COSCIENS Biopharma Inc. announced today the successful completion of Phase 1 clinical trials for its flagship avenanthramide product, paving the way for Phase 2a efficacy studies in patients with inflammatory conditions. The company reported no significant adverse events in the initial safety study, positioning the oat-derived compound as a promising candidate for anti-inflammatory applications.
The Phase 1 portion of the AvenActive study evaluated the safety, tolerability, and pharmacokinetics of the company's avenanthramide formulation in 72 healthy subjects. The trial included both single ascending dose (SAD) and multiple ascending dose (MAD) arms, with participants receiving doses ranging from 30 mg to 960 mg daily.
Based on the favorable safety profile observed, the Data Safety and Monitoring Board has recommended proceeding to Phase 2a efficacy trials. The next phase will enroll 20 patients with mild to moderate inflammation, who will receive either 480 mg or 960 mg daily doses. The first patient is expected to begin treatment on March 14, 2025, at the Montreal Heart Institute.
The Science Behind Avenanthramides
Avenanthramides are di-phenolic compounds found exclusively in oats that have attracted scientific interest for their potent antioxidant and anti-inflammatory properties. These natural compounds have demonstrated bioactivity in both laboratory and animal studies.
According to published research, avenanthramides may influence signal transduction pathways and modulate pro-inflammatory gene expression, including key cytokines and enzymes. The AvenActive study will assess their effects on inflammatory biomarkers in blood, focusing on cytokines, chemokines, and high-sensitivity C-reactive protein.
Dr. Jean-Claude Tardif, principal investigator and Director of the Research Center at the Montreal Heart Institute, expressed optimism about the compound's potential: "The Phase 1 portion of the AvenActive study has been very encouraging, demonstrating an excellent safety profile with no significant adverse events to date. With these positive results, we are now enthusiastically advancing into Phase 2a to assess whether the Company's avenanthramide product exhibits signs of activity in subjects with low-grade inflammation."
Dr. Tardif further noted that findings from the Phase 2a study "could provide critical insights into the potential role of avenanthramides in reducing vascular inflammation and improving cardiovascular health."
From Natural Compound to Pharmaceutical Product
COSCIENS Biopharma, formed through the merger of Aeterna Zentaris and Ceapro Inc., specializes in developing natural compounds for cosmeceutical, nutraceutical, and pharmaceutical applications. The company leverages proprietary extraction technology to produce active ingredients from renewable plant resources.
Avenanthramides are already used in cosmeceutical products, including formulations by well-known skincare brands like Aveeno and Burt's Bees. However, COSCIENS aims to expand their application into the pharmaceutical realm, specifically targeting inflammatory conditions.
"COSCIENS Biopharma is advancing this groundbreaking research with a natural product with the highest scientific rigor," said Gilles Gagnon, M.Sc., MBA, President and CEO of COSCIENS Biopharma. "The successful completion of Phase 1 clinical study represents a critical milestone for this biopharmaceutical development program."
Market Potential and Strategic Outlook
With the advancement to Phase 2a trials, COSCIENS believes it is strategically positioned to pursue out-licensing opportunities and potential commercialization partnerships with major pharmaceutical companies.
"Given its significant therapeutic and market potential, we believe our avenanthramide product could become a transformative product for COSCIENS, which aspires to become a global leader in natural-based products for health and wellness," Gagnon added.
The company's approach aligns with growing market interest in naturally derived compounds with pharmaceutical applications. By bridging the gap between nutraceuticals and pharmaceuticals, COSCIENS is targeting an expanding segment of the healthcare market that values natural origins alongside scientific validation.
Trial Design and Next Steps
The AvenActive study was designed as a double-blind, placebo-controlled, randomized, adaptive, first-in-human trial. The Phase 2a portion will specifically assess the compound's efficacy in patients with evidence of mild to moderate inflammation.
Dr. Tardif's team at the Montreal Heart Institute has already recruited the first patients for the Phase 2a trial. The Montreal Heart Institute, Canada's largest cardiology research center, brings significant expertise to the study, particularly in cardiovascular inflammation research.
If successful, the Phase 2a results could position avenanthramides as a novel approach to managing inflammatory conditions, potentially offering a natural alternative or complement to existing anti-inflammatory therapies.
The company expects to report initial findings from the Phase 2a portion of the AvenActive study later this year, which will provide crucial data on the compound's efficacy in addressing inflammatory biomarkers in patients.
