Monthly Archives: August 2023

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.

• 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:

"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.

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.

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.