Cardiol Therapeutics announced on April 16, 2025, that Northwestern University enrolled the first patient in its pivotal Phase III MAVERIC trial. This trial is designed to evaluate CardiolRx for the prevention of recurrent pericarditis. The multi-center, randomized, double-blind, placebo-controlled study aims to definitively assess CardiolRx's impact on preventing disease relapse in high-risk patients and support regulatory approval.
The MAVERIC trial is being initiated at prominent cardiovascular clinical research sites across the United States under an Investigational New Drug application authorized by the US FDA. Based on a successful end-of-Phase II meeting with the US FDA, Cardiol believes the results from MAVERIC will support a New Drug Application submission. This marks a significant step towards bringing CardiolRx to market for a debilitating heart condition.
Recurrent pericarditis is a challenging condition, and CardiolRx has been granted US FDA Orphan Drug Designation for this indication. The trial's primary objective is to assess freedom from a new episode of recurrent pericarditis at 24 weeks. This advancement follows positive data from Cardiol's Phase II MAvERIC-Pilot study, which showed marked reductions in pain and inflammation.
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