COSCIENS Biopharma Inc（CSCI）のニュースとイベントCSCICOSCIENS Biopharma Inc

Cosciens Biopharma announces initiation of Phase 2a study for avenanthramides

COSCIENS Biopharma 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. 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 in vitro and in vivo. The Company initiated a clinical trial 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 arms and 24 healthy subjects in multiple ascending dose 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. 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 patients will be enrolled in the Phase 2a portion of the AvenActive Study which is designed to assess potential efficacy in two arms with patients receiving selected doses of 480 mg and 960 mg per day. Dr.Tardif's team at the Montreal Heart Institute has already recruited the first patients and initial dosing is expected to occur on March 14, 2025.

Cosciens Biopharma provides update, reiterates pipeline prioritization

COSCIENS Biopharma provided a corporate update and reiterated its pipeline prioritization. The company said, "Pharmaceuticals: Avenanthramides Tablets in Development as an Anti-Inflammatory: The Phase 1-2a clinical trial being conducted at the Montreal Heart Institute has fully completed the Phase 1 part of the study with 72 subjects tested. No significant side effects have been observed from ascending doses ranging from 30 mg to 960 mg. The Company expects the Phase 2a efficacy study will be initiated in Q1 2025, with expected completion in Q3 2025. Cosmeceuticals: Enriched Oat Flour with High Concentration of Avenanthramides: We have successfully produced and sold small batches for inclusion in cream formulations. JuventeDC Product Line: New website, juventedc.com, was launched on December 19, 2024. Nutraceuticals: Yeast Beta Glucan Powder - Immune Booster: Our YBG product has been successfully manufactured as part of our PGX scale up project in Edmonton, Alberta. Our YBG product is being finalized in capsule form with the goal to commercialize it as an immune booster in Q2 2025. Oat Beta Glucan Chewable Bar - Cholesterol Reduction: We have successfully developed a unique, standardized formulation for a healthy confection which includes a high concentration of OBG with daily dosage according to approved claims in 10 developed countries. The substantive claims include reduction of LDL cholesterol, supporting cardiovascular health reduction of Type 2 diabetes risks, source of fiber for the maintenance of general good health and support of a healthy digestive system. COSCIENS' team anticipates the official commercial launch of its chewable bar OBG natural health product in Q1 2025, marking an important chapter in the Company's journey toward promoting wellness while expanding its business model. Macimorelin: On August 27, 2024, the Company announced that the Phase 3 safety and efficacy study AEZS-130-P02 evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency had failed to meet its primary endpoints according to the definitions in the study protocol. Based on the results of the study, we are prioritizing our pipeline moving forward and repositioning the Company as a pure play Life Science's business offering natural-based products. Therefore, while maintaining the current commercial indication for the use of macimorelin for the diagnosis of Adult Growth Hormone Deficiency, the Company has decided to not make any future investments in macimorelin for the diagnosis of CGHD. Consequently, in order to further ensure the streamlining of operations and reduce costs, the roles of some additional members of management have been terminated, including Dr. Nicola Ammer, Chief Medical Officer, which will be ending on March 31, 2025." The Company plans to release a new corporate presentation outlining key development areas and upcoming milestones in January 2025.