on! pouch was 121% slower than a smoked cigarette to reach Tmax. The Tmax times of a number of nicotine product formats at comparable dose levels used in study NIC-H22-1 are shown in the table below, taken from the published 2009 study Nicotine Chemistry, Metabolism, Kinetics and Biomarkers, showing the relative Tmax time delay (%) per product compared to cigarette use. Generally speaking, rapid delivery of nicotine is a vital component of the potential for product adoption for use by consumers.

Product

Tmax (mins)

Percent Time Delay

Combusted cigarette

8.0

-

on! oral pouch

17.67

121%

Nasal spray

up to 18

up to 125%

ZYN oral pouch

18.48

131%

Subcutaneous injection

25

213%

Gum

30.0

275%

Lozenge

60.0

650%

Oral solution

66

725%

DehydraTECH-Nicotine
oral pouch

15.37

92%

Avoiding or minimizing harm is a major objective of oral nicotine products. Another study reported that heat-not-burn devices delivered as much as 27.9% of the same harmful and potentially harmful constituents delivered by combusted cigarettes. These include substances such as nitrosamines and polycyclic aromatic hydrocarbons such as benzene. By comparison, non-combusted oral nicotine pouch products with no tobacco and nicotine replacement therapies, have been shown to deliver non-quantifiable levels of these harmful substances for superior safety and tolerability. The FDA has indeed issued a reduced-risk notice for smokeless type products.

Subjective Analyses
Detailed questionnaires were administered to all participants in the study, for each test article, to assess subjective effects and determine the "human experience" while using the products. While the findings lacked statistical significance in most instances, possibly due to sample size limitations, a number of intriguing data trends were observed.

In general, the fact that the Tmax was faster with Lexaria compared to both on! and ZYN, seemed to support apparent trends towards higher levels of certain pleasurable effects, sooner, with the Lexaria product. Conversely, the lowest frequency of certain unwanted negative effects such as moderate to severe nausea were reported from the Lexaria product users, demonstrative of some of the patented formulation benefits of Lexaria's DehydraTECH.

  • Euphoria and Head Rush. The highest percentage of users reporting that they felt euphoric at all time points were the Lexaria users; and the highest percentage of users reporting they felt a head rush at the 5 and 30-minute marks were also Lexaria users.
  • Tolerability. The highest endorsement score for users reporting "I tolerated this product well" were the Lexaria users, with statistical significance demonstrated at the second dosing visit in particular (p=0.007).
  • Pleasure. The highest percentage of users reporting that they considered the experience "pleasurable" at the 30-minute mark were the Lexaria users, while the on! users reported the lowest percentage as "pleasurable" at this point.
  • Mouth and Throat-burn. Lexaria scored best for percent enjoyment of the nicotine induced burning sensation in the mouth and throat. The highest percentage of severe mouth and throat-burn events were reported by users of the on! pouch.
  • Nausea. The highest frequency of moderate and severe nausea effects were reported by users of the ZYN and on! pouches respectively; with the lowest frequency reported by users of the Lexaria pouch.
  • Hiccups. Moderate to severe hiccups were only reported by users of the on! and ZYN products.

Lexaria's recent US patent award covering its novel oral-nicotine formulations powered by DehydraTECH only adds to the value of Lexaria's nicotine strategies and erects hurdles against would-be copycat industry participants. Further product development and optimization work could lead to increased performance to DehydraTECH-Nicotine. For example, both on! and ZYN are understood to utilize nicotine bitartrate dihydrate as their nicotine raw material inputs whereas Lexaria's formulation for this study utilized nicotine benzoate. Study work in animals has shown apparent trends toward much higher peak blood level delivery following nicotine tartrate injection compared to nicotine benzoate injection, opening the door to the possibility of even higher performance gains if DehydraTECH processing was used with nicotine bitartrate dihydrate.

Lexaria will now seek to commercialize DehydraTECH-Nicotine with suitable industry partners based on its clinical and intellectual property advancements.

