Cardiol Therapeutics Announces Topline Results from the Phase II ARCHER Trial of CardiolRx(TM) in Acute Myocarditis

Core Insights - Cardiol Therapeutics announced topline results from the Phase II ARCHER trial of CardiolRx™ in patients with acute myocarditis, showing a notable improvement in extracellular volume (ECV) compared to placebo [2][4] - The trial demonstrated safety and tolerability of CardiolRx™, supporting its advancement in clinical development for cardiomyopathies, heart failure, and myocarditis [2][5] Clinical Trial Results - The primary endpoints of the ARCHER trial were ECV and global longitudinal strain (GLS), with ECV showing significant improvement (p = 0.0538) after 12 weeks of treatment [2][4] - Improvements in ECV were associated with reductions in multiple cardiac magnetic resonance imaging (CMR) endpoints, including a significant reduction in left ventricular (LV) mass [4][5] - The trial enrolled 109 patients across multiple countries, including the United States, France, Brazil, and Israel [5][8] Company Overview - Cardiol Therapeutics is focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease, with its lead drug candidate being CardiolRx™, a pharmaceutically manufactured cannabidiol oral solution [7][9] - The company has received FDA authorization for clinical studies evaluating CardiolRx™ in recurrent pericarditis and acute myocarditis, with ongoing Phase III trials [8][9] Industry Context - Acute myocarditis is a significant cause of heart failure and sudden cardiac death, particularly in individuals under 35 years of age, with no FDA-approved drug therapies currently available [6] - The healthcare costs associated with heart failure in the U.S. exceed $30 billion annually, highlighting the potential market for effective treatments [9]