Cardiol Therapeutics Presents Phase II ARCHER Trial at 2024 Heart Failure Congress

Cardiol Therapeutics Inc., a clinical-stage life sciences company, recently announced significant advancements in its Phase II randomized, double-blind, placebo-controlled trial evaluating CardiolRx™ for the treatment of acute myocarditis. The trial, known as the ARCHER study, was featured in an oral presentation at the World Congress on Acute Heart Failure 2024, held from May 11 to 14 in Lisbon, Portugal. This congress is the annual gathering of the Heart Failure Association under the European Society of Cardiology.

The presentation, led by Univ.-Prof. Dr. med. Carsten Tschöpe from the Berlin Institute of Health - Charité, highlighted the trial’s design, rationale, and blinded baseline data from the first 50 patients randomized in the study. These insights were shared on behalf of the ARCHER steering committee, comprising renowned experts in heart failure and myocarditis from international centers of excellence. Concurrently, the journal ESC Heart Failure has accepted a manuscript detailing the trial's rationale and design for publication.

David Elsley, President and CEO of Cardiol Therapeutics, emphasized that the acceptance to present at such a prestigious conference and the pending publication in a reputable journal underscores the cardiology community’s interest in novel treatments for acute myocarditis. Currently, there are no approved therapies for this condition by either European or US regulatory authorities. The baseline data from the first participants in the ARCHER trial indicate expected demographics and show low variability in primary and secondary outcome measures, reflecting acute myocarditis patients who could potentially benefit from CardiolRx™ therapy.

Elsley also noted that patient recruitment has picked up pace, driven by increased global awareness of myocarditis and strong support from clinical collaborators and patients. The ARCHER trial has now surpassed 85% of its target enrollment and is on track to provide valuable data that might enhance the understanding of CardiolRx™'s therapeutic potential. This could complement findings from the more advanced MAvERIC-Pilot Phase II study for recurrent pericarditis, which is expected to release topline results by early June 2024.

The ARCHER trial aims to enroll 100 patients across premier cardiovascular research centers in the United States, Canada, France, Brazil, and Israel. The primary outcomes will be evaluated over 12 weeks of therapy and include cardiac magnetic resonance imaging measures for left ventricular function and myocardial edema/fibrosis, both pivotal in predicting long-term prognosis in acute myocarditis patients. Additional efficacy measurements will assess left ventricular ejection fraction, survival, freedom from major cardiovascular events, symptom resolution, and changes in biomarkers related to cardiac function and inflammation.

Acute myocarditis is an inflammatory condition of the heart muscle, often presenting with symptoms like chest pain, shortness of breath, fatigue, arrhythmias, and dizziness. It is a significant cause of acute and severe heart failure and sudden cardiac death in individuals under 35. The condition frequently results from viral infections but can also be caused by bacterial infections, certain medications, mRNA vaccines, and cancer therapies. Hospitalized patients face an average stay of seven days and a 4-6% risk of in-hospital mortality, with an estimated cost of $110,000 per stay in the United States.

Cardiol Therapeutics is dedicated to developing anti-inflammatory and anti-fibrotic therapies for heart diseases. Their leading drug candidate, CardiolRx™ (a cannabidiol oral solution), is under clinical development for heart disease treatment. The company has received authorization from the US FDA to conduct clinical studies on CardiolRx™ for recurrent pericarditis and acute myocarditis. Additionally, Cardiol is developing CRD-38, a new subcutaneously administered drug aimed at treating heart failure.

Cardiol Therapeutics continues to advance its clinical programs with the goal of addressing significant unmet needs in cardiovascular medicine.