Registered Phase-1b 12-week study investigating safety, diabetes control, and weight loss
KELOWNA, BC / ACCESS Newswire / April 3, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to provide this progress update on its Phase 1b, 12-week chronic study GLP-1-H24-4 (the "Study") underway in Australia.
Enrollment of patients for all 5 Study arms has now been completed on schedule. Participation interest in the Study was extremely high, so the Study overenrolled entering a total of 24 patients per Study arm versus the original target of 20. Completion of enrollment signifies the important "last patient in" ("LPI") clinical study milestone, meaning that treatment of all patients is expected to be completed roughly twelve weeks from now, to be followed by the series of patient sample analyses, data compilation, analysis and reporting.
"Lexaria is pleased to have reached LPI enrollment completion," said John Docherty, President and Chief Scientific Officer of Lexaria Bioscience Corp. "Dosing is progressing nicely and, at this point, we are expecting the Study to complete on schedule."
About The Study
The Study is underway with 24 overweight, obese, pre- or type 2 diabetic patients for each of the 5 Study Arms, four of which are evaluating DehydraTECH-semaglutide, DehydraTECH-tirzepatide, and DehydraTECH-cannabidiol ("CBD"), with Study Arm 4 being the control arm. All drugs are being administered daily by oral tablet or capsule - there are no drug injections involved in this Study as Lexaria is promoting a change in the standard of care, moving away from injections and instead embracing oral DehydraTECH delivery.
Arm 1 of the Study is utilizing a proprietary, patented DehydraTECH-CBD formulation. Our 2022 diabetes animal study DIAB-A22-1, utilizing DehydraTECH-CBD evidenced weight loss of 7% and reduced blood glucose levels of 19.9%+/-7% (p<0.05) during a multi-week rodent study without the addition of any GLP-1 drugs. Lexaria is looking forward to discovering in humans whether DehydraTECH-CBD studied alone, or together with DehydraTECH-semaglutide as is being explored in Arm 2, might offer some benefit of improved weight loss and/or reduced side effects as compared to Rybelsus® alone.
Arms 2 and 3 of the Study are using DehydraTECH-processed pure semaglutide and will be compared to Study Arm 4 which will use Rybelsus® tablets (semaglutide) that contains Novo Nordisk's® proprietary salcaprozate sodium ("SNAC") technology. It is a world-first that pure semaglutide processed with DehydraTECH technology without SNAC will be compared directly to SNAC-enabled Rybelsus® in a multiple week human study.
Study Arm 5 will evaluate performance of DehydraTECH-tirzepatide, pursuant to the positive findings previously achieved and released for Human Pilot Study #3 (GLP-1-H24-3).
In its first-ever GLP-1 study in humans reported in January 2024, Lexaria discovered that DehydraTECH processing of Rybelsus®-branded semaglutide, after a single dose, improved blood sugar control and reached higher levels of semaglutide measured in blood, than did Rybelsus® alone. Also, in rodent study work reported in October 2024, Lexaria was pleased to see comparable performance of DehydraTECH-semaglutide without SNAC to DehydraTECH-processed Rybelsus® formulations including SNAC; which Lexaria previously reported may be due to DehydraTECH preserving similar molecular properties in the gut for ingested semaglutide which has been shown to be integral to SNAC-enabled semaglutide gut absorption.
Lexaria has several important objectives for this Study:
Is DehydraTECH processed CBD, semaglutide, and/or tirzepatide safe over the Study duration in the Study population?
Does DehydraTECH-(pure) semaglutide outperform Rybelsus®-semaglutide with its proprietary SNAC technology in measures of blood sugar control or weight loss?
Does DehydraTECH processing enhance real world outcomes such as weight loss and blood sugar control over the Study duration?
Does DehydraTECH processing of pure semaglutide evidence reduced side effects during daily dosing for 12 weeks, as DehydraTECH processing of Rybelsus® seemed to achieve in a prior human study utilizing one single daily dose?
Lexaria expects to release the results of the Study when available, which is currently projected to be during in the fourth quarter of 2025.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and 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 48 patents granted and additional patents pending worldwide. For more information, please visit www.lexariabioscience.com.
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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 ir@lexariabioscience.com Phone: 250-765-6424, ext 202
