Cardiol Therapeutics Inc. announced positive topline results from its Phase II ARCHER clinical trial in patients with acute myocarditis on August 6, 2025. CardiolRx demonstrated a notable improvement in left ventricular (LV) extracellular volume (ECV) (p = 0.0538) compared to placebo following 12 weeks of double-blind therapy. This reduction in ECV is a key measurement used to predict prognosis in myocarditis patients.
The reduction in ECV was associated with improvements across multiple pre-specified cardiac magnetic resonance imaging (CMR) endpoints, including a significant reduction in LV mass. While no significant difference was observed in global longitudinal strain (GLS) in a population with preserved LV function, the overall findings provide compelling clinical proof of concept for CardiolRx. The drug was also shown to be safe and well tolerated, consistent with previous findings.
David Elsley, President and CEO, expressed delight with the results, stating they support advancing the clinical development of CardiolRx and CRD-38 in cardiomyopathies, heart failure, and myocarditis. The ARCHER results have been submitted for presentation at an upcoming scientific meeting and will be submitted for publication. Acute myocarditis is a potentially life-threatening condition with no FDA-approved drug therapies.
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