About Nicotine Study NIC-H22-1
A randomized, double-blind, crossover study design was employed, involving 36 participants who were long time heavy cigarette smokers, smoking at least 10 cigarettes per day. The three nicotine pouches under evaluation were labelled 1, 2, and 3 to maintain blinding. The nicotine pouches compared to Lexaria's DehydraTECH-Nicotine pouch were on! and ZYN brands, with laboratory testing performed to verify 3mg of nicotine in each pouch. Each product had a spearmint flavor and all participants used each product for a predetermined period, with washout periods of 2-7 days in between uses across three separate study visits to minimize carryover effects. Subjective effects, both positive and adverse, were assessed at baseline, 5 minutes, 30 minutes, and 120 minutes using a questionnaire to capture 25 different effects. A battery of different product details as well as adverse events of special interest were also assessed at each study visit. Venous blood for pharmacokinetic (PK) analyses was drawn at baseline and minutes 5, 10, 15, 30, 45, 60, and 120. PK parameters evaluated were area under the curve , maximum plasma concentration , and time to reach the maximum plasma concentration (Tmax). All clinical and laboratory procedures for study NIC-H22-1 were performed entirely by U.S.-based, third-party independent contract service providers.

About DehydraTECH
DehydraTECH is a patented drug delivery formulation and processing platform technology Lexaria has developed and is investigating for a variety of beneficial molecules. 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 into brain tissue, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria has also developed DehydraTECH formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.

About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, 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 35 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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/773195/Lexarias-DehydraTECH-Nicotine-Faster-than-ZYN-and-on

KELOWNA, BC / August 2, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to report its intention to conduct a human clinical study to examine DehydraTECH-CBD for purposes of diabetes control and weight loss.

On March 2, 2023 and June 16, 2023 Lexaria announced that in pre-clinical diabetes study DIAB-A22-1 in obese diabetic-conditioned animals, DehydraTECH-CBD achieved each of the following:

  • Lowered blood glucose levels by 19.9% (p<0.05)
  • Lowered overall body weight by 7% sustained over 8 weeks
  • Witnessed a statistically significant increase in locomotor activity (p<0.05)
  • Lowered triglyceride levels by more than 25% (p<0.007)
  • Lowered blood urea nitrogen levels by 27.9% (p<0.001)

As a result of the very successful pre-clinical results, management of Lexaria has determined it is planning to undertake a human diabetes clinical study to investigate whether any of these improvements are also evidenced in humans. Study design is currently underway by Lexaria, which will be followed by submission to an independent review board to gain necessary approvals.

Lexaria intends to conduct the study at the same medical research hospital in Europe that it has utilized for its recent human clinical hypertension studies, subject to a number of conditions. This cost-effective approach allows Lexaria to complete the most research possible at a fraction of the cost of US-based registered study programs. Additional information including timelines and study details will be released when available.

DehydraTECH-CBD's ability to reduce blood sugar levels in animals is extremely encouraging and warrants additional investigation. According to the Center for Disease Control, managing your blood sugar levels is important to avoid diabetes-related conditions such as vision loss, heart disease, and kidney disease. Limited research, mostly in animal studies, indicates that generic CBD might be ineffective in controlling blood sugars. Using a similar formulation to that used in the pre-clinical animal study, the Company is very interested in discovering whether DehydraTECH-CBD might be effective in blood-sugar control in humans. It is hoped this research will help determine the potential of DehydraTECH-CBD for the treatment of diabetes and its complications.

About DehydraTECH

DehydraTECH is a patented drug delivery formulation and processing platform technology Lexaria has developed and is investigating for a variety of beneficial molecules. 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 into brain tissue, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria has also developed DehydraTECH formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, 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 35 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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/771669/Lexarias-Plans-to-Study-Weight-Loss-and-Diabetes-Control-in-a-Human-Clinical-Study-with-DehydraTECH-CBD

KELOWNA, BC / July 28, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has incorporated a new wholly-owned subsidiary under the name Lexaria Nutraceutical Corp. ("LEXX Nutra").

The establishment of LEXX Nutra is in keeping with Lexaria's overall strategy of maximizing the potential for its patented DehydraTECH Technology in various markets. Lexaria has issued an exclusive perpetual license to LEXX Nutra entitling it to utilize DehydraTECH, or sublicense the use of DehydraTECH, for the purposes of creating consumer packaged goods and/or intermediate ingredients composed of any molecule except those associated with nicotine or cannabis. LEXX Nutra is prohibited from using its license for the manufacture of any pharmaceutical product.

