RE:Safety/tolerability profileWe've never seen any preclinical data for the avenanthramide pill formulation or much of an explaination of what exactly it is. It is a mystery. Do they have preclinical data supporting a compelling potential efficacy profile that is further supported by other avenanthramide clinical trials; including in humans? A compelling data-driven argument for the pill in combination with human safety/tolerability data could be material. Gilles said it was because of avenanthramide that he joined the company. He once said he doesn't like to talk about the upside given the size of the market but the non-steroidal anti-inflammatory market is worth $50 billion and a new enterant can achieve significant market share in its first year. AEZS's program has been a carefully guarded secret for competitive reasons.
The doctor in charge of AEZS's clinical trial is a noted authority on inflammation and heart disease and participated in colchicine's clinical trials. Colchicine was recently the first treatment approved for inflammation and heart disease. The doctor also ran the largest out-patient clinical trial for COVID and COVID and heart inflammation is a significant issue. Gilles has talked about his interest in COVID and heart inflammation for this pill preivously.
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With significant market potential and patient benefit, we believe avenanthramides is poised to be the biggest product for Ceapro,” concluded Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro.
Dr. Jean-Claude Tardif, the principal investigator of the study and Director of the Research Center at the Montreal Heart Institute stated, "We are excited to explore the potential therapeutic benefits of avenanthramides and believe results from this study could mark a significant step forward in understanding the potential of avenanthramides in cardiovascular disease. Not only will the study assess safety of avenanthramides in healthy subjects, but it could also provide early signs of activity in subjects with low grade inflammation as part of the Phase 2a component. The results of such studies will provide valuable insights into the potential role of avenanthramides in reducing vascular inflammation and may have implications for cardiovascular health.”