Ethics Board Approval Granted for Lexaria's 12-Week Phase 1b DehydraTECH GLP-1 Study in Diabetes and Weight Loss

DehydraTECH clinical test article manufacturing has been completed

KELOWNA, BC / ACCESSWIRE / November 13, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX, LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has received lead clinical site human research ethics committee ("HREC") approval that was required before dosing can begin in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study").

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 (positive control)

Arm 5 - DehydraTECH-tirzepatide capsules (optional arm with offset start date)

It is possible that the First Patient, First Dose ("FPFD") Study milestone could be achieved in late December, and failing that, in January, 2025.

"We are delighted by the work of our project team in completing study documentation preparation and primary ethics board submission so quickly and efficiently," said John Docherty, President of Lexaria Bioscience Corp. "Their nearly round-the-clock work has resulted in a rapid ethics board approval so that the study can start dosing as soon as possible. Together with our expedited manufacturing processes recently completed, we have potentially saved months of time."

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 ("FDA").

About The Study

The Study is planned to commence with 20 overweight, obese, pre- or type 2 diabetic patients for each of Study arms 1-4, with the DehydraTECH-tirzepatide Study arm 5 to be added at a later date if supported by positive results from Lexaria's separate ongoing study GLP-1-H24-3. All drugs will be administered daily by oral tablet or capsule - there are no drug injections involved in this Study.

Arms 2 and 3 of the Study will use DehydraTECH-processed pure semaglutide and will be compared to Study Arm 4 which will use Rybelsus® tablets (semaglutide) that contains Novo Nordisk's proprietary salcoprozate sodium ("SNAC") technology. It is a world-first that pure semaglutide processed with DehydraTECH technology without SNAC will be compared directly to SNAC-enabled Rybelsus® in a multiple week human study.

Arm 1 of the Study will utilize a proprietary, patented DehydraTECH-CBD formulation. Our 2022 diabetes animal study DIAB-A22-1, utilizing DehydraTECH-CBD evidenced weight loss of 7% and reduced blood glucose levels of 19.9%+/-7% (p