Lexaria Begins Dosing of Its Second GLP-1 Human Pilot Study

KELOWNA, BC / ACCESSWIRE / May 8, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that human pilot study #2, GLP-1-H24-2, (the "Study") is underway and the first dosing visit for all nine study participants has already concluded.

The Study is a three-arm, crossover investigation that will compare three 7 mg semaglutide dose formulations:

a positive control Rybelsus swallowed tablet (already dosed);

DehydraTECH-semaglutide swallowed capsules;

and for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.

The second DehydraTECH Study arm will use a Rybelsus composition processed with DehydraTECH that is compliant with the U.S. Food and Drug Administration's Inactive Ingredient Database ("FDA IID"), delivered within swallowed capsules. The dosing interval for this Study arm is currently anticipated to complete during mid-June, after the necessary wash-out period for the study participants from the first Study arm.

The acidic environment of the stomach seriously degrades GLP-1 drugs that are swallowed, resulting in exceptionally low blood absorption rates of less than 1% when an absorption technology is not used. For this reason, Lexaria's final DehydraTECH Study arm will investigate an oral dissolvable tablet formulation, also compliant with the FDA IID, with DehydraTECH powered semaglutide from Ryblesus. This will be the first study designed to investigate whether DehydraTECH-enhanced semaglutide can absorb at any level systemically into the sublingual/buccal tissues of the mouth and throat with fewer side effects than from swallowed administration, and with some effective drug delivery into the bloodstream.

In the previously announced human pilot study with 7 volunteers, Lexaria demonstrated superior pharmacokinetic ("PK") oral delivery performance of the DehydraTECH-enhanced GLP-1 drug semaglutide available commercially in the branded product Rybelsus.

About the Study

Design characteristics of the Study are similar in some ways to 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. Nine healthy subjects are expected to be dosed with each test article with roughly a 30-day "washout" interval between each dosing visit.