Ceapro Inc. announced the initiation of its Phase 1 study evaluating its product, Avenanthramides, for potential applications in managing conditions related to inflammation. Avenanthramides, di-phenolic compounds found exclusively in oats, have garnered significant interest due to their suggested bioactivities, including potent antioxidant and anti-inflammatory effects both in vitro and in vitro. This Phase 1-2a study ("AvenActive") 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 avenanthramide.

72 healthy subjects will be enrolled in the Phase 1 portion of the trial. The single ascending dose (SAD) arm will include 6 cohorts of 8 healthy subjects, while the multiple ascending dose (MAD) arm will include 3 cohorts of 8 healthy subjects. Following the Phase 1 portion, pending successful results, the AvenActive protocol also includes a Phase 2a portion for patients presenting evidence of mild to moderate inflammation.

24 patients would be enrolled in the Phase 2a portion. Dr. Jean-Claude Tardif's team is now actively screening healthy subjects for the first SAD cohort. Subjects will be under observation in a clinical setting and initial dosing is anticipated in early December 2023.

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. Published data has indicated that polyphenols, such as avenanthramides, may act as modifiers of signal transduction pathways, exhibiting beneficial effects.

These natural compounds are known to express anti-inflammatory activity by modulating the expression of proinflammatory genes, including cyclo-oxygenase, lipoxygenase, nitric oxide synthases, and key cytokines. The AvenActive study will focus on evaluating biomarkers of inflammation in blood, with a particular emphasis on pro-inflammatory cytokines, chemokines, and other inflammatory markers such as high sensitivity C-reactive protein. It houses the largest cardiology research center in Canada, the largest cardiovascular prevention center in the country, and the largest cardiovascular genetics center in Canada.

The Institute is affiliated with the Universite de Montreal and has more than 2000 employees, including 245 physicians and more than 85 researchers.