Cardiol Therapeutics Inc. (NASDAQ: CRDL) is making strides in the development of CardiolRx™, a cannabidiol oral solution, for the treatment of inflammatory heart diseases. Recent milestones include the completion of patient enrollment in a Phase II trial for acute myocarditis and promising data from a Phase II study in recurrent pericarditis.
ARCHER Trial Completes Enrollment
Cardiol Therapeutics announced the completion of target patient enrollment in its Phase II ARCHER trial. This randomized, double-blind, placebo-controlled trial is evaluating the impact of CardiolRx™ on myocardial recovery in 100 patients with acute myocarditis across multiple countries, including the United States, Canada, France, Brazil, and Israel. The primary outcome measures, assessed after 12 weeks of therapy, include cardiac magnetic resonance imaging (MRI) measures of left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extracellular volume). These measures are known to predict the long-term prognosis of patients with acute myocarditis.
Acute myocarditis, an inflammatory condition of the heart muscle, is characterized by symptoms such as chest pain, shortness of breath, and arrhythmias. It is a leading cause of sudden cardiac death in people under 35 years of age. Viral infections, bacterial infections, drugs, and mRNA vaccines can trigger the condition. Currently, there are no FDA-approved therapies for acute myocarditis, and hospitalization for the condition involves an average stay of seven days with a 4-6% risk of in-hospital mortality. The average hospital charge per stay is estimated at $110,000 in the United States.
Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development, stated, "Reaching this milestone is integral to enhancing our understanding of the therapeutic impact of CardiolRx™ in acute myocarditis... With topline results expected early next year, the data from the ARCHER trial is anticipated to offer key insights concerning the effects of CardiolRx™ on myocardial recovery."
MAvERIC-Pilot Study Shows Positive Results in Recurrent Pericarditis
Cardiol Therapeutics also announced the completion of its MAvERIC-Pilot study, a Phase II open-label trial investigating the impact of CardiolRx™ in patients with symptomatic recurrent pericarditis. The full clinical data from this study were presented at the American Heart Association Scientific Sessions 2024 on November 18. The study involved 27 adult participants at eight clinical sites across the United States.
The primary efficacy endpoint of the MAvERIC-Pilot study was the change in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS). Results showed marked reductions in pericarditis pain and inflammation at 8 weeks. Additional endpoints included freedom from pericarditis recurrence during an 18-week extension period, 26-week pericarditis pain score, inflammatory marker levels, and safety and tolerability outcomes.
Recurrent pericarditis, an inflammation of the pericardium, is characterized by symptoms such as chest pain, shortness of breath, and fatigue. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and primarily used as a third-line intervention. Approximately 38,000 patients in the United States experience at least one recurrence annually, with hospitalization costs ranging from $20,000 to $30,000 per stay.
Advancing CardiolRx™ Development
Building on the positive results from the MAvERIC-Pilot study, Cardiol Therapeutics plans to expand the MAVERIC clinical development program. The company will advance CardiolRx™ into a late-stage clinical trial, MAVERIC-2, to evaluate its impact in recurrent pericarditis patients following cessation of interleukin-1 (IL-1) blocker therapy. This randomized, double-blind, placebo-controlled Phase II/III trial will involve approximately 110 patients.
The primary clinical objective of MAVERIC-2 will be to assess the impact of CardiolRx™ versus placebo on freedom from a new episode of recurrent pericarditis. Other endpoints include time to a new episode of pericarditis recurrence and changes in patient-reported pericarditis chest pain score and the inflammatory marker C-reactive protein (CRP).
David Elsley, President & CEO of Cardiol Therapeutics, noted, "MAVERIC-2 provides an exciting opportunity to expand the market potential for CardiolRx through the execution of a cost-effective study and potentially provides a path for an accelerated regulatory approval timeline."
Cardiol Therapeutics is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure, a condition affecting more than 64 million people globally and associated with healthcare costs exceeding $30 billion annually in the US alone.
CardiolRx™ Mechanism of Action
CardiolRx™ is recognized to inhibit activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure. By targeting this pathway, CardiolRx™ offers a potential non-immunosuppressive therapeutic option for patients with inflammatory heart diseases.
With ongoing clinical trials and a strategic focus on addressing unmet medical needs, Cardiol Therapeutics is positioned to make a significant impact in the treatment of myocarditis, pericarditis, and heart failure.