In this regard, the license agreement between the Company and its wholly-owned subsidiary, Lexaria Pharmaceutical Corp. ("LEXX Pharma"), has been amended so that LEXX Pharma's exclusive licensing rights are now focused solely on the manufacture of pharmaceutical products, or sublicensing for the manufacture of pharmaceutical products, composed of any molecule except nicotine-associated molecules.

In addition, Lexaria announced on May 8, 2023 that its human oral nicotine study NIC-H22-1 had completed dosing. Data amalgamation and analysis has since been ongoing, and the Company currently expects to be able to release results within the next two weeks.

Study NIC-H22-1 is a human pharmacokinetic randomized, double blinded, cross-over study conducted in a minimum of 36 human volunteers that are current cigarette smokers. The global market for the oral nicotine pouch category was US$2.33 billion in 2020 and is growing at a rapid CAGR of 30.7% which is expected to reach $21.84 billion in 2027.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, 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 35 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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/770783/Lexaria-Incorporates-New-Subsidiary-for-CPG-Products-and-Updates-Human-Nicotine-Study

  • More countries are banning e-cigarettes as novel oral products gain traction

KELOWNA, BC / July 19, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has been granted a strategically important new patent in the oral nicotine sector by the United States Patent and Trademark Office ("USPTO").

US patent #11,700,875 Compositions and Methods For Sublingual Delivery of Nicotine includes claims for many types of nicotine, including nicotine benzoate, nicotine ditartrate, nicotine citrate, nicotine polacrilex, and many others, for use in sublingual delivery formats like oral pouches. Lexaria's superior DehydraTECH processing and sublingual compositions have now been recognized not only through exceptional scientific study results, but also by the USPTO.

DehydraTECH-nicotine has already shown in multiple sets of animal testing that it can be delivered to the bloodstream up to 10-times to 20-times faster at up to 10-fold higher levels of nicotine into blood plasma from oral absorption than concentration matched controls. Speed of onset is of vital importance to nicotine users.

This US-awarded patent is also progressing as a patent application through other jurisdictions internationally. This US patent award and the international patent applications are supported in part by the superior pharmacokinetic blood plasma data generated by Lexaria in its animal studies conducted from 2017 through 2021. Lexaria considers the work completed by competitors to be substantially inferior when it is limited to indirect theoretical extrapolations of nicotine absorption into the bloodstream and/or subjective commentary from small numbers of people, as opposed to Lexaria's rigorous scientific examinations.

Lexaria's new patent builds nicely upon its growing patent portfolio in the oral nicotine delivery sector including the white pouch category for both sublingual and buccal tissue delivery, together with its previous patent filings specific to nicotine dating back to 2019, as well as its foundational DehydraTECH patent filings dating back to 2016.

The oral nicotine pouch category is of intense interest to Lexaria and the nicotine products industry, and its growth is due in part to its reduced risk health outcomes as noted by the Food and Drug Administration. This delivery method, in the white pouch format specifically, which avoids harmful lung outcomes experienced by smokers or vapers, involves absorption primarily through the buccal and sublingual tissues of the mouth, of purified nicotine that has been separated from most other harmful compounds in the tobacco leaf. The global market for the oral nicotine pouch category was US$4.69 billion in 2022 and is growing at a rapid CAGR of 13.4% and is expected to reach $11.91 billion in 2029.

Meanwhile, at least 37 countries have banned the selling of e-cigarettes, the devices used in vaping. This represents a cumulative population of over 2.3 billion people. Nicotine vaping was originally hoped to help wean people off cigarette use but has had mixed results in doing so, and vaping has also been associated with serious health risks. Nicotine vaping is becoming increasingly controversial and is severely limited in certain countries and was, for instance, recently banned in Australia and is either banned or restricted in many other countries.

