Lexaria Bioscience receives HREC approval for Phase 1b DehydraTECH GLP-1 study

Lexaria Bioscience (LEXX) has received lead clinical site human research ethics committee approval that was required before dosing can begin in the Company’s Phase 1b, 12-week chronic study GLP-1-H24-4. The Company is also announcing that clinical test article manufacturing for all planned Study arms has already been completed. This includes production for the four planned DehydraTECH formulation Study arms and clinical repackaging of the commercially available Rybelsus comparator tablets for the Study control arm as follows: Arm 1 – DehydraTECH-CBD capsules; Arm 2 – DehydraTECH-semaglutide capsules; Arm 3 – DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules; Arm 4 – Rybelsus tablets; Arm 5 – DehydraTECH-tirzepatide capsules. It is possible that the First Patient, First Dose Study milestone could be achieved in late December, and failing that, in January, 2025. The Study is planned to be conducted using seven clinical investigational sites in Australia as a registrational Phase 1b study within Australian clinical regulatory authority regulations. HREC approval has been received for the primary clinical site, while clinical trial notification acknowledgement by the Australian Therapeutic Goods Administration and HREC approvals for the remaining clinical sites remain to be completed; but expected shortly now that primary site HREC approval is in hand. Quality control release testing of the clinical test articles also remains to be completed. The Study, upon completion, is expected to be equally regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration.