Ethics Board Approval Received for DehydraTECH-tirzepatide GLP-1 Study-Arm

Rhea-AI Summary

Lexaria Bioscience (NASDAQ:LEXX) has received lead clinical site human research ethics committee (HREC) approval for the 5th study arm of its Phase 1b, 12-week chronic study GLP-1-H24-4 in Australia. This follows the November 13, 2024 approval for the first 4 arms. The study includes five arms: DehydraTECH-CBD capsules, DehydraTECH-semaglutide capsules, DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules, Rybelsus® tablets, and DehydraTECH-tirzepatide capsules.

The study commenced with First Patient First Dose in December 2024. Additional HREC approval for other clinical sites is pending and expected soon. The study aims to evaluate the potential enhancement of GLP-1 drugs through Lexaria's DehydraTECH delivery technology, focusing on oral administration rather than injections.

Positive

• Study includes both semaglutide and tirzepatide, covering over 90% of global GLP-1 market
• Study progressing on schedule with First Patient First Dose achieved in December 2024
• All lead clinical site approvals received for all 5 study arms

Negative

• Additional HREC approvals still pending for other clinical sites

Insights

Clinical Research Analyst

The ethics board approval for Lexaria's tirzepatide study arm marks a pivotal development in their clinical program, particularly noteworthy for a 25M market cap company. The study's scope is remarkably ambitious, targeting the two dominant GLP-1 medications that collectively represent over 90% of the global market.

The trial's design is particularly sophisticated, incorporating multiple arms that will evaluate:

• Individual performance of DehydraTECH-enhanced semaglutide and tirzepatide
• Synergistic effects with CBD
• Direct comparison against the established Rybelsus formulation

The oral delivery aspect is important - current tirzepatide (Mounjaro) and semaglutide (Ozempic) treatments require injections, while Rybelsus (oral semaglutide) has bioavailability. If DehydraTECH can enhance the oral absorption of these compounds, it could revolutionize the treatment paradigm for millions of patients and potentially capture a significant portion of the rapidly growing GLP-1 market.

The efficient progression from November's initial approvals to the current comprehensive study authorization demonstrates strong operational execution. The December 2024 initiation of patient dosing aligns with projected timelines, suggesting well-managed regulatory and clinical processes.

However, investors should note that success in early-phase trials doesn't guarantee commercial viability. Key challenges include:

• Demonstrating bioequivalence or superior bioavailability compared to existing formulations
• Achieving consistent absorption profiles across patient populations
• Navigating potential intellectual property challenges from established pharmaceutical companies

5^th study arm in 12-week Phase 1b Study receives lead clinical site approval

KELOWNA, BC / ACCESS Newswire / February 24, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has received lead clinical site human research ethics committee ("HREC") approval that was required before dosing can begin in the 5^th study arm of the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study") in Australia.

This news complements similar news issued on November 13, 2024, when initial lead clinical site HREC approval was received for the first 4 arms of the Study. The Company is pleased to have received all of the necessary lead clinical site approvals so quickly. Additional HREC approval is still pending for the other clinical sites, which is expected soon.

The Study is progressing with both patient recruitment and dosing. The milestone of First Patient First Dose occurred in December 2024 as planned. As a reminder, the 5 Study arms are as follows:

Arm 1 - DehydraTECH-CBD capsules

Arm 2 - DehydraTECH-semaglutide capsules

Arm 3 - DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules

Arm 4 - Rybelsus® tablets (positive control)

Arm 5 - DehydraTECH-tirzepatide capsules (with the newly received HREC approval)

"The ability to study two GLP-1 drugs - semaglutide and tirzepatide - in a single study that together comprise well over 90% of the global GLP-1 market is truly a remarkable achievement for a company of our size," said Richard Christopher, CEO of Lexaria Bioscience Corp. "Lexaria's ability to utilize our patented DehydraTECH delivery technology to potentially enhance performance characteristics of these drugs, along with our very own DehydraTECH-CBD, all the while utilizing oral dosing as opposed to injections, is a unique opportunity."

Further Study updates will be provided as and when available.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients enter the bloodstream through oral delivery. Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to 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.

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 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

SOURCE: Lexaria Bioscience Corp.

View the original press release on ACCESS Newswire

FAQ

What are the 5 study arms in Lexaria's (LEXX) Phase 1b GLP-1 trial?

The study includes DehydraTECH-CBD capsules, DehydraTECH-semaglutide capsules, DehydraTECH-semaglutide with CBD capsules, Rybelsus® tablets, and DehydraTECH-tirzepatide capsules.

When did Lexaria (LEXX) begin dosing patients in its GLP-1 Phase 1b study?

The First Patient First Dose occurred in December 2024.

What percentage of the global GLP-1 market do the drugs in LEXX's study represent?

The two GLP-1 drugs being studied (semaglutide and tirzepatide) together comprise over 90% of the global GLP-1 market.

What is the duration of Lexaria's (LEXX) Phase 1b GLP-1 study?

The study is a 12-week chronic study conducted in Australia.