Lexaria Bioscience Corp. (Nasdaq: LEXX) announced that dosing began on schedule on June 14th for Human Pilot Study #7 (GLP-1-H26-7), which evaluates two oral DehydraTECH-semaglutide compositions against Novo Nordisk’s commercially available Wegovy tablets over a five-week duration. The study is fully funded from existing corporate resources.
The primary objective is to preserve the superior safety and tolerability profiles observed in previous Lexaria GLP-1 studies, such as Human Study #4 (GLP-1-H24-4), while achieving pharmacokinetic performance that matches or exceeds the Wegovy tablet control. Previous single-dose studies incorporating salcaprozate sodium, such as Human Pilot Studies #1 and #2 (GLP-1-H24-1 and GLP-1-H24-2), demonstrated pharmacokinetic performance matching or exceeding the Rybelsus control arm, along with noteworthy safety and tolerability.
The study investigates three separate arms to assess safety, tolerability, and pharmacokinetic properties, comparing SNAC-inclusive DehydraTECH-semaglutide compositions in both tablet and capsule formats to commercially available Wegovy tablets. The study is conducted under fasted pre-dose conditions, consistent with the administration criteria for Novo’s oral semaglutide products. The five-week dosing duration was selected to allow achievement of steady-state concentration levels, where semaglutide blood quantities reach equilibrium between drug input and natural elimination.
This study explores several new DehydraTECH enhancements not previously evaluated. For the first time, Lexaria is using an oral tablet DehydraTECH-semaglutide composition, as opposed to the capsule compositions used in all previous DehydraTECH GLP-1 studies. Novo’s Rybelsus and Wegovy oral semaglutide medications use specially formulated tablets designed to temporarily adhere to the stomach lining and disintegrate, releasing agents in a focal manner that aids in optimizing semaglutide absorption. Lexaria has attempted to mimic and integrate certain physical properties of these tablets to follow established industry standards, thereby increasing the likelihood of subsequent commercial pharmaceutical relationships.
Additionally, both the Lexaria DehydraTECH-semaglutide tablet and capsule test articles will be formulated with SNAC for the first time over a multi-dose, multi-week period in humans. Previous studies that incorporated SNAC were limited by single-dose designs of much shorter duration. The results of this study are expected to be carefully reviewed by the pharmaceutical industry to evaluate potential commercial relationships focused on Lexaria’s proprietary DehydraTECH technology.
The implications of this study are significant for the GLP-1 drug market, which includes blockbuster weight loss and diabetes medications. If Lexaria’s formulations demonstrate comparable or superior pharmacokinetics with improved tolerability, it could offer an alternative to existing oral semaglutide products, potentially expanding patient access and reducing side effects. The successful outcome could also pave the way for licensing deals with major pharmaceutical companies seeking to enhance their oral GLP-1 drug delivery.
