Lexaria Bioscience Corp. announces progress updates for its Human Pilot Study #3, including the addition of a new arm to evaluate its DehydraTECH-tirzepatide formulation, and the receipt of HREC approval for all study arms across participating clinical sites.
Lexaria Bioscience Corp. (NASDAQ:LEXX), a global innovator in drug delivery platforms, has announced encouraging progress updates on its ongoing Human Pilot Study #3. The Company is excited to reveal that it has received Human Research Ethics Committee (HREC) approval for all four original arms of the study at all participating clinical sites. This follows the initial HREC approval received for the lead clinical site and the completion of all clinical test article manufacturing.
John Docherty, President and Chief Scientific Officer of Lexaria Bioscience Corp., expressed gratitude towards the regulatory and clinical teams for their dedication in achieving these milestones. He particularly highlighted the prospect of adding Study Arm 5, which will evaluate the performance of the Company's DehydraTECH-tirzepatide formulation. This addition stems from the positive findings of a previous separate study conducted by Lexaria. The Company's Human Pilot Study #3 is currently underway, enrolling 20 overweight, obese, pre- or type 2 diabetic patients in each of the four original arms (Study Arms 1-4). Study Arm 5, focused on testing DehydraTECH-processed pure tirzepatide, is in the process of being added due to those aforementioned positive results. All drugs in the study will be administered daily via oral tablets or capsules, eliminating the need for injections, as Lexaria aims to shift the standard of care away from injections and embrace oral DehydraTECH delivery.The study's primary objectives are to assess the safety and efficacy of DehydraTECH-processed CBD, semaglutide, and/or tirzepatide over the study duration in the target population. It also seeks to determine if DehydraTECH-processed (pure) semaglutide outperforms Rybelsus®-semaglutide, which incorporates Novo Nordisk's proprietary salcoprozate sodium (SNAC) technology, in terms of blood sugar control and weight loss. Further, the study investigates whether DehydraTECH processing enhances real-world outcomes such as weight loss and blood sugar control over the 12-week period and if DehydraTECH processing of pure semaglutide leads to reduced side effects during daily dosing. Lexaria's DehydraTECH™ technology is a patented drug delivery formulation and processing platform that enhances the absorption of active pharmaceutical ingredients (APIs) through oral administration. Since 2016, Lexaria has conducted extensive research and development on DehydraTECH, exploring its application with various beneficial molecules in oral and topical formats. DehydraTECH has consistently demonstrated the ability to increase bio-absorption and potentially improve the delivery of certain drugs across the blood-brain barrier, a feature Lexaria considers particularly important for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a strong intellectual property portfolio with 46 granted patents and numerous patents pending worldwide
Drug Delivery Dehydratech Tirzepatide Semaglutide Clinical Trials Lexaria Bioscience Human Pilot Study Rybelsus
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