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

Lexaria Bioscience announces that human pilot study #2, GLP-1-H24-2, continues to make progress and the second round of dosing for all nine study participants is now complete. Lexaria expects to complete the third arm of the Study in early July. The Study is a three-arm, crossover investigation that will compare 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 second 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 swallowed capsules. Lexaria’s final DehydraTECH Study arm will investigate an oral dissolvable tablet formulation, also compliant with the FDA IID, with DehydraTECH powered semaglutide from Ryblesus. This will be the first study designed to investigate whether DehydraTECH-enhanced semaglutide can absorb at any level systemically into 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 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. In the previously announced human pilot study with 7 volunteers, Lexaria demonstrated superior pharmacokinetic oral delivery performance of the DehydraTECH-enhanced GLP-1 drug semaglutide available commercially in the branded product Rybelsus.