Lexaria Bioscience announces completion of GLP-1-H25-5 study

Lexaria Bioscience (LEXX) announced that human study GLP-1-H25-5 which compared oral capsules of DehydraTECH-liraglutide to injected Saxenda-branded liraglutide has been completed with partial results now available.In distinct clinical human studies, Lexaria has now demonstrated clear reductions in AEs utilizing oral DehydraTECH versions of all three of the major GLP-1 drugs sold in the world today: liraglutide, semaglutide, and tirzepatide. For liraglutide specifically, which is currently sold in genericized versions due to patent expiration, Lexaria is now searching for a pharmaceutical partner interested in utilizing DehydraTECH to support an FDA-registered oral alternative to the current injectable brands within GLP-1. There were a total of 23 AEs in the Saxenda injected liraglutide study arm, as compared to 21 in DehydraTECH-liraglutide oral capsule arm. Of note, 4 of the AEs in the DehydraTECH-liraglutide oral capsule study arm were due to the placement of the peripheral intravenous line used for blood sampling necessary for purposes of conducting the study and, thus, unrelated to the drug treatment; whereas only 1 such AE was recorded in the Saxenda injected liraglutide study arm. With those AEs removed from the analysis, oral DehydraTECH-liraglutide offered a 22.7% reduction in AEs as compared to the injected Saxenda. Particularly noteworthy were the reductions by 67% with respect to nausea and by 31% with respect to gastrointestinal AEs, utilizing oral DehydraTECH-liraglutide as compared to the injected Saxenda. The differences in measurements of blood glucose, insulin and body weight across most time points were not statistically significantly different, with remarkable similarity in many areas and slight differences in others. Weight loss was experienced by 9 out of 10 people in each Study arm and slightly higher in the Saxenda study arm; though weight loss was not a primary goal of this study with the relatively short treatment period. Evaluating the safety and tolerability of the DehydraTECH-liraglutide capsules relative to Saxenda was the primary endpoint of this Study and this objective was successfully met with clear signs of improvement. The two most important strategic objectives of this Study were: To discover whether DehydraTECH processing of liraglutide would work sufficient to potentially allow for an oral version of the drug to be compared to the current injection-only delivery method; and To demonstrate comparable functional results to the injected version, which if successful, could allow for an expedited FDA regulatory pathway known as a 505(b)(2) application that is available when an alternate version of a drug retains certain similar performance characteristics as an earlier-approved version of that same drug. In both these respects, Lexaria feels that the partially completed results from this Study have shown tremendous promise, while also evidencing tolerability advantages from a user appeal perspective.