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Lexaria Bioscience Corp. (NASDAQ:LEXX) is a pioneering company in the field of drug delivery technology. The company has developed and patented a unique drug delivery platform known as DehydraTECH™, which enhances the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. This technology is notable for significantly improving bio-absorption rates, reducing the onset time of drugs, and masking unpleasant tastes.
DehydraTECH™ has demonstrated remarkable efficacy in enhancing the bio-absorption of cannabinoids and nicotine, increasing their uptake by 5-10 times, and in some cases, by as much as 27 times compared to traditional formulations. This technology also shows potential in improving the delivery of certain drugs through the blood-brain barrier, making it particularly valuable for drugs targeting the central nervous system.
The company operates four key segments: Intellectual Property Licensing, B2B Production, Research and Development, and Corporate. Intellectual Property Licensing is the primary revenue generator for Lexaria, leveraging its robust portfolio of 43 granted patents and numerous pending patents worldwide.
Lexaria's recent endeavors include a series of human and animal studies focused on the application of DehydraTECH™ in enhancing the delivery and efficacy of GLP-1 drugs. These drugs, such as semaglutide and tirzepatide, are primarily used for treating diabetes and promoting weight loss. The company has partnered with the National Research Council of Canada (NRC) to investigate the molecular characteristics and performance of DehydraTECH-processed GLP-1 drugs.
The latest human pilot studies have shown promising results, including higher drug delivery and better blood glucose control with fewer side effects. The company is also exploring the use of DehydraTECH™ for other APIs like cannabidiol (CBD), with applications in treating hypertension and epilepsy.
Recent financial activities include a warrant exercise agreement, raising approximately $4.7 million, which bolsters Lexaria's operational runway into 2025. This financial stability allows the company to pursue its aggressive research and development plans.
Lexaria's innovative approach and continuous research efforts position it as a significant player in the drug delivery technology sector, with the potential to form strategic partnerships with leading pharmaceutical companies.
Lexaria Bioscience (NASDAQ:LEXX) has outlined its triple-pronged strategy in the GLP-1 drug sector, focusing on its DehydraTECH technology. The strategy includes: collaborating with pharmaceutical companies through material transfer agreements; developing patented DehydraTECH-CBD products for GLP-1 applications; and investigating an oral version of liraglutide.
The company's DehydraTECH technology addresses two major challenges in GLP-1 drugs: injection administration and gastrointestinal side effects. Clinical testing has shown DehydraTECH's delivery superiority to Rybelsus, the only existing oral GLP-1 drug. The technology has demonstrated reduced side effects in both tirzepatide and semaglutide.
This development comes as the FDA recently approved Ozempic (semaglutide) for chronic kidney disease treatment in type 2 diabetes patients. The GLP-1 sector is expected to generate over $100 billion in annual revenue, with some forecasts reaching $471 billion.
Lexaria Bioscience (NASDAQ:LEXX) has received lead clinical site human research ethics committee (HREC) approval for the 5th study arm of its Phase 1b, 12-week chronic study GLP-1-H24-4 in Australia. This follows the November 13, 2024 approval for the first 4 arms. The study includes five arms: DehydraTECH-CBD capsules, DehydraTECH-semaglutide capsules, DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules, Rybelsus® tablets, and DehydraTECH-tirzepatide capsules.
The study commenced with First Patient First Dose in December 2024. Additional HREC approval for other clinical sites is pending and expected soon. The study aims to evaluate the potential enhancement of GLP-1 drugs through Lexaria's DehydraTECH delivery technology, focusing on oral administration rather than injections.
Lexaria Bioscience (NASDAQ:LEXX) has announced its strategic pursuit of developing the world's first oral version of liraglutide using their DehydraTECH technology. The company has filed patent applications following successful animal studies that showed DehydraTECH-liraglutide outperformed Rybelsus control group by 11.53% in blood sugar control and 11.13% in body weight control by week 12.
The company has received ethics board approval to commence human pilot study GLP-1-H25-5, comparing oral DehydraTECH-processed Saxenda to conventional injected liraglutide. This initiative is part of Lexaria's broader strategy to enter the GLP-1 weight loss and diabetes control market, which has grown from $300 million in 2018 to approximately $30 billion in 2024.
Currently, liraglutide is only available in injectable form under Saxenda and Victoza brands by Novo Nordisk, generating $849 million in H1 2024 and $1.6 billion in recent annual revenue respectively.
