Dr. Andrew Hamer reports

CARDIOL THERAPEUTICS COMPLETES PATIENT ENROLLMENT IN ITS PHASE II MAVERIC-PILOT STUDY INVESTIGATING CARDIOLRX(TM) FOR RECURRENT PERICARDITIS

Cardiol Therapeutics Inc. has completed patient enrolment in its phase II open-label pilot study (MAvERIC-pilot) investigating the safety, tolerability and efficacy of CardiolRx in patients with recurrent pericarditis. In addition, the company expects to report top-line results from MAvERIC-pilot in Q2 2024.

"Having achieved full patient enrolment, we are now positioned to announce high-level MAvERIC-pilot clinical trial data in the second quarter of this year. These results are expected to inform the design of a pivotal phase III clinical trial in recurrent pericarditis to underpin the potential regulatory approval of CardiolRx, which has recently been granted orphan drug designation by the United States FDA," said Andrew Hamer, Cardiol Therapeutics' chief medical officer and head of research and development. "We thank our clinical collaborators and participating patients and families for their continued interest and commitment. Their support is contributing to our understanding of the therapeutic profile of CardiolRx in this debilitating inflammatory heart disease associated with symptoms that adversely affect quality of life and physical activity."

MAvERIC-pilot (NCT05494788) is a phase II open-label pilot study investigating the tolerance, safety and effect of CardiolRx administered to patients with recurrent pericarditis. The study has completed enrolment of the planned target of 25 patients in the United States, and subject to fulfilling eligibility criteria, any patient currently in the screening process who agrees to participate in the study will also be enrolled and included in the final cohort. In addition to standard safety assessments, MAvERIC-pilot is designed to evaluate improvement in objective measures of this rare disease. The primary efficacy end point is the change, from baseline to eight 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 end points 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. Importantly, the study will also assess freedom from pericarditis recurrence.

Recurrent pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) that follows an initial episode (frequently resulting from a viral infection). Patients may have multiple recurrences. Symptoms include debilitating chest pain, shortness of breath and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only Food and Drug Administration-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States having experienced at least one recurrence is estimated at 38,000. Approximately 60 per cent of patients with multiple recurrences (greater than one) still suffer for longer than two years, and one-third are still impacted at five years. Hospitalization due to recurrent pericarditis is often associated with a six-to-eight-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.

About Cardiol Therapeutics Inc.

Cardiol Therapeutics is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The company's lead small-molecule drug candidate, CardiolRx (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits 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.

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