Cardiol Therapeutics Inc. announced that all collaborating research centers have been initiated and are eligible to enroll patients in ARCHER, the Company's Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx?, as well as its impact on myocardial recovery, in patients presenting with acute myocarditis. ARCHER is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel. The ARCHER trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence.

The trial is now enrolling patients at over 35 pre-eminent cardiovascular research centers in North America, France, Brazil and Israel. The co-primary outcome measures of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance imaging measures: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. The Company believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States and the European Union.

Orphan drug designation programs have been created to provide the sponsors of a drug significant incentives, including periods of prolonged marketing exclusivity and exemptions from certain fees, to develop treatments for rare diseases. Products with orphan drug designation also frequently qualify for accelerated regulatory review.