Cardiol Therapeutics Inc. has announced positive clinical results from its Phase II open-label MAvERIC-Pilot study, revealing that CardiolRx™ demonstrated sustained improvements in pericarditis pain and inflammation in patients with symptomatic recurrent pericarditis over a 26-week period. The data, presented at the American Heart Association Scientific Sessions 2024, supports the initiation of Phase III trials (MAVERIC-3) and the ongoing Phase II/III trial (MAVERIC-2) to further evaluate CardiolRx™ in treating recurrent pericarditis.
The MAvERIC-Pilot study enrolled 27 participants with an average age of 53 years, 67% of whom were female, across eight clinical sites in the United States. The average disease duration was 2.7 years, with patients experiencing an average of 5.8 pericarditis episodes per year prior to trial entry. Baseline pericarditis pain score averaged 5.8 out of 10, and the C-reactive protein (CRP) level averaged 2.0 mg/dL. The study consisted of an 8-week treatment period followed by an 18-week extension period, during which patients were weaned off baseline medications to assess pericarditis recurrence while on CardiolRx™ monotherapy.
Key Findings from MAvERIC-Pilot
Dr. S. Allen Luis, Co-Director of the Pericardial Diseases Clinic at the Mayo Clinic, highlighted that patients in the MAvERIC-Pilot study experienced clinically relevant and rapid reductions in both pericarditis pain and C-reactive protein levels that were maintained throughout the study. The results also demonstrated a substantial reduction in pericarditis episodes per year compared to the patients' historical event rate prior to the study. Treatment was safe and well-tolerated in this patient population.
David Elsley, President and CEO of Cardiol Therapeutics, emphasized that the compelling results from MAvERIC-Pilot showed that CardiolRx™ resulted in marked and rapid reductions in pericarditis pain and inflammation, as well as a striking decrease in pericarditis episodes per year. He believes that CardiolRx™ has the potential to offer a more accessible and non-immunosuppressive therapeutic option for pericarditis patients.
Study Design and Patient Population
Eligible patients for the MAvERIC-Pilot study were adults (≥18 years) with at least their third pericarditis episode, symptomatic pericarditis chest pain with a numerical rating scale (NRS) pain score ≥4, and either an elevated level of CRP ≥1 mg/dL or evidence of pericardial inflammation assessed by cardiac imaging. At baseline, patients were permitted to be receiving stable doses of concomitant medications for recurrent pericarditis, including non-steroidal anti-inflammatory drugs, colchicine, and/or oral corticosteroid therapy.
The Burden of Recurrent Pericarditis
Pericarditis, an inflammation of the pericardium, often results from a viral infection. Recurrent episodes can lead to debilitating chest pain, shortness of breath, and fatigue, significantly impacting patients' quality of life. In the United States, an estimated 38,000 patients experience at least one recurrence annually. Current treatment options are limited, with the only FDA-approved therapy being costly and primarily used as a third-line intervention.
Cardiol's Broader Clinical Program
Cardiol Therapeutics is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure. The company has received Investigational New Drug Application authorization from the US FDA to conduct clinical studies evaluating the efficacy and safety of CardiolRx™ in recurrent pericarditis and acute myocarditis. The ARCHER trial is a Phase II study in acute myocarditis.
