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COSCIENS Biopharma Inc. Announces Successful Phase 1 Results Supporting Initiation of Phase 2a Clinical Efficacy Trial with Avenanthramides as a Potential Anti-Inflammatory Product
No significant clinical adverse event observed in Phase 1clinical study Pharmacokinetic p...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"COSCIENS Biopharma Inc. Announces Successful Phase 1 Results Supporting Initiation of Phase 2a Clinical Efficacy Trial with Avenanthramides as a Potential Anti-Inflammatory Product\n\n\n\n\n\n No significant clinical adverse event observed in Phase 1clinical study\n \n\n\n\n Pharmacokinetic profile established and range of doses selected for Phase 2a Clinical Efficacy Study\n \n\n\n\n First patient expected to be treated in the Phase 2a Clinical Efficacy Study on March 14, 2025 at the Montreal Heart Institute\n \n\n\n\n\n\n TORONTO, ONTARIO, March 13, 2025 (GLOBE NEWSWIRE) --\n \n COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”), a life science company which develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products, today announced Initiation of its Phase 2a clinical efficacy study of its flagship avenanthramides product being developed for potential applications in managing conditions related to inflammation.\n \n\n Avenanthramides are di-phenolic compounds found exclusively in oats. They have garnered significant interest due to their suggested bioactivities, including potent antioxidant and anti-inflammatory effects both\n \n in vitro\n \n and\n \n in vivo\n \n .\n \n\n The Company initiated a clinical trial (Phase 1-2a) in November 2023 referred to as the AvenActive study. That trial is a double-blind, placebo-controlled, randomized, adaptive, first-in-human study designed to assess safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of the Company’s avenanthramide product. A total of 72 healthy subjects have completed the Phase 1 portion of the AvenActive study which included 48 healthy subjects in a single ascending dose (SAD) arms and 24 healthy subjects in multiple ascending dose (MAD) arms. Subjects received doses ranging from 30 mg to 960 mg per group per day. No significant adverse events were reported during the Phase 1 portion of the AvenActive study.\n \n\n Given the favorable safety profile of the Company’s avenanthramide product seen to date in the AvenActive study, the Data Safety and Monitoring Board recommended the Phase 2a portion of the AvenActive study be initiated with patients presenting evidence of mild to moderate inflammation. A total of 20 p...