Lexaria's DehydraTECH-nicotine is now patent granted for oral nicotine delivery in the U.S., Canada and Australia, and pending in numerous other countries. The white pouch category is one of the fastest growing, tobacco-free alternatives to smoking and vaping. White pouches emit no smoke, odors or vapor that can affect nearby persons and are therefore a superior personal nicotine delivery method.

The dangers of cigarette smoking are well known and result in the death of 7 million people per year. Lexaria's DehydraTECH-powered purified nicotine white pouch formulation contains no tobacco.

Nicotine Plasma Levels (ng/mL) - DehydraTECH vs. Control From Lexaria's NIC-A21-1 Study

Lexaria Bioscience Corp., Wednesday, July 19, 2023, Press release picture

About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, 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 35 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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/768866/Lexaria-Granted-Strategically-Important-New-US-Patent-For-DehydraTECH-Nicotine-Including-Oral-Pouch-Products

DehydraTECH-CBD now featured in eight published, peer-reviewed papers

KELOWNA, BC / June 22, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that its groundbreaking research utilizing DehydraTECH-processed cannabidiol ("DehydraTECH-CBD") has now been published in eight peer-reviewed articles in six different publications.

The most recent paper entitled, "Differences in Plasma Cannabidiol Concentrations in Women and Men: A Randomized, Placebo-Controlled, Crossover Study" was published in June, 2023 in the peer-reviewed International Journal of Molecular Sciences.

"We're proud of the impressive amount of research that our Company has been able to develop through its HYPER-H21 series of clinical studies that has now been assessed by a variety of our respected peers," said John Docherty, President of Lexaria. "Lexaria is establishing itself as one of the world's leaders in the investigation of cannabidiol for the purposes of controlling human blood pressure and we are now focused on launching a FDA-registered IND program to formally investigate DehydraTECH-CBD for hypertension this year."

This recent publication builds on the growing body of peer reviewed literature developed on Lexaria's leading research into the effects of DehydraTECH-CBD upon human health, including hypertension. Additional publications on these findings include the following:

  • In September 2019, "Examination of a New Delivery Approach for Oral Cannabidiol in Healthy Subjects" was published in the journal Advances in Therapy. Also available at PubMed.
  • In June 2022, "Chronic Effects of Effective Oral Cannabidiol Delivery on 24-h Ambulatory Blood Pressure and Vascual Outcomes in Treated and Untreated Hypertension (HYPER-H21-4): Study Protocol for a Randomized, Placebo-Controlled, and Crossover Study" was published in the Journal of Personalized Medicine. Also available at PubMed.
  • In April, 2023, "Trial of a Novel Oral Cannabinoid Formulation in Patients with Hypertension" was published in Pharmaceuticals. Also available at PubMed.
  • "Chronic Effects of Oral Cannabidiol Delivery on 24-h Ambulatory Blood Pressure in Patients with Hypertension" was also published in April, 2023 in Cannabis and Cannabinoid Research. Also available at PubMed.
  • "CBD supplementation reduces arterial blood pressure via modulation of the sympatho-chromaffin system" was additionally published in April, 2023 in Biomedicine & Pharmacotherapy. Also available at PubMed.
  • In June 2023, "The Influence of Oral Cannabidiol on 24-h Ambulatory Blood Pressure and Arterial Stiffness in Untreated Hypertension" was published in Advances in Therapy. Also available at PubMed.
  • "Effects of CBD supplementation on ambulatory blood pressure and serum urotensin-II concentrations in Caucasian patients with essential hypertension" was also published in June, 2023 in Biomedicine & Pharmacotherapy. Also available at PubMed.

The global cardiovascular drugs market was worth US$146.5 billion in 2022 and expected to reach $173.5 billion in 2026 and by geography, North America is the biggest market in the world making US patent protection a necessity in the pursuit of commercial markets. The broad fields of heart disease and of diabetes are emerging as two primary areas of interest for Lexaria, where DehydraTECH-CBD has already generated very positive pilot-study data.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, 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 34 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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/763002/Lexarias-Groundbreaking-Research-into-DehydraTECH-CBD-Published-in-International-Journal-of-Molecular-Science

  • Total of 6 new granted patents received by Lexaria so far in 2023
  • Lexaria now holds 34 granted patents world-wide

KELOWNA, BC / June 20, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received notifications of four new granted patents.