Lexaria Bioscience (Nasdaq: LEXX) has been granted two new patents from the United States Patent and Trademark Office for its DehydraTECH enhanced processing technology in epilepsy treatment. These represent the company's 5th and 6th US patents in its patent family #24, 'Compositions and Methods for Treating Epilepsy,' bringing Lexaria's total granted patents to 48.
The patents, set to expire in 2043 unless extended, build upon previous research demonstrating that DehydraTECH-CBD could mitigate epileptic seizures in rodents and showed superior bloodstream absorption compared to Epidiolex, a commercial cannabinoid-based anti-seizure medication.
Lexaria Bioscience (Nasdaq:LEXX) has initiated a groundbreaking rodent biodistribution study to track DehydraTECH-processed semaglutide. The study aims to compare the biodistribution patterns of DehydraTECH-processed semaglutide against conventional Rybelsus®-like formulations.
The research utilizes fluorescently tagged semaglutide (FTS) in Sprague-Dawley rats, examining distribution patterns in key tissues including brain, pancreas, lung, kidney, liver, and heart. The study incorporates two test formulations: one mimicking Rybelsus® without DehydraTECH, and another using Lexaria's patented DehydraTECH process.
The study employs immunofluorescence methodology to detect GLP-1 receptor binding, providing detailed insights into tissue distribution and localization patterns. Results will be used to enhance communications with potential industry partners.
Lexaria Bioscience (NASDAQ:LEXX) has provided updates on its ongoing Phase 1b, 12-week chronic study GLP-1-H24-4 in Australia. The company has completed its submission to the human research ethics committee (HREC) to add Study Arm 5, which will evaluate the performance of its DehydraTECH-tirzepatide formulation. This addition follows positive findings from their previous Human Pilot Study #3.
The company has received HREC approval for all 4 original arms across all participating clinical sites, following earlier approval for the lead clinical site. Clinical test article manufacturing has been completed. The company's previous Human Pilot Study #3 demonstrated comparable results in blood glucose reduction and insulin levels, along with significantly reduced adverse events when Eli Lilly's Zepbound® was processed with Lexaria's DehydraTECH™ technology.
Lexaria Bioscience (NASDAQ:LEXX) released its annual CEO letter highlighting significant achievements in 2024, particularly in GLP-1 drug delivery technology. The company raised $13.4M net through equity raises and warrant exercises, while its stock price increased 68% during the year.
Key developments included successful completion of multiple studies demonstrating positive results with DehydraTECH technology for GLP-1 drugs: semaglutide, tirzepatide, and liraglutide. Notable outcomes included 18.8% higher semaglutide levels and 60% reduction in adverse events compared to Rybelsus®.
The company launched its first Phase 1b registrational study in Australia and received FDA clearance for a Phase 1b hypertension study. Lexaria secured 8 additional patents, expanding its portfolio to 46 patents worldwide, and entered into a Material Transfer Agreement with a pharmaceutical company for pre-clinical evaluation of DehydraTECH technology.
Lexaria Bioscience Corp. (LEXX) has received independent ethics board approval for its human pilot study GLP-1-H25-5, which will compare oral DehydraTECH-liraglutide to injectable Saxenda®. This follows successful animal studies where oral DehydraTECH-liraglutide showed a 5.88% weight reduction and 11.54% blood sugar reduction compared to baseline.
The study will involve 8-10 healthy volunteers to demonstrate safety and pharmacokinetic performance of orally dosed DehydraTECH-liraglutide. Positive results could lead to a Phase I registered trial. Liraglutide, currently sold only as injectable Saxenda® and Victoza®, generated US$849 million (Saxenda®) in H1 2024 and US$1.6 billion (Victoza®) in recent annual revenue.
Lexaria Bioscience (NASDAQ:LEXX) announced partial results from study GLP-1-H24-3, comparing oral DehydraTECH-tirzepatide to injectable Zepbound®. The oral version showed 47% fewer total adverse events and 54% fewer gastrointestinal-related events compared to the injectable version.
The oral formulation demonstrated comparable blood glucose reduction and insulin secretion levels to injected Zepbound®. Blood glucose levels decreased from 88.2±9.0 to 83.2±5.7 mg/dL for oral DehydraTECH-tirzepatide, compared to 87.8±11.3 to 81.7±4.0 mg/dL for injected Zepbound®. At peak times, the oral version induced insulin levels up to 100% higher than the injection.
Based on these promising results, Lexaria plans to add a fifth study arm to its ongoing 12-week human study in Australia (GLP-1-H24-4), testing oral DehydraTECH-tirzepatide at current and doubled doses.
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.