Cardiol Therapeutics Inc. announced on July 22, 2025, the database lock for ARCHER, its Phase II multi-national, randomized, double-blind, placebo-controlled trial. This trial investigates CardiolRx on myocardial recovery in patients with acute myocarditis. Database lock is a critical step that enables statistical analysis, unblinding, and the reporting of topline results.
Topline results from the ARCHER trial are now expected within the next two weeks, generating anticipation for key clinical data. David Elsley, President and CEO, stated that these results are expected to further guide the company's broader development strategy in heart diseases where fibrosis plays a key role. Acute myocarditis is a serious and underserved cardiovascular condition with no approved pharmacological therapy.
The ARCHER study enrolled over 100 patients from leading cardiovascular research centers across the United States, France, Brazil, and Israel. The primary outcome measures, evaluated after 12 weeks of therapy, include cardiac magnetic resonance imaging parameters such as global longitudinal strain and extra-cellular volume, which are recognized prognostic markers in myocarditis patients.
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