Lexaria Awards Contract for Third Human GLP-1 Study

Kelowna, BC – Lexaria Bioscience (Nasdaq:LEXX, LEXXW) has announced the commencement of a groundbreaking human pilot study focused on evaluating an innovative oral delivery method for tirzepatide. This study will be managed by a contract research organization (CRO) and aims to compare the efficacy and tolerability of DehydraTECH-processed tirzepatide in a capsule form against the currently available injectable form, Zepbound®, produced by Eli Lilly.

Study Overview
The study, designated as Human Pilot Study #3, will adopt a randomized, crossover design involving two arms: one will administer DehydraTECH-processed tirzepatide capsules, and the other will employ injected Zepbound® tirzepatide. The central objective is to determine if the orally-delivered tirzepatide can successfully be absorbed into the bloodstream and to measure its pharmacokinetics, human tolerability, and impact on blood sugar levels.

Tirzepatide, a dual-action GLP-1 and GIP peptide, is currently only available in injectable form. Lexaria’s study aims to investigate whether the oral delivery method, facilitated by its DehydraTECH technology, can provide a feasible alternative. Blood samples will be collected at multiple intervals during the first 10 hours post-dosing, with a final sample taken 24 hours after dosing. Additionally, participants will consume a standardized meal after dosing to further assess the compound's effects.

Significance of the Study

Chris Bunka, CEO of Lexaria Bioscience Corp., emphasized the potential significance of this study. Oral tablets of GLP-1 drugs have often resulted in adverse side effects. This study aims to demonstrate that DehydraTECH-processed tirzepatide can achieve better tolerability and measurable drug levels in the bloodstream when delivered orally. This research marks Lexaria’s inaugural exploration of the tirzepatide molecule and any positive results could have significant implications for the development of more patient-friendly tirzepatide delivery methods.

Manufacturing and Regulatory Approvals

The preparation of test articles for this study is expected to be completed within 30 days. The study will commence once it receives approval from an Independent Review Board (IRB). Lexaria will provide further updates upon IRB approval.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp. is known for its patented DehydraTECH drug delivery technology, which enhances the absorption of active pharmaceutical ingredients when administered orally. Since 2016, Lexaria has been developing this technology to improve the bioavailability of various compounds, including those aimed at crossing the blood-brain barrier, which is crucial for treating central nervous system disorders.

Lexaria operates its own licensed research lab and boasts an extensive intellectual property portfolio, with 43 granted patents and numerous pending applications worldwide. The company continues to prioritize innovation in drug delivery methods to enhance patient outcomes.

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