Cardiol Therapeutics Inc. has successfully reached its target enrollment of 100 patients for its Phase II ARCHER trial, which investigates the efficacy of CardiolRx™ in treating acute myocarditis. The announcement was made on September 24, 2024, from the company’s headquarters in Toronto, Ontario.
The ARCHER trial is a randomized, double-blind, placebo-controlled study aimed at examining how CardiolRx™ can aid myocardial recovery in patients suffering from acute myocarditis. Andrew Hamer, Chief Medical Officer and Head of Research & Development at Cardiol Therapeutics, expressed satisfaction with this milestone. He noted that the achievement reflects the hard work of clinical collaborators and participating patients. Hamer emphasized the importance of this trial in understanding the therapeutic effects of CardiolRx™ on a condition that severely affects heart function and quality of life.
Topline results from the ARCHER trial are expected early next year.
Hamer anticipates that the data will provide valuable insights into how CardiolRx™ promotes myocardial recovery. He also mentioned that these findings will complement results from the MAvERIC Phase II study on recurrent pericarditis, with full results set to be presented at the American Heart Association Scientific Sessions in November.
Overview of The ARCHER Study Design
The design and rationale for the ARCHER trial were published in the journal ESC Heart Failure on June 27, 2024. This multinational study aims to evaluate both the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery in patients diagnosed with acute myocarditis. Patients are being recruited from leading cardiovascular research centers across the United States, Canada, France, Brazil, and Israel.
The primary outcome measures include two cardiac magnetic resonance imaging metrics: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extracellular volume). These measures are crucial as they have been shown to predict long-term outcomes for patients with acute myocarditis. Secondary efficacy outcomes will assess survival rates, freedom from major cardiovascular events, symptom resolution, and changes in biomarkers related to cardiac function and inflammation.
Implications for Heart Disease Treatment
The successful enrollment in the ARCHER trial highlights a growing interest in innovative treatments for acute myocarditis, a condition currently lacking approved therapies in both Europe and the United States. David Elsley, President and CEO of Cardiol Therapeutics, noted that the accelerating patient recruitment reflects increasing global awareness of myocarditis.
The results from this trial could significantly advance understanding of CardiolRx™’s potential as a treatment option for acute myocarditis.
The company is also looking forward to reporting topline results from its MAvERIC-Pilot study focused on recurrent pericarditis in early June 2024.
In summary, Cardiol Therapeutics is making strides in addressing acute myocarditis through its ARCHER trial. With patient enrollment complete and results anticipated soon, there is optimism about the potential impact of CardiolRx™ on heart disease treatment strategies.
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