Arizona Tribune - Lexaria Receives Independent Review Board Approval to Begin Human Pilot Study #7

"Lexaria is delighted to have received the independent ethics review board approval so quickly," said Richard Christopher, CEO of Lexaria Bioscience. "Lexaria is looking for this Study to provide the positive outcomes necessary to support commercial collaboration within the pharmaceutical industry related to Lexaria's demonstrated improvements in delivering oral GLP-1 drugs in real-world environments."

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-H25-4), combined with pharmacokinetic ("PK") performance that matches or exceeds the Wegovy^® tablet control over a 5-week period. 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.

Laboratory tablet composition work and commercial-scale manufacturing for the DHT-sema test articles for the Study have been performed. Third-party independent lab quality-control ("QC") testing of those test articles is currently underway and is expected to be complete in early June. Packaging of all the test articles suitable for the Study will be undertaken in parallel with this.

The design of the Study is now complete: a five-week parallel group design, investigating three separate arms to assess safety & tolerability and PK properties that will compare SNAC-inclusive DHT-sema tablet and capsule formulations to commercially available Wegovy^® tablets. The Study will be conducted under fasted pre-dose conditions.

The 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 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 the Rybelsus^®/Wegovy^® SNAC-inclusive tablet delivery modality into its DHT-sema tablets to 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. 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; therefore, of much shorter duration.

Lexaria currently expects 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

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