Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) announced that it has reached its target enrollment of 100 patients in the ARCHER trial, a Phase II randomized, double-blind, placebo-controlled study evaluating CardiolRx for myocardial recovery in patients with acute myocarditis.
"We are pleased to have achieved our target patient enrollment in the ARCHER trial, which reflects the commitment and dedication of our clinical collaborators and participating patients," said Andrew Hamer, chief medical officer at Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL).
"Reaching this milestone is integral to enhancing our understanding of the therapeutic impact of CardiolRx in acute myocarditis, a debilitating and potentially life-threatening inflammatory heart disease."
Topline results from the ARCHER trial are expected early next year, and the data is anticipated to offer key insights into the effects of CardiolRx on myocardial recovery. Cardiol expects these findings to complement data from its MAvERIC Phase II study on recurrent pericarditis, which will be presented in November at the American Heart Association Scientific Sessions 2024.
The ARCHER trial, conducted at cardiovascular research centers across the United States, Canada, France, Brazil, and Israel, focuses on evaluating the safety, tolerability, and impact of CardiolRx on myocardial recovery. The primary outcome measures include left ventricular function and myocardial edema/fibrosis, while additional outcomes will assess survival, freedom from major cardiovascular events, and changes in cardiac biomarkers.
Acute myocarditis, an inflammatory condition of the heart muscle, can lead to chest pain, shortness of breath, and arrhythmias. The condition is a leading cause of sudden cardiac death in people under 35 and can result from viral or bacterial infections, as well as certain drugs and therapies. There are currently no FDA-approved treatments for acute myocarditis.
Cardiol sees potential for developing a new therapy for acute myocarditis, with opportunities to seek orphan drug designation in the United States and European Union, which could provide marketing exclusivity and regulatory benefits.