Cardiol Therapeutics Publishes Phase II Recurrent Pericarditis Data in JAHA

Cardiol Therapeutics announced the publication of its Phase II MAvERIC study results in the Journal of the American Heart Association (JAHA). The study demonstrated that its lead drug candidate, CardiolRx, was associated with rapid and sustained reductions in pericarditis pain and inflammation, along with a substantial decrease in pericarditis episodes per year and a favorable safety profile.

The publication makes available the full body of peer-reviewed Phase II evidence, including findings previously presented at American Heart Association scientific sessions. The President and Chief Executive Officer of Cardiol Therapeutics stated that the publication provides comprehensive details of clinically important reductions in pain, inflammation, and recurrences with CardiolRx, a favorable safety and tolerability profile, and its potential to offer a non-immunosuppressive treatment for patients with recurrent disease. These results directly informed the design of the pivotal Phase III MAVERIC trial, which is now nearing full enrollment.

MAVERIC is a randomized, double-blind, placebo-controlled study evaluating CardiolRx for reducing the risk of pericarditis recurrence. The Phase II study enrolled patients with a high baseline disease burden. Recurrent pericarditis is an inflammatory disease of the pericardium associated with debilitating chest pain, shortness of breath, and fatigue, and can lead to physical limitations and reduced quality of life. The U.S. FDA has granted Orphan Drug Designation to CardiolRx for the treatment of pericarditis, including recurrent pericarditis.

Cardiol Therapeutics is also advancing the ARCHER program studying CardiolRx in acute myocarditis, and developing a novel subcutaneous formulation, CRD-38, for heart failure.