American Marconi Wireless News - Lexaria's Human Study GLP-1-H26-7 Has Begun Dosing on Schedule

Lexaria is seeking to preserve the superior safety and tolerability profiles evidenced in its previous glucagon-like peptide-1 ("GLP-1") studies such as Human Study #4 (GLP-1-H24-4), combined with pharmacokinetic ("PK") performance that matches or exceeds the Wegovy® tablet control. Previous Lexaria salcaprozate sodium ("SNAC")-inclusive DHT-sema single dose studies such as Human Pilot Studies #1 and #2 (GLP-1-H24-1 and GLP-1-H24-2) evidenced PK performance that matched or exceeded the Rybelsus® control arm and 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.

The Study is investigating three separate arms to assess safety & tolerability as well as PK properties that will compare SNAC-inclusive, DHT-sema compositions formulated in both tablet and capsule formats to commercially available Wegovy® tablets. The Study is being conducted under fasted pre-dose conditions similar to the advised administration criteria of Novo's oral semaglutide products. The 5-week dosing duration was selected in order to allow for achievement of steady state concentration levels, meaning that the semaglutide blood quantities in each arm will be expected to reach an equilibrium level that balances drug input with natural bodily elimination.

The Study is exploring 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 administered in all our previous DehydraTECH™ GLP-1 studies. Novo's Rybelsus® and Wegovy® oral semaglutide medications 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 semaglutide into the human body. For the first time ever, Lexaria has attempted to mimic and integrate certain physical properties of the Rybelsus® and Wegovy® SNAC-inclusive tablet delivery modality into its DHT-sema tablets to follow established industry standards and thereby 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 will be 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. As noted above, Human Pilot Studies #1 and #2 (GLP-1-H24-1 and GLP-1-H24-2), conducted in 2024 and 2025 which incorporated SNAC (but did not use tablets), were limited by single-dose study designs and therefore of much shorter duration.

The Study is fully funded from existing corporate resources.

About Lexaria Bioscience Corp. & DehydraTECH™

DehydraTECH^TM 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^TM 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 66 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

Ch.Kahalev--AMWN