Lexaria has been granted a new Canadian patent under our Patent Family #1: Food and Beverage Compositions Infused with Lipophilic Active Agents and Methods of Use Thereof. This is Lexaria's 18th patent in this Patent Family and our first patent for this Patent Family issued in Canada.

Also in Canada, Lexaria has been granted a new patent under our Patent Family #8: Compositions Infused with Nicotine Compounds and Methods of Use Thereof which was previously announced as "allowed" on April 20, 2023. This is Lexaria's second patent in this Patent Family, following a similar patent issuance in Australia in 2022.

Lexaria has also been granted two new US patents under our Patent Family #21. The first being for Pharmaceutical Compositions and Methods for Treating Hypertension; and the second being for Compositions and Methods for Treating Hypertension, which was previously announced as "allowed" on April 20, 2023. Lexaria points out that one of these patent awards is specifically for pharmaceutical compositions while the other patent award is for non-pharmaceutical compositions, each of which reinforce Lexaria's commercial opportunities in the separate pharmaceutical and consumer markets.

Lexaria believes these two hypertension-related patents could be of particular importance related to the Company's pursuit of utilizing DehydraTECH-CBD in relation to our expected upcoming FDA Investigational New Drug application. The outcomes of our completed HYPER-H21 series of hypertension studies were instrumental in achieving these patent grants. These are Lexaria's first and second granted patents in this Patent Family #21.

The global cardiovascular drugs market was worth US$146.5 billion in 2022 and expected to reach $173.5 billion in 2026 and by geography, North America is the biggest market in the world making US patent protection a necessity in the pursuit of commercial markets.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, 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 34 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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:



View source version on accesswire.com:
https://www.accesswire.com/762138/Lexaria-Receives-New-Patents

  • Blood glucose levels reduced by 19.9% with DehydraTECH-CBD
  • Improvements in kidney function also demonstrated

KELOWNA, BC / June 16, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to report upon additional findings from its diabetes animal study DIAB-A22-1, and also provide updates on two other applied R&D programs.

Diabetes: DIAB-A22-1

As announced on March 2, 2023, Lexaria completed initial testing using DehydraTECH-CBD in its diabetes animal model study that produced three positive outcomes including weight loss in obese diabetic-conditioned animals, together with improved triglyceride and cholesterol levels. Following this, Lexaria undertook a further round of analysis to explore additional study outcomes, including the use of an alternate blood glucose assay detection system with higher detection sensitivity than was used in the initial testing round.

Lexaria Bioscience Corp., Friday, June 16, 2023, Press release picture

Using the Antech hexokinase blood chemistry test panel methodology, Lexaria discovered that blood glucose levels were statistically significantly lowered by 19.9 ± 7% in the obese diabetic-conditioned animals treated with the DehydraTECH-CBD 30 mg/Kg dose (yellow bar above) (*p<0.05) compared to the obese vehicle control animals. This appears to be a new discovery of a property not generally known to be associated with generic CBD treatment.

Kidney function was also evaluated compared to the vehicle control animals by examination of the levels of blood urea nitrogen ("BUN"), creatinine, and assessment of the BUN/creatinine ratio. BUN levels were reduced by 27.9% +/- 5% (***p<0.001) in the obese animals receiving DehydraTECH-CBD. Creatinine levels were also improved with a 16.8% +/-7% increase in the obese animals receiving DehydraTECH-CBD, although this improvement was not statistically significant.

Lexaria Bioscience Corp., Friday, June 16, 2023, Press release picture

Astonishingly, the calculated BUN/creatinine ratio in the obese animals being treated with DehydraTECH-CBD returned to a healthy range nearly equal to that of the lean animals, with a 55.1% +/-16% reduction (*p<0.05) (yellow bars above indicate DehydraTECH-CBD treatment). This may reflect an effect of DehydraTECH-CBD to correct abnormal kidney function in this animal model as another prospective benefit in treating pathological conditions commonly associated with diabetes.

