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About Lexaria Bioscience Corp.
Lexaria Bioscience Corp. (NASDAQ:LEXX, NASDAQ:LEXXW) is a global innovator in drug delivery technology, specializing in its patented DehydraTECH™ platform. This groundbreaking technology enhances the way active pharmaceutical ingredients (APIs) are absorbed into the bloodstream, offering faster onset times, improved bioavailability, and reduced side effects. DehydraTECH is applicable across a wide range of APIs, including cannabinoids, antiviral drugs, nicotine, and GLP-1 receptor agonists, making it a versatile solution in the pharmaceutical and biotechnology industries.
Core Technology: DehydraTECH™
DehydraTECH™ is a patented drug delivery formulation and processing platform that optimizes the oral delivery of APIs. By improving bio-absorption rates—up to 27 times higher for cannabinoids in some cases—and reducing onset times from hours to minutes, the technology addresses critical challenges in drug delivery. It has also demonstrated the ability to facilitate the transport of APIs across the blood-brain barrier, a significant advantage for treating neurological conditions.
Market Applications
Lexaria’s technology is particularly impactful in high-growth markets:
- GLP-1 Drugs: DehydraTECH has shown promise in enhancing the oral delivery of GLP-1 receptor agonists like semaglutide, liraglutide, and tirzepatide, which are used to treat diabetes, obesity, and cardiovascular diseases. By enabling oral formulations, Lexaria aims to replace the widely disliked injectable versions of these drugs.
- Neurological Disorders: The technology's ability to cross the blood-brain barrier positions it as a valuable tool in treating conditions like epilepsy and Alzheimer’s disease.
- Cannabinoids: DehydraTECH optimizes the delivery of cannabinoids for therapeutic applications, including pain management and seizure mitigation.
Business Model and Revenue Streams
Lexaria operates through four primary segments:
- Intellectual Property Licensing: The company licenses its technology to pharmaceutical and nutraceutical companies, generating recurring revenue.
- B2B Production: Lexaria produces DehydraTECH-enhanced formulations for business partners.
- Research and Development: The company conducts extensive R&D to expand its technology’s applications and validate its efficacy.
- Corporate Operations: This includes strategic planning and partnerships to drive growth.
Competitive Landscape
In the GLP-1 drug market, Lexaria competes with pharmaceutical giants like Novo Nordisk and Eli Lilly. However, its ability to deliver APIs effectively through oral formulations offers a distinct competitive edge. The company’s focus on reducing gastrointestinal side effects and improving patient compliance further strengthens its market position.
Intellectual Property
Lexaria boasts a robust intellectual property portfolio with 48 granted patents and numerous pending applications worldwide. These patents cover a wide range of applications, from epilepsy treatment to GLP-1 drug delivery, reinforcing the company’s authority in drug delivery innovation.
Research and Development
Lexaria operates a licensed in-house research laboratory, conducting preclinical and clinical studies to validate its technology. Recent studies have shown promising results in enhancing the performance of GLP-1 drugs, cannabinoids, and antiviral formulations. The company is also exploring new applications in cardiovascular and neurological health.
Geographical Reach
Lexaria generates revenue primarily from the United States and Canada, with plans to expand its global footprint through strategic partnerships and licensing agreements.
Conclusion
Lexaria Bioscience Corp. is at the forefront of drug delivery innovation, leveraging its patented DehydraTECH™ technology to address critical challenges in the pharmaceutical industry. By enabling more effective oral formulations, the company is poised to disrupt markets dominated by injectable drugs, offering significant benefits to patients and healthcare providers alike.
Lexaria Bioscience Corp. (NASDAQ:LEXX) has announced positive results from its second GLP-1 human pilot study (GLP-1-H24-2) on DehydraTECH-processed Rybelsus® oral capsules. Key findings include:
1. Superior tolerability: None of the 9 participants taking DehydraTECH-processed Rybelsus® capsules experienced adverse events, compared to 6 out of 9 taking standard Rybelsus® tablets.
2. Improved absorption: DehydraTECH-processed Rybelsus® capsules showed 106.9% blood concentration levels compared to standard Rybelsus® tablets.
3. Novel delivery method: A DehydraTECH-processed Rybelsus® mouth-melt format showed promising results, delivering about one-third of the drug concentration of standard tablets.
These findings suggest that Lexaria's DehydraTECH technology could potentially enhance the oral delivery and tolerability of GLP-1 drugs like semaglutide, which may lead to increased use of oral GLP-1 products in the future.
Lexaria Bioscience Corp. (NASDAQ:LEXX) has announced initial results from its second GLP-1 human pilot study, GLP-1-H24-2. The study compared DehydraTECH-processed Rybelsus to standard Rybelsus under fed conditions. Key findings include:
1. DehydraTECH-processed Rybelsus showed 18.8% higher average semaglutide levels over 24 hours.
2. Higher semaglutide levels were observed in 17 out of 19 blood draws.
3. The study used 7 mg semaglutide doses in both arms.
4. Results were not statistically significant due to small sample size.
These findings complement an earlier study showing a 43% peak blood level improvement under fasted conditions. Lexaria plans to continue its 2024 GLP-1 program with ongoing animal studies and a planned 12-week chronic human study.
Lexaria Bioscience Corp. (NASDAQ:LEXX) has released 8-week body weight results from its ongoing animal study WEIGHT-A24-1. The study evaluates the performance of DehydraTECH-processed liraglutide and semaglutide, as well as various DehydraTECH-CBD formulations. Key findings include:
1. DehydraTECH-liraglutide (Group H) showed the most significant weight loss at -4.74%.
2. Two DehydraTECH-CBD formulations (Groups B and C) outperformed DehydraTECH-semaglutide and Rybelsus compositions.
3. All DehydraTECH drug therapies resulted in weight decreases or slower weight gain compared to the initial acclimation phase.
The study is ongoing, with additional results expected. Lexaria cautions against direct comparisons to human weight loss studies due to the unlimited food and water provided to the animals.
Lexaria Bioscience Corp. (NASDAQ:LEXX) has announced positive interim blood sugar results from its ongoing GLP-1 diabetes animal study WEIGHT-A24-1. Key findings include:
1. DehydraTECH-liraglutide and two DehydraTECH-CBD formulations showed the best performance at day 56, with blood sugar level reductions of 2.50%, 1.90%, and 1.53% respectively.
2. All 8 active groups experienced smaller increases or actual decreases in blood sugar levels compared to the obese control group from a previous study.
3. DehydraTECH-liraglutide outperformed DehydraTECH-semaglutide, which is notable as semaglutide typically outperforms liraglutide in human studies without DehydraTECH processing.
The study is ongoing, with additional results expected soon.
Lexaria Bioscience Corp. (NASDAQ:LEXX) has announced positive results from its molecular characterization study of DehydraTECH-processed semaglutide, a GLP-1 drug. The study, conducted with the National Research Council of Canada, compared DehydraTECH-processed pure semaglutide to the commercial formulation Rybelsus®. Key findings include:
1. Semaglutide was efficiently released in simulated gastric fluid.
2. The drug likely remained in monomeric form, similar to Rybelsus®.
3. DehydraTECH achieved monomeric form without using SNAC, a proprietary ingredient in Rybelsus®.
This is significant as the monomeric form allows for better permeation of the gastric epithelium. The results suggest DehydraTECH's potential in oral GLP-1 drug delivery, a market where Novo Nordisk paid ~$1.8 billion for SNAC technology in 2020.
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.
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