Lexaria Awards Contract For Next GLP-1 Human Pilot Study

• First-ever dissolvable DehydraTECH-GLP-1 oral dose formulation to be tested
• Rybelsus semaglutide will act as the positive control

KELOWNA, BC / ACCESSWIRE / March 7, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has hired a contract research organization ("CRO") to perform the Company's second DehydraTECH-powered glucagon-like peptide 1 ("GLP-1") human pilot study #2 (the "Study").

The Study will be a randomized, crossover, placebo-controlled investigation that will compare three dose formulations each at a 7 mg semaglutide dose:

• a positive control Rybelsus swallowed tablet;
• DehydraTECH-semaglutide swallowed capsules; and,
• for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.

Semaglutide swallowed into the stomach/intestine absorbs into the bloodstream at an exceptionally low rate typically at less than 1%, when it does not use any absorption technology because, in part, the acidic environment of the stomach is known to seriously degrade GLP-1 drugs.

"DehydraTECH has previously shown an ability to improve delivery of certain drugs destined for the bloodstream, through the buccal/sublingual tissues of the mouth and throat," said Chris Bunka, CEO of Lexaria Bioscience Corp. "If this new Study is successful in demonstrating efficacy and safety, the potential for a new era in GLP-1 delivery without the need for painful injections or stomach-upsetting tablets, could be within reach."

Manufacturing of the test articles for this Study is anticipated to be completed within 30 days. Independent Review Board approval is required before the Study can commence, and the Company will provide our next update when dosing has begun.

CORRECTION

In Lexaria's press release of March 4, we described an upcoming animal study as having an 8-week duration. That was a typographical error: the correct animal study duration is 12-weeks.

About the Study

Many design characteristics of the Study will be fundamentally the same as in Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles will be compound formulated using crushed Rybelsustablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, and blood glucose levels. Blood samples will be taken multiple times during the first 10 hours post dosing; a final blood draw will be taken 24 hours after dosing; and, a standardized meal will be fed to the test subjects at a point in time after dosing. Eight healthy subjects are expected to be dosed with each test article following a cross over study design across three study visits.