Lexaria Receives Independent Review Board Approval to Begin Human Pilot Study #3

First-ever DehydraTECH-processed tirzepatide from Zepbound^® to be tested in a swallowed oral format

KELOWNA, BC / ACCESSWIRE / September 27, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms is pleased to announce that approval has been received from an independent review board, for human pilot study #3 (the “Study”), investigating a DehydraTECH-processed version of the dual action GLP-1 (glucagon-like peptide) + GIP (glucose-dependent insulinotropic peptide) tirzepatide in an oral dose format.

Subject recruitment will begin shortly and the Company will announce as soon as the first dosing has begun, currently expected in late October. Lexaria anticipates the final doses in the study to be administered in late November.

The Study will be conducted in up to 10 healthy volunteers and will study a single injected dose of Zepbound^® (tirzepatide) monitored over a 7-day duration, compared to 7 consecutive days of daily oral dosing of DehydraTECH-processed Zepbound^®.

Tirzepatide is currently approved for use in the USA under the brand names Zepbound^® and Mounjaro,_® owned by Eli Lilly™. These two brands combined are expected to generate approximately $15 billion in revenue in 2024.

Tolerability (side effects), blood absorption levels (pharmacokinetics or “PK”), and blood sugar control will all be evaluated in this Study. The DehydraTECH compositions for this Study will be compound-formulated using commercially available Zepbound^® injectable formulation as the tirzepatide input material.

In two previous human pilot studies, Lexaria has evidenced that processing of semaglutide (sold by Novo Nordisk^® under the brands Rybelsus^®, Ozempic^®, and Wegovy^®) with DehydraTECH and administered in an oral format, shows improvements in absorption rates and a reduction in both blood sugar and in adverse events, as compared to the Rybelsus^® tablet. In pilot Study #3 referred to today, Lexaria is hopeful of evidencing meaningful absorption rates of tirzepatide in a swallowed oral format, which is not available in the market today since it is currently administered only by injection.

In a separate development, Lexaria also announces that the contract research organization (“CRO”) hired by Lexaria to perform the Company’s 12-week study GLP-1-H24-4 that will evaluate various DehydraTECH-GLP-1 formulations and other treatments, has submitted the required package of information for its own Human Research Ethics Committee review. This study, expected to be regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration, is expected to begin first-in-patient dosing this winter, in Australia. Lexaria will provide an update once ethics board approval in this instance is also received.

About the Study

Many design characteristics of the Study, also referred to as Study GLP-1-H24-3, are similar to Lexaria’s initial GLP-1 human pilot study #1. The DehydraTECH-tirzepatide test articles will be compound formulated using Zepbound^®, strictly for research purposes, dosed to the subjects under fasted conditions. The Study is designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose levels. Blood samples will be taken multiple times during the first 10 hours post dosing; a final blood draw will be taken 24 hours after dosing; and, a standardized meal will be fed to the test subjects at a point in time after dosing. Up to ten healthy subjects are expected to be dosed with each test article following a cross over study design across two study visits.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.’s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 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 46 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 to 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
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.