Health Canada has granted clearance to Ceapro to initiate the Phase I/IIa clinical trial of its pharmaceutical-grade tablet of avenanthramide as a potential anti-inflammatory product.
The first-in-human, randomised, placebo-controlled, double-blind, adaptive trial will assess the safety, efficacy, tolerability and bioavailability of avenanthramide’s single and multiple ascending oral doses.
The trial will enrol nearly 96 healthy participants and individuals with low-grade inflammation.
As per the subject’s response, dosages varying from 30mg to 960mg will be analysed.
Participant recruitment is expected to begin early next year.
The trial will also analyse the impact of avenanthramide on plasma markers of various cardiometabolic indicators and inflammatory biomarkers, to potentially offer preliminary signals on the product formulation’s activity.
The company will carry out the trial along with the Montreal Heart Institute led by its Montreal Health Innovations Coordinating Center.
Ceapro president and CEO Gilles Gagnon said: “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, a Laval-based specialty pharmaceutical company.”
In August this year, the company signed a research project extending the ongoing partnership with McMaster University for developing an inhalable Immuno-therapeutic/-prophylactic for Covid-19-induced lung fibrosis.