Lexaria’s Human GLP-1 Study #5 Receives Independent Review Board Approval

January 15, 2025 at 09:20 AM EST

Positive results in a recent animal study strongly supports first-ever human investigation for DehydraTECH-liraglutide in an oral capsule format

KELOWNA, BC / ACCESSWIRE / January 15, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce that it has received the necessary independent ethics board approval required for its contract research organization ("CRO") to begin to implement and execute human pilot study GLP-1-H25-5 (the "Study"). The Study will compare an oral version of liraglutide, formulated from the DehydraTECH-processing of Saxenda® ("DehydraTECH-liraglutide") to the conventional injected liraglutide (Saxenda®).

Lexaria has already demonstrated success in DehydraTECH processing for superior human oral delivery performance of the world's two most widely used GLP-1 drugs; semaglutide (Novo Nordisk®) and tirzepatide (Eli Lilly). Liraglutide, also owned by Novo Nordisk®, is the world's 3^rd most popular glucagon-like peptide-1 ("GLP-1") or glucose-dependent insulinotropic ("GIP") weight loss/diabetes drug on the market today. Lexaria has previously investigated liraglutide in a 12-week rodent study, as reported on November 20, 2024, in which DehydraTECH- liraglutide - administered orally - demonstrated a 5.88% weight reduction and 11.54% blood sugar reduction compared to baseline, outperforming the comparably dosed positive control semaglutide product, Rybelsus®, also tested in that study.

Liraglutide is currently sold only in an injectable form under the brand names Saxenda® and Victoza®, both manufactured by Novo Nordisk®. Despite the launch of a genericized injected version of liraglutide by Teva® during 2024, liraglutide sold by Novo Nordisk® under the brand name of Saxenda® still generated US$849 million in the first half of 2024; and under the brand name Victoza®, generated an additional US$1.6 billion in recent annual revenue.

The Study is expected to be conducted with 8-10 healthy volunteers with the goals of demonstrating safety and pharmacokinetic performance in humans utilizing orally dosed DehydraTECH-liraglutide. If the Study results are positive, it could support a decision to investigate oral DehydraTECH-liraglutide in a future Phase I registered trial.

"All three of the GLP-1 and GIP drugs that Lexaria has tested during the last fifteen months have delivered successful results," said Richard Christopher, CEO of Lexaria. "We are establishing our technology as perhaps the most effective drug delivery technology in the world to date, for weight loss drugs such as GLP-1."

Approved for use by diabetics to control blood sugar, liraglutide has also evidenced an ability to slow cognitive decline in a Phase 2b clinical trial, and reduce shrinkage of those areas of the brain that control memory, learning, and language by nearly 50% as compared to placebo.

The Study protocol design is complete and a clinical test site has been determined. Further updates will be provided when the first dosing begins.

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.

View the original press release on accesswire.com

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Lexaria’s Human GLP-1 Study #5 Receives Independent Review Board Approval

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