Lexaria Awards Contract For Third GLP-1 Human Pilot Study

First-ever DehydraTECH-processed tirzepatide from Zepbound to be tested in a swallowed oral format

KELOWNA, BC / ACCESSWIRE / May 23, 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 human pilot study #3, (the "Study") which will evaluate a dual action GLP-1 (glucagon-like peptide) + GIP (glucose-dependent insulintropic peptide).

The Study will be a randomized, crossover investigation that will compare injected tirzepatide (Zepbound by Eli Lilly) to a compound formulated, DehydraTECH-processed tirzepatide derived from Zepbound and rendered into a capsule to be swallowed. There are two study arms:

• DehydraTECH-tirzepatide swallowed capsules; and,
• Injected Zepbound tirzepatide by Eli Lilly.

Tirzepatide is currently available only in its injected form, Zepbound, by Eli Lilly - it is not available in an FDA-approved oral dosage format. The Study will evaluate whether DehydraTECH-processed tirzepatide, when taken orally, offers any absorption into the human bloodstream and, if so, how much. Human tolerability, pharmacokinetics and blood sugar levels will all be recorded and evaluated in this Study.

"Many GLP-1 drugs have produced unpleasant side effects, especially when dosed through oral tablets," said Chris Bunka, CEO of Lexaria Bioscience Corp. "Lexaria's latest study in an oral capsule hopes to evidence improved tolerability while also producing measurable quantities of drug in blood. This will be Lexaria's first-ever work with the tirzepatide molecule and, as such, any noteworthy delivery of tirzepatide through oral delivery could be a significant finding."

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

About the Study

Many design characteristics of the Study, also referred to as Study GLP-1-H24-3, are similar to Lexaria's initial GLP-1 human pilot study. The DehydraTECH-tirzepatide test articles will be compound formulated using Zepbound, strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of tirzepatide, 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 two study visits.