Lexaria Bioscience Corp. (Nasdaq: LEXX) has commenced dosing in its Phase 1b, 12-week chronic study GLP-1-H24-4, designed to evaluate whether the company's proprietary DehydraTECH technology can improve the safety and effectiveness of existing GLP-1 (glucagon-like peptide-1) drugs. The trial, conducted across seven clinical sites in Australia, includes multiple arms testing various combinations of DehydraTECH-processed drugs and is anticipated to be recognized as a Phase 1b registrational study by the FDA.
Trial Design and Objectives
The GLP-1-H24-4 study includes five arms:
- 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 (potential additional arm)
The study aims to enroll 20 overweight, obese, pre- or type 2 diabetic patients for each of the first four arms. The primary objective is to assess the safety and efficacy of DehydraTECH-processed CBD and semaglutide over the 12-week study duration. Key outcomes include evaluating improvements in blood sugar control and weight loss, as well as potential reductions in side effects compared to Rybelsus alone.
DehydraTECH Technology and Rationale
DehydraTECH is Lexaria's patented drug delivery formulation and processing platform designed to improve how active pharmaceutical ingredients enter the bloodstream through oral delivery. According to Lexaria, this technology has repeatedly demonstrated the ability to increase bio-absorption and, in some cases, enhance drug delivery across the blood-brain barrier.
The rationale behind using DehydraTECH with GLP-1 drugs is to potentially enhance their efficacy and reduce side effects. In a previous human study, Lexaria reported that DehydraTECH processing of Rybelsus-branded semaglutide improved blood sugar control and increased semaglutide levels in the blood after a single dose compared to Rybelsus itself.
Comparison with Rybelsus and SNAC Technology
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. Lexaria aims to demonstrate that pure semaglutide processed with DehydraTECH technology without SNAC can achieve comparable or superior results to SNAC-enabled Rybelsus.
Potential Market Impact
John Docherty, President and Chief Scientific Officer of Lexaria Bioscience Corp., stated, "The world's first 12-week human study evaluating DehydraTECH-processed GLP-1 drugs, in addition to DehydraTECH-CBD, in pre-diabetics or diabetic patients is underway. Potential benefits of reduced side-effects and improved efficacy could be evidenced."
Given the projected GLP-1 market size of over $150 billion by 2030, successful study outcomes could significantly impact Lexaria's market position. The company's focus on improving established GLP-1 drugs offers a potentially lower-risk development pathway with the opportunity to capture substantial value through enhanced drug delivery.
