Core Insights - Lexaria Bioscience Corp. has achieved a significant milestone in its Phase 1b GLP-1 study in Australia, completing the last patent last visit (LPLV) [1][2] - The study involved 126 participants and focused on evaluating various DehydraTECH formulations against a control arm using Rybelsus® [4][6] - Interim results have shown positive outcomes, particularly in safety and tolerability compared to the control arm, with a notable reduction in gastrointestinal adverse events [3] Study Details - The study included 24-25 overweight, obese, pre- or type 2 diabetic patients in each of the five study arms, with a total of 126 participants [4] - All doses were administered orally, with no injections involved, as Lexaria aims to shift the standard of care towards oral delivery [4] - The study arms included proprietary formulations of DehydraTECH-CBD and DehydraTECH-processed semaglutide, with the fifth arm evaluating DehydraTECH-tirzepatide [5][6][7] Future Objectives - Lexaria plans to release the final results of the study in the fourth quarter of 2025 [9] - The company is currently engaged in data analysis and sample processing, with a comprehensive database being developed [2] Technology Overview - DehydraTECH™ is Lexaria's patented drug delivery technology that enhances the bio-absorption of drugs through oral delivery, aiming to reduce side effects and improve efficacy [10] - The company holds a robust intellectual property portfolio with 50 patents granted and additional patents pending worldwide [10]

Core Insights - Lexaria Bioscience Corp. has reported positive interim results from its phase 1b study GLP-1-H24-4, focusing on its DehydraTECH drug delivery platform compared to Rybelsus® [1][2] Group 1: Study Results - After 8 weeks of treatment, DehydraTECH-GLP-1 arms showed a significant reduction in adverse events (AEs) compared to Rybelsus®, with 79.2% of DHT-semaglutide patients experiencing at least one AE versus 100% for Rybelsus® [2][4] - DehydraTECH-semaglutide demonstrated a 36.5% reduction in overall AEs and a 43.5% reduction in gastrointestinal (GI) AEs compared to Rybelsus® [3][4] - The total number of AEs for DHT-semaglutide was 61, while Rybelsus® had 96 AEs, indicating a 63.5% reduction in AEs for DHT-semaglutide relative to the control [2][4] Group 2: Efficacy Metrics - The study is assessing changes in glycated hemoglobin (HbA1c) and body weight as primary efficacy endpoints [7] - After 8 weeks, DHT-semaglutide resulted in an average weight loss of -1.14 kg (-1.23%), while DHT-tirzepatide showed a weight loss of -4.14 kg (-4.23%) [9][10] - HbA1c levels decreased by -0.14% for DHT-semaglutide, with no statistically significant difference compared to Rybelsus® at this interim stage (p=0.069) [11] Group 3: Comparative Analysis - In comparison to Novo Nordisk's® STEP studies, where 88.1% of patients experienced AEs, only 79.2% of patients in the DHT-semaglutide arm experienced AEs, suggesting a potential for improved patient adherence to treatment protocols [5] - The DHT-tirzepatide arm showed a lower proportion of GI-related AEs (22%) compared to injected tirzepatide studies, which reported 40% to 50% GI-related AEs [6] Group 4: Future Outlook - Additional data from the study will be processed and may be released in the coming weeks, with final results expected near the end of 2025 [12][13] - The study is approaching the "last patient last visit" milestone and remains on schedule [13]

Industry Overview - The GLP-1 weight loss and diabetes control sector is currently the fastest growing pharmaceutical sector globally, with revenue expectations exceeding $100 billion annually [2] - Updated projections indicate that the GLP-1 industry could generate over $156 billion in revenue by 2030, with a significant growth of 31% expected in 2025, reaching $70.1 billion [3] Challenges in the GLP-1 Sector - The GLP-1 industry faces significant challenges due to unwanted adverse effects, particularly gastrointestinal issues such as nausea, vomiting, diarrhea, and constipation [4] - Discontinuation rates among GLP-1 users with type 2 diabetes are high, with studies showing that 47% to 64% of users stop their medication within 1 to 2 years, primarily due to gastrointestinal adverse effects [5][6] Company Innovations - Lexaria Bioscience Corp. has developed DehydraTECH technology, which aims to reduce side effects associated with GLP-1 drugs, potentially improving patient retention and industry growth [8][9] - DehydraTECH has shown promise in clinical testing for reducing gastrointestinal adverse effects in the top GLP-1 drugs, including semaglutide, tirzepatide, and liraglutide [10] Strategic Initiatives - Lexaria is pursuing a multi-faceted strategy to attract pharmaceutical companies to adopt its DehydraTECH technology, evidenced by a material transfer agreement with a pharmaceutical company announced in September 2024 [11]

Core Insights - Lexaria Bioscience Corp. has successfully completed a human study comparing oral DehydraTECH-liraglutide to injected Saxenda®-branded liraglutide, with partial results now available [1][8] - The study demonstrated a 22.7% reduction in adverse events (AEs) for oral DehydraTECH-liraglutide compared to Saxenda®, with significant reductions in nausea (67%) and gastrointestinal AEs (31%) [3][4] - Lexaria is seeking a pharmaceutical partner to develop an FDA-registered oral alternative to current injectable GLP-1 drugs, addressing an unmet market need [2][10] Study Details - The study involved 10 overweight volunteers, comparing daily doses of Saxenda® (0.6 mg) and DehydraTECH-liraglutide (45 mg) over a 7-day period [13] - The primary endpoint was the evaluation of safety and tolerability, with secondary objectives including pharmacokinetics and effects on body weight, blood glucose, and insulin levels [16] - Weight loss was observed in 9 out of 10 participants in both study arms, although it was not the primary goal of the study [5] Technology and Market Context - DehydraTECH is a patented drug delivery technology that enhances bio-absorption and reduces side effects, with 48 patents granted and more pending [17] - The study's results suggest that DehydraTECH-liraglutide could provide a viable oral alternative to Saxenda® and other injectable liraglutide products, which generated significant revenue for Novo Nordisk [12] - Lexaria's approach may allow for an expedited FDA regulatory pathway under the 505(b)(2) application, contingent on demonstrating comparable performance to existing injectable versions [6][10]