Cardiol Therapeutics Inc. announced that Massachusetts General Hospital (Mass General) has been initiated and is eligible to enroll patients in MAvERIC-Pilot, the company's Phase II open-label pilot study, investigating the safety, tolerability, and efficacy of CardiolRxTM in patients with recurrent pericarditis. In addition to standard safety assessments, the study is designed to evaluate improvement in objective measures of this rare disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRxTM and to assess freedom from pericarditis recurrence. MAvERIC-Pilot is enrolling 25 patients at eight prominent medical research centers in the United States that specialize in pericarditis care.

The study recently surpassed 50% of its enrollment objective and is anticipated to complete patient recruitment during First Quarter 2024. The study Chairman is Allan L. Klein, MD, Director of the Center of Pericardial Diseases and Professor of Medicine, Heart and Vascular Institute, at the Cleveland Clinic. The primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale ("NRS").

The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the NRS score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation.