Ceapro Inc., a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, announced it has received approval from Health Canada to initiate its Phase 1/2a study evaluating the safety, tolerability, bioavailabilty and efficacy of its pharmaceutical grade tablet of avenanthramide as a potential anti-inflammatory product.
The study titled “A Double-Blind, Placebo-Controlled, Randomized, Adaptive, First-in-Human Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral doses of Avenanthramide” as part of the long-term agreement between Ceapro and the prestigious Montreal Heart Institute.
“Given the favorable effects of avenanthramide and the increased knowledge on inflammation-based diseases, especially in the cardiovascular area, we believe this study will offer insights in this first-in-class product for a potential new approach for patients,” commented Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Center and Principal Investigator for this clinical trial.
This Phase 1/2a trial is a double-blind, placebo-controlled, randomized, adaptive, single- and multiple-dose escalating study in sequential cohorts of healthy subjects, and subjects with low-grade inflammation. Up to 96 subjects may be included in the study and dosages will escalate from 30 mg to 960 mg according to response. Recruitment is anticipated to commence early in 2023. In addition to safety, tolerability and pharmacokinetics data, the study will explore the effect of avenanthramide on plasma markers of a variety of cardiometabolic indicators as well as inflammatory biomarkers, thus providing initial signals on the activity of Ceapro’s formulation. Potential indications for the systemic use of Ceapro’s avenanthramide are anticipated in the inflammatory component of vascular disease, atherosclerosis, diabetes, exercise induced inflammation, lung inflammation and, conceivably, in cardiovascular pathology associated with COVID-19.
“The commencement of this study represents a noteworthy milestone in the development of our avenanthramide program and could be the most significant transformational step we have taken to date in executing on our strategy to expand Ceapro’s business model towards becoming a biopharmaceutical company with the potential to provide an innovative product into very large markets. On the technical side, we are very pleased with the final formulation of avenanthramide powder, which has been produced in house using our unique chromatographic purifying technology and additionally with the final tablet developed with Corealis Pharma Inc, a Laval-based specialty pharmaceutical company. We are extremely grateful to be working with the expert team led by Dr. Tardif at MHI and MHICC, who shares the focus on Ceapro’s contemplated sector of inflammation-based diseases, metabolic syndrome and other lifestyle diseases,” added Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro.
