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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 Corp. (Nasdaq: LEXX) reports positive interim results from its diabetes animal study WEIGHT-A24-1. After 28 days of dosing, DehydraTECH-processed drug therapies showed decreased body weight gain or weight reduction. Key findings include:
1. DehydraTECH-CBD formulation 3 and DehydraTECH-liraglutide produced the largest weight loss: -1.50% and -1.58% respectively.
2. DehydraTECH appears effective with both semaglutide and liraglutide.
3. DehydraTECH-processed pure semaglutide performed similarly to reformulated Rybelsus® with SNAC technology.
4. Dosing for the final four study arms has begun, including combinations of DehydraTECH-processed drugs.
The study aims to explore potential enhancements in brain absorption and glucose control. Full results, including blood glucose and pharmacokinetic data, are pending.
Lexaria Bioscience Corp. (NASDAQ:LEXX) has announced plans for strategic growth. The company is expanding its management team, starting with the appointment of Nelson Cabatuan as consulting Chief Strategic Financial Advisor. Cabatuan is resigning from his role as CFO to focus on strategic opportunities. A new CFO will be announced soon.
Lexaria is also exploring additional R&D projects related to GLP-1 molecules beyond those previously disclosed. The company is considering concrete steps to launch its FDA-cleared Phase 1b hypertension study, subject to funding. CEO Chris Bunka expressed increased confidence in the company's medium and long-term strategies due to ongoing success and anticipated future achievements.
Lexaria Bioscience has completed dosing for its second human pilot study, GLP-1-H24-2, involving semaglutide. The study compared three 7 mg formulations: Rybelsus® swallowed tablets, DehydraTECH-semaglutide swallowed capsules, and an in-mouth dissolvable DehydraTECH-semaglutide tablet. This investigation aims to determine if DehydraTECH can enhance semaglutide absorption through oral tissues, potentially reducing side effects associated with stomach acid degradation. All blood samples are now being analyzed, with results expected by late August or early September. Lexaria is also optimizing semaglutide formulations in ongoing animal and upcoming 12-week human studies.
Lexaria Bioscience Corp. (NASDAQ:LEXX) has announced the receipt of three new patents, expanding its global patent portfolio to 46.
In the European Union, Lexaria received a patent in its family #6 for transdermal and dermal delivery of lipophilic active agents, valid in ten countries including the UK and Germany, expiring in 2039. In Canada, a new patent in family #18 for enhanced delivery of antiviral agents was granted, expiring in 2041. This patent builds on research showing improved drug delivery rates of 42% to 204% using DehydraTECH. Additionally, Lexaria received a fourth US patent in family #24 for treating epilepsy, expiring in 2044, based on research demonstrating DehydraTECH-CBD’s effectiveness in reducing seizures compared to Epidiolex®.
These patents strengthen Lexaria's intellectual property and support their future business goals.
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.
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