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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 (Nasdaq: LEXX) has initiated dosing in its Phase 1b, 12-week chronic study GLP-1-H24-4. The study aims to evaluate whether Lexaria's DehydraTECH technology enhances the safety and effectiveness of existing GLP-1 drugs. The trial includes multiple arms testing different combinations: DehydraTECH-CBD capsules, DehydraTECH-semaglutide capsules, a combination of both, Rybelsus® tablets as positive control, and potentially DehydraTECH-tirzepatide capsules. The study will be conducted across seven clinical sites in Australia and is expected to be recognized as a Phase 1b registrational study by the FDA.
Lexaria Bioscience Corp. (Nasdaq:LEXX) has announced the formation of a new Scientific Advisory Board (SAB) to guide its drug delivery platform technology development. The SAB will be chaired by John Docherty, Lexaria's President and Chief Scientific Officer, and includes three distinguished members: Dr. Michael Gibson, CEO of Baim and PERFUSE research institutes at Harvard Medical School; Dr. Karen Aust, Senior Director of Regulatory Affairs at G&L Healthcare Advisors; and Prof. Philip Ainslie, Research Chair at the University of British Columbia. The board will provide expertise in pharmaceutical development, clinical testing, and Chemistry Manufacturing and Controls (CMC) characterization, supporting Lexaria's commercialization efforts for its DehydraTECH technology.
Lexaria Bioscience (NASDAQ:LEXX) has appointed Dr. Michael Gibson as its new Chief Medical Advisor. Dr. Gibson, a highly cited interventional cardiologist and Harvard Medical School researcher, will work directly with President John Docherty to expand applications of Lexaria's DehydraTECH drug delivery platform in GLP-1 and hypertension.
As CEO of the Baim and PERFUSE research institutes at Harvard Medical School, Dr. Gibson has led over 1,250 studies and 70 FDA submissions. His institutes have published 5,500 manuscripts and operate across 7,000 sites in 57 countries. His research has been cited over 170,000 times, and he was named one of the Fifty Most Influential Voices in Healthcare by Medika Life in 2021.
Lexaria Bioscience (Nasdaq: LEXX) has engaged a CRO to conduct a human pilot study comparing oral DehydraTECH-liraglutide against injectable Saxenda®. This follows positive results from a 12-week rodent study where DehydraTECH-processed liraglutide showed a 5.88% weight reduction and 11.54% blood sugar reduction from baseline, outperforming Rybelsus® control.
The upcoming study, GLP-1-H25-5, will involve 8-10 healthy volunteers to evaluate safety and pharmacokinetic performance. If successful, it could lead to a Phase I registered trial. The market opportunity is significant, with Saxenda® generating $849 million in H1 2024 and Victoza® achieving $1.6 billion in recent annual revenue.
Lexaria Bioscience provides a strategic update on the expanding therapeutic benefits of GLP-1 drugs, highlighting their growing applications beyond diabetes and weight loss. The market, dominated by semaglutide and tirzepatide, has seen remarkable growth from $300 million in 2018 to projected $30 billion in 2024. New therapeutic applications being investigated include heart disease, Alzheimer's, liver disease, sleep apnea, knee pain, and chronic kidney disease. Clinical trials have shown promising results, including a 14% reduction in cardiovascular events and significant improvements in liver conditions, cognitive function, and kidney disease progression.
Lexaria Bioscience (Nasdaq: LEXX) announces completion of dosing in human pilot study #3, testing DehydraTECH-processed tirzepatide in oral format. The study involved nine healthy volunteers in a seven-day dosing phase, comparing oral DehydraTECH-processed tirzepatide capsules with injectable tirzepatide. No serious adverse events were observed during both dosing visits. The study evaluates tolerability, blood absorption levels, and blood sugar control. Tirzepatide, marketed as Zepbound® and Mounjaro®, is expected to generate $15 billion in revenue in 2024. Data analysis is expected in December with results available in January 2025.
Lexaria Bioscience Corp. (NASDAQ:LEXX) announces final 12-week results from its diabetes animal study WEIGHT-A24-1. All groups using DehydraTECH technology outperformed Rybelsus® in body weight control. DehydraTECH-liraglutide and DehydraTECH-CBD were top performers, surpassing Rybelsus® control group in body weight-loss by 11.53% and 10.65% respectively, and in blood sugar control by 11.13% and 3.35% respectively. The study maintained diabetic conditions by providing unlimited food and water to animals. DehydraTECH-semaglutide compositions, both with and without SNAC technology, showed superior weight control compared to placebo and standard of care groups.
Lexaria Bioscience Corp. (NASDAQ:LEXX) has contracted a research organization to conduct the first-ever fluorescently tagged DehydraTECH-semaglutide (FTS) rodent biodistribution study. The study will compare two formulations: one mimicking Rybelsus® and another using Lexaria's DehydraTECH processing. The research aims to track how semaglutide distributes in the body using fluorescent imaging in Sprague-Dawley rats, examining tissues including brain, pancreas, lung, kidney, liver, and heart. The study will also evaluate GLP-1 receptor binding patterns using immunofluorescence methodology. Results are expected in May 2025.
Lexaria Bioscience (Nasdaq:LEXX) has received lead clinical site human research ethics committee approval for its Phase 1b, 12-week chronic study GLP-1-H24-4 in diabetes and weight loss. The study will include five arms testing different DehydraTECH formulations: CBD capsules, semaglutide capsules, semaglutide combined with CBD capsules, Rybelsus tablets as control, and tirzepatide capsules as an optional arm. Clinical test article manufacturing for all study arms has been completed. First Patient, First Dose could begin in late December or January 2025. The study will be conducted across seven clinical sites in Australia and is expected to be recognized as a registrational Phase 1b study by the FDA.
Lexaria Bioscience Corp (NASDAQ:LEXX) provides an update on the GLP-1 industry and its strategic positioning. The company is developing its DehydraTECH™ drug delivery platform for application in the GLP-1 space, aiming to position it as essential technology for pharmaceutical companies. The GLP-1 sector has seen significant M&A activity, with major pharmaceutical companies like Novo Nordisk and Eli Lilly making substantial investments. Recent deals include Novo's $285 million license agreement with Ascendis Pharma, a $600 million collaboration with NanoVation Therapeutics, and the $1.08 billion acquisition of Inversago Pharma. The sector is projected to generate between $100 billion to $471 billion in annual revenue.
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