Cardiol posts results from Archer myocarditis trial

Executive Summary

• Cardiol Therapeutics announced top-line results from the Phase II Archer trial of CardiolRx in patients with acute myocarditis, demonstrating a notable improvement in the primary endpoint of extracellular volume (ECV) compared to placebo.
• The reduction in ECV was associated with significant improvements in multiple prespecified cardiac magnetic resonance imaging (CMR) endpoints, including a significant reduction in left ventricular (LV) mass.
• The results provide clinical proof of concept for CardiolRx, supporting the advancement of its clinical development in cardiomyopathies, heart failure, and myocarditis, while confirming the drug was safe and well-tolerated.

Key Details

• Trial Design: Phase II, multinational, randomized, double-blind, placebo-controlled trial.
• Patient Population: 109 patients with acute myocarditis enrolled from centers in the United States, France, Brazil, and Israel.
• Primary Endpoints:
  • Extracellular Volume (ECV): Showed notable improvement favoring CardiolRx over placebo (p = 0.0538) following 12 weeks of double-blind therapy.
  • Global Longitudinal Strain (GLS): No significant difference observed compared to placebo in the population with preserved left ventricular function at baseline.
• Secondary/CMR Findings: Reduction in ECV was associated with improvements across multiple prespecified CMR endpoints, including a significant reduction in left ventricular (LV) mass.
• Safety Profile: CardiolRx was shown to be safe and well-tolerated, consistent with findings from the Phase II Maveric trial in recurrent pericarditis.
• Development Strategy: Results support advancing the clinical development of CardiolRx and CRD-38 in cardiomyopathies, heart failure, and myocarditis.
• Publication Status: Results have been submitted for presentation at an upcoming scientific meeting and for publication.
• Context: Acute myocarditis is a leading cause of sudden cardiac death in people under 35, with no FDA-approved drug therapies currently available.

Notable Quotes

• Dr. Dennis M. McNamara, Chair of the Archer Steering Committee: "The results offer exciting new insights into the treatment of acute myocarditis and strongly support advancing the clinical development of this novel therapeutic approach for inflammatory cardiac conditions, including myocarditis and heart failure."
• Dr. Leslie T. Cooper Jr., Co-Chair of the Archer Steering Committee: "Archer's results provide sound rationale for advancing the clinical development of this novel therapy in conditions of the myocardium characterized by edema, fibrosis and remodelling, including the growing challenge of immune checkpoint inhibitor-induced myocarditis which can be fatal."
• David Elsley, President and CEO: "We are delighted with the Archer trial results... we now look forward to integrating the Archer findings into our broader clinical development strategy and business development initiatives-supporting the continued advancement of CardiolRx and CRD-38 as potential treatments for inflammatory cardiac disorders."