Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) said all the research centers it is collaborating with on its ARCHER Phase 2 trial to study the safety, tolerability and impact on myocardial recovery of its investigative therapeutic CardiolRx in patients with acute myocarditis have been initiated and are eligible to enroll patients.
The company said that ARCHER is expected to enroll 100 patients at major cardiac centres in North America, Europe, Latin America, and Israel.
Recruitment is accelerating with full patient enrollment expected to be completed during the third quarter of 2024, six months ahead of schedule, the company said.
"This is a significant milestone in expanding the reach of ARCHER worldwide and contributing to evaluating the clinical potential of CardiolRx in acute myocarditis, an inflammatory condition of the heart muscle characterized by chest pain, impaired heart function, arrhythmias, and conduction disturbances," Cardiol chief medical officer and head of research and development Dr. Andrew Hamer said in a statement.
"The data generated from patients who enroll in ARCHER will provide important information in support of the use of CardiolRx as a novel small molecule therapeutic approach for this debilitating rare disease, which is an important cause of acute and fulminant heart failure and a leading cause of sudden cardiac death in people under 35 years of age, for which there are no approved therapies."
The trial was designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence, Cardiol said.
The co-primary outcome measures of the trial consist of cardiac magnetic resonance imaging measures, including left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict the long-term prognosis of patients with acute myocarditis.
Cardiol is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease.
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