Arizona Tribune - Lexaria's Phase 1b GLP-1 Study Achieves Important "Last Patient Last Visit" Milestone

"We are delighted that this important milestone has been achieved on schedule, concluding all patient dosing and clinical testing in our Study," said John Docherty, Lexaria's President and CSO. "Study work continues with full sample and data analyses currently underway in order to reach our late 2025 final reporting objective."

The Study CRO is actively managing the laboratory analysis phase of the work, where thousands of samples collected during the Study are being carefully processed, analysed, and recorded into an extensive database recording system. Lexaria is blinded to that data until the database work has been completed.

Lexaria previously released partial 8-week positive interim results from the Study with encouraging results aligned with its primary study endpoint. These interim results were tracking very nicely from a safety and tolerability perspective relative to the Rybelsus® control arm of the Study; most notably in terms of reductions in the incidence of gastrointestinal adverse events.

About The Study
The Study was conducted with 24-25 overweight, obese, pre- or type 2 diabetic patients in each of the 5 Study Arms (N=126), of which 4 arms evaluated various DehydraTECH formulations with the 5^th being the Study control arm. All doses were administered daily by oral tablet or capsule - there were 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 utilized a proprietary, patented DehydraTECH-CBD formulation. As a reminder, Lexaria has earlier received a Food and Drug Administration no-objection letter to proceed with a separately devised Phase 1b human clinical study to examine the utility of DehydraTECH-CBD in the pursuit of hypertension relief.

Arms 2 and 3 of the Study used DehydraTECH-processed pure semaglutide. Arm 2 examined DehydraTECH-semaglutide on a stand-alone basis, while Arm 3 examined DehydraTECH-semaglutide in combination with DehydraTECH-CBD. These arms were compared to the Study control arm (Study Arm 4) which used Rybelsus® tablets (semaglutide) that contains Novo Nordisk's® proprietary salcaprozate sodium ("SNAC") technology.

Study Arm 5 evaluated the 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 12-week Study duration in the Study population?

• Does DehydraTECH-(pure) semaglutide match or outperform Rybelsus®-semaglutide with its proprietary SNAC technology in measures of blood sugar control, weight loss, and/or reduced side-effects?

• Does DehydraTECH processing enhance real world outcomes such as weight loss, blood sugar control and/or reduction of side-effects 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 final results of the Study when available, which is currently projected to be during 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 50 patents granted and additional 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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

View the original press release on ACCESS Newswire

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