DehydraTECH-CBD's ability to reduce blood sugar levels in animals is extremely encouraging and certainly warrants additional investigation. According to the Center for Disease Control, managing your blood sugar levels is important to avoid diabetes-related conditions such as vision loss, heart disease, and kidney disease. Generic CBD has not, in general, been found to be effective in controlling blood sugars and the Company has not yet discovered whether DehydraTECH-CBD might be effective in blood-sugar control in humans.

Dementia: DEM-A22-1

As announced on November 10, 2022, study DEM-A22-1 was undertaken in thirty-two Long Evans rats using the established novel object recognition test ("NOR"), which is used to assess memory in rodents, in order to investigate whether DehydraTECH-CBD enables any pro-cognitive performance enhancements in this model, potentially of use in dementia treatment.

The findings from this study were generally unremarkable and several unexpected study complications may have muted efficacy distinction ability. Most notably, the aged rats where cognitive impairment was expected to be most obvious did not, in fact, adequately exhibit this impaired tendency, making "improvements" difficult to measure. Also, animals in the high dose DehydraTECH-CBD cohort exhibited reduced locomotor activity, which may have indicated that treatment at this level produced sedative activity, also masking any prospective cognitive improvement. Together, these inconclusive results may point to required study design improvements necessary for a more concrete set of results.

While this research did not produce any notable outcomes, Lexaria now recognizes that previous research by other investigators using CBD in this animal model has required dosing over a much longer duration (over a period of several weeks in order to demonstrate NOR enhancement), than Lexaria has thus far evaluated-. Lexaria will consider this if further testing is considered in future, potentially also including DehydraTECH-processed nicotine, as previously announced, as another agent known to enhance cognitive performance when effectively delivered.

Epilepsy: EPIL-A21-1

As announced on November 29, 2022, Lexaria successfully completed two parts of its EPIL-A21-1 study program designed to evaluate the effectiveness of its DehydraTECH-CBD compared to one of the world's leading anti-seizure medications, Epidiolex®, in reducing seizure activity using an established, vehicle-controlled, acute animal seizure model induced by electrical stimulation ("MES"). The findings from this work appear to demonstrate that DehydraTECH-CBD had effectiveness at lower doses and with greater rapidity than Epidiolex®.

Since that time, Lexaria has also completed a final MES study under its EPIL-A21-1 program designed to establish an ED50 (i.e., the dose required to achieve seizure inhibition in 50% of the animals tested) for DehydraTECH-CBD in this animal model, where ED50 determination is a common performance metric in preclinical animal studies for developmental therapeutics. This ED50 study was designed with an objective to hopefully corroborate Lexaria's prior MES experimental findings. Lexaria is pleased to confirm that the outcome demonstrated that DehydraTECH-CBD was most effective at a dose of 75 mg/Kg, also as previously reported from the initial round of work in this animal model which compared favourably to Epidiolex® that generally required a higher dose of 100 mg/Kg to achieve comparable findings.

About DehydraTECH

DehydraTECH is a patented drug delivery formulation and processing platform technology Lexaria has developed and is investigating for a variety of beneficial molecules. 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 into brain tissue, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria has also developed DehydraTECH formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, 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 30 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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/761594/Lexarias-DehydraTECH-CBD-Lowers-Blood-Glucose-Levels-in-Diabetes-Animal-Study

KELOWNA, BC / June 12, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the appointment of a new Chief Financial Officer.

Effective immediately, Mike Shankman has been appointed as outsourced CFO. Mike is an experienced accounting and finance professional who has held senior positions with companies in the biotechnology, medical devices, and software as a service industries. In his role as a consultant with NOW CFO, one of his current clients is a publicly traded clinical-stage biopharmaceutical company. Former clients include a medical device maker for which Mike collaborated with independent auditors and investment bankers through the completion of an initial public offering. The client began trading on the NASDAQ in 2022.

Mike holds an active license as a Certified Public Accountant and a Masters in Business Administration with a Finance concentration from California State University, East Bay. He lives with his wife in Danville, California. Mr. Chris Bunka will also assume the role of principal financial officer at this time.

Lexaria is grateful to its outgoing CFO, Mr. Greg Downey, for his many contributions and wishes him every success in his future endeavours.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, 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 30 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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/760542/Lexaria-Appoints-New-Chief-Financial-Officer