Lexaria Bioscience completes dosing in second GLP-1 human pilot study

Lexaria Bioscience announces that human pilot study #2, GLP-1-H24-2, has now completed all dosing. The Study is a three-arm, crossover investigation comparing three 7 mg semaglutide dose formulations: a positive control Rybelsus swallowed tablet; DehydraTECH-semaglutide swallowed capsules; and for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet. The final DehydraTECH Study arm used a Rybelsus composition processed with DehydraTECH that is compliant with the U.S. Food and Drug Administration’s Inactive Ingredient Database, delivered within an in-mouth dissolvable tablet. This will be 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 fewer side effects than from swallowed administration, and with some effective drug delivery into the bloodstream. This is being explored because of the acidic environment of the stomach that seriously degrades GLP-1 drugs that are swallowed, resulting in exceptionally low blood absorption rates of less than 1% when an absorption technology is not used. All blood samples collected during the study are now being transported to the bioanalytical lab for analysis. We anticipate completing the analysis and announcing the Study results in late August or early September. Next steps include our evaluation and optimization of different semaglutide formulations in our already-underway animal study, as well as evaluation of semaglutide in our upcoming 12-week chronic human study.