Arizona Tribune - Lexaria Updates Progress on Human Study #7

Submissions have now been entered to formally request the required ethics approval from an independent review board. Final laboratory tablet composition work and commercial-scale manufacturing for the DHT-sema test articles for the Study have been completed with third-party independent lab quality-control ("QC") testing of such test articles currently underway. It is anticipated that receipt of ethics approval, completion of QC testing and packaging of the qualified test articles (the "Pre-Dosing Tasks") will occur by early June.

The design of this Study is complete, subject to any modifications which may or may not be required by the ethics reviewers. The Study is planned to be a five-week parallel group design, investigating three separate arms to assess safety & tolerability and pharmacokinetic ("PK") properties that will compare salcaprozate sodium ("SNAC")-inclusive DHT-sema tablet and capsule formulations to commercially available Wegovy^® tablets. The Study will be conducted under fasted pre-dose conditions. Lexaria hopes to preserve the superior safety and tolerability profiles as evidenced in previous Lexaria GLP-1 studies such as Human Study #4 (GLP-1-H25-4), combined with PK performance that matches or exceeds that of the commercial oral tablet as also evidenced in previous Lexaria SNAC-inclusive DHT-sema studies such as Human Studies #1 and #2 (GLP-1-H24-1 and GLP-1-H24-2; which, incidentally, also evidenced noteworthy safety and tolerability profiles).

The results of this Study are expected to be carefully reviewed by the pharmaceutical industry in order to evaluate the possibility of entering into commercial relationships focused on Lexaria's proprietary DehydraTECH technology.

What's New?

This Study explores several new DehydraTECH enhancements not previously evaluated, which include but are not limited to the following two main improvements:

1. First, an oral tablet DHT-sema composition will be used by Lexaria for the first time, as opposed to only the capsule compositions included in all our previous DHT glucagon-like peptide-1 ("GLP-1") studies. Novo Nordisk's^® Rybelsus^® and Wegovy^® oral semaglutide medications both use specially formulated tablets designed to temporarily adhere to the stomach lining and disintegrate and dissolve releasing agents in a focal manner that aids in optimizing absorption of the active ingredient - semaglutide - into the human body. For the first time ever, Lexaria has attempted to mimic and integrate certain properties of this Rybelsus^®/Wegovy^® tablet delivery modality into its DHT-sema tablets. Lexaria believes this may increase the likelihood of subsequent commercial pharmaceutical relationships.

2. Second, both the Lexaria DHT-sema tablet and capsule test articles will be formulated with SNAC, which will be the first time these formulations are evaluated over a multi-dose, multi-week time period in humans. The five-week dosing duration of the Study is expected to be long enough to reach so-called steady-state, which is when drug concentrations in the body reach a constant concentration. Earlier DHT-sema human pilot studies GLP-1-H24-1 and GLP-1-H24-2, as noted above, that Lexaria conducted in 2024 and 2025 that also used SNAC (but did not use tablets), were limited by single-dose study designs; therefore, of much shorter duration. Novo Nordisk's^® branded Rybelsus^® and Wegovy^® semaglutide-based products are both formulated with SNAC.

Lexaria will update its stakeholders once the Pre-Dosing Tasks have been achieved. Based on the expected timelines, Lexaria anticipates dosing to begin in mid-June. The Study is fully funded from existing corporate resources.

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 65 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 intended use of proceeds from the offering and 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, market and other conditions, 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

P.Smith--AT