Lexaria advances human study testing oral semaglutide formulations

Lexaria Bioscience Corp. (NASDAQ: LEXX) submitted requests for ethics approval for Human Pilot Study #7, which will evaluate two oral DehydraTECH-semaglutide compositions against Novo Nordisk's Wegovy tablets.

The company completed final laboratory tablet composition work and commercial-scale manufacturing for the test articles. Third-party quality-control testing is currently underway. Lexaria anticipates completing ethics approval, quality-control testing and packaging by early June, with dosing expected to begin in mid-June.

The five-week parallel group study will investigate three separate arms to assess safety, tolerability and pharmacokinetic properties. The study will compare salcaprozate sodium-inclusive DHT-sema tablet and capsule formulations to commercially available Wegovy tablets under fasted pre-dose conditions.

The study introduces two enhancements to Lexaria's DehydraTECH technology. For the first time, the company will use an oral tablet DHT-sema composition designed to mimic certain properties of Novo Nordisk's tablet delivery system. The tablets are formulated to temporarily adhere to the stomach lining and release agents to optimize semaglutide absorption.

Both tablet and capsule test articles will be formulated with salcaprozate sodium and evaluated over a multi-dose, multi-week period for the first time. The five-week duration is expected to be sufficient to reach steady-state drug concentrations in the body. Previous DHT-sema human studies were limited to single-dose designs of shorter duration.

The study is funded from existing corporate resources, according to the company's press release.

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