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Cardiol Therapeutics Inc, a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announced topline results from ARCHER, the company's phase II clinical trial in patients with acute myocarditis. In the two primary endpoints - extracellular volume (ECV) and global longitudinal strain (GLS) - CardiolRx showed a notable improvement in ECV (p = 0.0538) compared to placebo following 12 weeks of double-blind therapy, with no significant difference observed in GLS in a population that had preserved left ventricular (LV) function at baseline.
The reduction in ECV was associated with improvements over placebo in multiple pre-specified cardiac magnetic resonance imaging (CMR) endpoints, including a significant reduction in LV mass. The ARCHER trial results provide compelling clinical proof of concept for CardiolRx and strongly support advancing the clinical development of CardiolRx and CRD-38 in cardiomyopathies, heart failure, and myocarditis. Consistent with findings from Cardiol's phase II MAvERIC trial in recurrent pericarditis, CardiolRx was shown to be safe and well tolerated. The ARCHER results have been submitted for presentation at an upcoming scientific meeting and will be submitted for publication.
"On behalf of the ARCHER Steering Committee, I would like to extend our sincere gratitude to the patients who participated in the study; to their families and caregivers for their invaluable support; and to the clinical trial site investigators and staff, members of the international Steering Committee, and the Data and Safety Monitoring Committee, whose exemplary efforts in patient recruitment, clinical care, trial execution, monitoring, and oversight were instrumental in achieving the compelling findings of the ARCHER trial," said Dr. Dennis M. McNamara, Professor of Medicine at the University of Pittsburgh, Director of the Center for Heart Failure Research at the University of Pittsburgh Medical Center, and Chair of the ARCHER Steering Committee. "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."
Dr. Leslie T. Cooper, Jr., the Elizabeth C. Lane, and M. Nadine Zimmerman, Professor of Internal Medicine at the Mayo Clinic in Jacksonville, Florida, and Co-Chair of the Steering Committee for the ARCHER trial, added, "ARCHER was an important, well-designed, and well-executed clinical trial. The intriguing findings reinforce our original hypothesis that pharmaceutically manufactured cannabidiol can attenuate myocardial inflammation and edema. 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 remodeling, including the growing challenge of immune checkpoint inhibitor-induced myocarditis which can be fatal."
"We are delighted with the ARCHER trial results," said David Elsley, President and CEO of Cardiol Therapeutics. "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. 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."
ARCHER is a phase II multi-national, randomized, double-blind, placebo-controlled trial investigating the safety, tolerability, and impact of CardiolRx on myocardial recovery in patients presenting with acute myocarditis. The design and rationale for ARCHER were published on June 27, 2024, in the journal ESC Heart Failure.
The study enrolled 109 patients from leading cardiovascular research centers in the United States, France, Brazil, and Israel. The two primary outcome measures of the trial, which were evaluated following 12 weeks of double-blind therapy, consist of cardiac magnetic resonance imaging parameters: extra-cellular volume and global longitudinal strain, which assess myocardial function and tissue characteristics associated with fibrosis and inflammation.
Acute myocarditis is an inflammatory condition of the heart muscle (myocardium) characterized by chest pain, shortness of breath at rest or during activity, fatigue, rapid or irregular heartbeat (arrhythmias), and light-headedness or the feeling one might faint. The disease is an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people under 35 years of age. Viral infection is the most common cause of myocarditis; however, it can also result from bacterial infection, commonly used drugs, and mRNA vaccines, as well as therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors. There are no FDA-approved drug therapies for acute myocarditis. Patients hospitalized with the condition experience an average seven-day length of stay and a 4 - 6% risk of in-hospital mortality, with average hospital charge per stay estimated at $110,000 in the United States.
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