Lexaria Bioscience says second GLP-1 human pilot study shows zero adverse events

Lexaria Bioscience announces that tolerability and additional pharmacokinetic results from human pilot study #2, GLP-1-H24-2, have been received. Lexaria’s DehydraTECH-processed Rybelsus capsules demonstrated superior tolerability in delivering the GLP-1 drug semaglutide versus commercially available Rybelsus. We were pleased to find that none of the 9 people taking the DehydraTECH-processed Rybelsus swallowed as a capsule experienced any adverse events whatsoever. However, of the 9 human volunteers in the Study taking the Rybelsus tablet, 6 of them experienced mild adverse events. Five of those same 6 people experienced mild adverse events from taking the dissolvable oral mouth-melt format of DehydraTECH-processed Rybelsus. These tolerability findings nicely build upon the those from Lexaria’s previous human pilot study #1, GLP-1-H24-1, which also showed the DehydraTECH-processed Rybelsus capsules to be generally better tolerated than the Rybelsus tablets that demonstrated instances of moderate nausea or diarrhea. Combined with the 7 people involved in Lexaria’s first human pilot study examining DehydraTECH processing of semaglutide capsules, a total of 16 people have now been dosed with comparable DehydraTECH-processed semaglutide capsules and Rybelsus tablets. Of those 16 people, 13 or 81%, experienced mild or moderate side effects with the Rybelsus tablet and only 7 people, or 44%, experienced only mild side effects with the Rybelsus that was processed with DehydraTECH and administered via capsules. Most of the side effects experienced in all cases were of a gastrointestinal nature including belching, diarrhea and nausea that are commonly associated with GLP-1 drugs, although intensity was lower in all instances with the DehydraTECH-processed Rybelsus capsules in pilot study #1 or absent altogether in the present Study. The continuing evidence of decreased adverse events with the DehydraTECH-processed Rybelsus capsules compared to commercially available Rybelsus tablets is encouraging. Other reports have noted that Rybelsus generally produces slightly higher incidences of several common side effects as compared to the injectable product Ozempic, which outsells Rybelsus by a factor of almost five-fold. DehydraTECH’s ability to improve oral tolerability could, in future, however, help to drive increased use of oral GLP-1 product formats, if proven definitively through thorough registered clinical testing. Lexaria also reports that the third arm of the Study that evaluated a DehydraTECH-processed Rybelsus formulation as an in-mouth dissolvable tablet also showed some promise from a conceptual perspective. Across the 18 blood draws from the 20-minute mark until the 24-hour mark in the Study, the average blood concentration level of the Rybelsus tablet was 3.93; for the DehydraTECH-processed Rybelsus mouth-melt it was 1.27 or 32.3% of the Rybelsus tablet results; and for the DehydraTECH-processed Rybelsus it was 4.20 or 106.9% of the Rybelsus tablet results. The Company is unaware whether the in-mouth dissolvable tablet product format has ever been used before to attempt to deliver a GLP-1 drug. As such, there was a real possibility that it would fail to do so. Instead, it delivered roughly one-quarter to one-third of the quantity of drug into blood as the Rybelsus tablet. If this absorption is additive to the existing gastrointestinal absorption, this could be a very interesting incrementally positive result. This was the first Study designed to investigate whether DehydraTECH-enhanced semaglutide can absorb at any level systemically through the sublingual/buccal tissues of the mouth and throat with some effective drug delivery into the bloodstream. As this published study notes, the level of expected weight loss associated with GLP-1 drugs is directly correlated with the quantity of GLP-1 drug circulating in the blood stream. It is for this reason that Lexaria is constantly pursuing any and all improvements in drug delivery that are possible.