FULL DISCLOSURE: Cardiol Therapeutics is a sponsor of theDeepDive.ca.
Cardiol Therapeutics (TSX: CRDL) (NASDAQ: CRDL) has released topline results from their phase two ARCHER trial targeting patients with acute myocarditis. The 12 week long study saw positive results for the two targeted primary endpoints, supporting the advancement of development of both CardiolRx™ and CRD-38 for the treatment of cardiomyopathies, heart failure and myocarditis.
“We are delighted with the ARCHER trial results. We initiated this ambitious study—focused on a potentially life-threatening cardiac disorder for which there is no established standard of care—to further investigate the therapeutic potential of CardiolRx in inflammatory heart disease. We are thrilled to observe improvements in multiple CMR measures associated with diagnosis, prognosis, and clinical outcomes,” commented Cardiol CEO David Elsley.
The ARCHER study targeted two primary endpoints, extracellular volume (ECV) and global longitudinal strain (GLS). The trial demonstrated that CardiolRx™ showed a notable improvement in ECV (p = 0.0538) relative to placebo after a 12 week long double-blind therapy. While no significant difference was observed in GLS in a population that had preserved left ventricular function at baseline.
Reductions exhibited in ECV are said to have been associated with improvements over placebo in multiple pre-specified cardiac magnetic resonance imaging endpoints, which includes a significant reduction in left ventricular mass. Furthermore, CardiolRx™ was shown to be safe and well tolerated, which is consistent with findings from the Phase II MAvERIC trial in recurrent pericarditis.
“As we continue to advance our lead clinical program, the pivotal Phase III MAVERIC trial in recurrent pericarditis, 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,” continued Elsley.
WATCH: A Heart Disease Cure For Pericarditis? Phase 3 Trial Advances | David Elsley – Cardiol Therapeutics
The ARCHER study was designed to investigate the safety, tolerability, and impact of CardiolRx™ on myocardial recovery in patients with acute myocarditis. The multi-national, randomized, double-blind, placebo-controlled study enrolled 109 patients from leading cardiovascular research centers across four countries, including the United States. The two primary endpoints were selected to assess myocardial function and tissue characteristics associated with fibrosis and inflammation.
“I commend Cardiol for undertaking this important trial that investigated the biological effects of pharmaceutically manufactured cannabidiol in acute myocarditis. 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. I look forward to collaborating with my colleagues on the Steering Committee as we prepare for the presentation and publication of the comprehensive ARCHER trial data,” added Dr. Dennis M. McNamara, Professor of Medicine at the University of Pittsburgh.
Results from the study have been submitted for presentation at an upcoming scientific meeting, and will then be submitted for publication.
Cardiol Therapeutics last traded at $1.53 on the TSX.
FULL DISCLOSURE: Cardiol Therapeutics is a client of Canacom Group, the parent company of The Deep Dive. Canacom Group is currently long the equity of Cardiol Therapeutics. The author has been compensated to cover Cardiol Therapeutics on The Deep Dive, with The Deep Dive having full editorial control. Not a recommendation to buy or sell. We may buy or sell securities in the company at any time. Always do additional research and consult a professional before purchasing a security.
