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Cardiol Therapeutics Enrolls First Patient in Pivotal Phase III MAVERIC Trial in Recurrent Pericarditis
Designed to assess the impact of CardiolRx™ on preventing episodes of recurrent pericardit...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Cardiol Therapeutics Enrolls First Patient in Pivotal Phase III MAVERIC Trial in Recurrent PericarditisDesigned to assess the impact of CardiolRx™ on preventing episodes of recurrent pericarditis, the first patient has been randomized by Northwestern University in Chicago.Based on a successful end-of-Phase II meeting with the US FDA and subject to MAVERIC outcomes, Cardiol believes the results from MAVERIC will support a New Drug Application.Data from Cardiol's Phase II MAvERIC-Pilot study presented at the American Heart Association Scientific Sessions 2024 showed that pericarditis patients treated with CardiolRx™ experienced marked and rapid reductions in pericarditis pain and inflammation, and a substantial reduction in the number of pericarditis recurrences per year.Recurrent pericarditis is a debilitating heart condition that results in chest pain, shortness of breath and fatigue, physical limitations, reduced quality of life, and hospitalizations.CardiolRx™, which has been granted US FDA Orphan Drug Designation for this indication, is a small molecule oral drug targeting inflammasome pathway activation that is central to the development and progression of pericarditis.Toronto, Ontario--(Newsfile Corp. - April 16, 2025) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) (\"Cardiol\" or the \"Company\"), a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announced today that Northwestern University has enrolled the first patient in the pivotal Phase III MAVERIC trial (\"MAVERIC\") evaluating Cardiol's lead drug candidate CardiolRx™ for the prevention of recurrent pericarditis. This multi-center, randomized, double-blind, placebo-controlled trial is designed to definitively assess the impact of CardiolRx™ on preventing recurrent pericarditis in patients at high risk for disease relapse and to support regulatory approval.MAVERIC is currently being initiated at pre-eminent cardiovascular clinical research sites throughout the United States under an Investigational New Drug application authorized by the United States Food and Drug Administration (\"US FDA\"). The MAVERIC Program and Phase III leadership comprises an independent committee of international thought leaders in pericardial disease and clin...