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Lexaria Bioscience Corp. (NASDAQ:LEXXW) is a global innovator in drug delivery platforms known for its patented drug delivery technology, DehydraTECH. DehydraTECH enhances the absorption of active pharmaceutical ingredients, such as cannabinoids and nicotine, by promoting more effective oral delivery. The technology has shown to significantly increase bio-absorption, reduce onset times, and mask unwanted tastes. Lexaria operates in four main segments: Intellectual Property Licensing, B2B Production, Research and Development, and Corporate. With a robust intellectual property portfolio and ongoing research, Lexaria aims to revolutionize drug delivery methods and improve outcomes.
Lexaria Bioscience has awarded a contract research organization (CRO) to oversee a 12-week chronic human study, GLP-1-H24-4, evaluating DehydraTECH-GLP-1 formulations for weight loss and blood sugar reduction.
The study, the company’s most comprehensive GLP-1 investigation, will involve clinical sites in Australia and comply with Australian regulatory standards. Upon completion, it aims to gain recognition as a Phase 1b study by the U.S. FDA. Study preparations with the CRO include clinical protocol design, regulatory submissions, and data management planning.
Lexaria Bioscience continues progressing its second GLP-1 human pilot study (GLP-1-H24-2), with the second dosing arm now complete for all nine participants. The study, a three-arm crossover investigation, compares three 7 mg semaglutide dose formulations: a positive control Rybelsus® tablet, DehydraTECH-semaglutide swallowed capsules, and an innovative in-mouth dissolvable DehydraTECH-semaglutide oral tablet. This is the first study to investigate if DehydraTECH-enhanced semaglutide can be absorbed systemically via sublingual/buccal tissues, potentially offering better absorption and fewer side effects than swallowed administration. Lexaria plans to complete the final study arm by early July 2024.
Lexaria Bioscience has awarded a contract for its third human pilot study to a contract research organization. This study will evaluate the dual action glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) using a DehydraTECH-processed tirzepatide in an oral capsule format versus the injected tirzepatide (Zepbound® by Eli Lilly). The study aims to determine the absorption, human tolerability, and blood sugar level effects of the oral DehydraTECH-processed tirzepatide. This marks the first study of its kind for Lexaria, potentially paving the way for an FDA-approved oral dosage format of tirzepatide. Manufacturing for the study's test articles is expected to complete within 30 days, pending Independent Review Board approval.
Lexaria Bioscience has announced the receipt of two new US patents in the medical fields of hypertension and epilepsy. The first patent, part of Lexaria's patent family #21, focuses on compositions and methods for treating hypertension using DehydraTECH-processed cannabidiol (CBD). The second patent, part of patent family #24, pertains to treating epilepsy, highlighting DehydraTECH-CBD's efficacy in mitigating epileptic seizures and its superior absorption compared to Epidiolex. Both patents are valid until 2042. Lexaria now holds a total of 43 patents globally, reinforcing its strategic business objectives.
Lexaria Bioscience Corp. (NASDAQ: LEXX) has commenced dosing in a 12-week animal study, WEIGHT-A24-1, to evaluate the effectiveness of DehydraTECH-processed GLP-1 drugs, including semaglutide and liraglutide, in diabetic preconditioned rats. The study aims to determine whether these processed drugs improve brain absorption, weight loss, and blood sugar control, especially when combined with cannabidiol (CBD). The study consists of 12 arms, with initial evaluations focusing on pure and reformulated compositions of semaglutide and liraglutide. Subsequent study arms will explore the best-performing drug combinations and include placebo and positive control groups.
Lexaria Bioscience Corp. has commenced its second GLP-1 human pilot study, comparing different formulations of semaglutide for improved drug delivery. The study aims to test the effectiveness of DehydraTECH technology in enhancing oral absorption rates of GLP-1 drugs. The company has successfully completed the first dosing visit for all nine participants and expects the study to conclude by mid-June.
Lexaria Bioscience Corp. announces a research program with the National Research Council of Canada to evaluate DehydraTECH-GLP-1 drugs. The program will assess the molecular characteristics of semaglutide processed with DehydraTECH and its performance in simulated gastric conditions. The partnership aims to accelerate the integration of DehydraTECH with GLP-1 drugs into the pharmaceutical industry. Testing methods include PAGE, SEC, MALDI MS, and DLS to study the oligomerization potential of DehydraTECH-processed semaglutide. Initial results show increased peak levels of semaglutide in blood with reduced adverse events and improved blood sugar control compared to unprocessed Rybelsus® tablets.
Lexaria Bioscience Corp. (NASDAQ: LEXX) announces a warrant exercise agreement with an investor, resulting in $4.7 million in gross proceeds. The company will issue new warrants at $4.75 per share, extending its operational runway into 2025. The funds will be used for working capital and general corporate purposes.
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