Lexaria signs contracts for human study of oral semaglutide formulation
Lexaria Bioscience Corp. (NASDAQ: LEXX) announced it has signed contracts with a contract research organization to conduct Human Pilot Study #7, which will evaluate two oral DehydraTECH-semaglutide compositions against commercially available Wegovy tablets.
The company is preparing submissions to obtain ethics approval from an independent review board. The study design is expected to be a 5-week parallel group investigation with three separate arms to assess safety, tolerability and pharmacokinetic properties under fasted conditions.
The study will test both tablet and capsule formulations containing salcaprozate sodium, comparing them to Wegovy tablets. This marks the first time Lexaria will use an oral tablet composition for its DehydraTECH-semaglutide formulation, having previously used only capsule compositions in glucagon-like peptide-1 studies.
The tablet formulation attempts to mimic certain properties of Novo Nordisk's Rybelsus and Wegovy tablets, which are designed to temporarily adhere to the stomach lining and release active ingredients in a targeted manner. Both test formulations will include SNAC, which is also used in Novo Nordisk's branded semaglutide products.
The 5-week duration is intended to reach steady-state drug concentrations in the body. Previous Lexaria studies using SNAC were limited to single-dose designs of shorter duration.
Lexaria will provide updates once ethics board approval is obtained and patient recruitment can begin. The study is funded from existing corporate resources.
DehydraTECH is Lexaria's drug delivery platform technology designed to improve oral drug absorption. The company holds 65 granted patents with additional patents pending worldwide.
