Cardiol eclipses 50% patient enrolment in Maveric trial

Executive Summary

• Cardiol Therapeutics Inc. has surpassed the 50% patient enrollment milestone in its pivotal Phase III Maveric trial for CardiolRx, a treatment for recurrent pericarditis.
• The trial is currently active in the United States with more than 15 leading cardiovascular centers, with additional sites being activated in Europe and Canada to accelerate enrollment.
• Full enrollment for the approximately 110-patient trial is expected in Q2 2026.

Key Details

• Trial Status: Phase III, randomized, double-blind, placebo-controlled, multicentre international trial.
• Enrollment Milestone: Surpassed 50% patient enrollment.
• Current Sites: Clinical trial infrastructure is fully operational in the United States with more than 15 leading cardiovascular centers actively enrolling patients.
• Expansion: Activation of additional top-tier clinical sites in Europe and Canada is underway.
• Enrollment Target: Approximately 110 patients across some 25 leading cardiovascular research centers in the United States, Canada, and Europe.
• Projected Timeline: Full enrollment expected in Q2 2026.
• Primary Endpoint: Freedom from a new episode of recurrent pericarditis, assessed after six months of double-blind treatment.
• Secondary Endpoints: Percentage of days with no or minimal pericarditis pain, changes in pericarditis pain scores, and changes in the inflammatory biomarker C-reactive protein (CRP).
• Background Data: The Phase III trial builds on positive results from the Phase II Maveric-Pilot study, which showed rapid and sustained reductions in pericarditis pain, inflammation, and recurrence events per year, with CardiolRx shown to be safe and well-tolerated.
• Regulatory Status: The U.S. Food and Drug Administration has granted orphan drug designation to CardiolRx for the treatment of pericarditis, including recurrent pericarditis.

Notable Quotes

• "Surpassing 50-per-cent enrolment in Maveric is an important milestone for our phase III program and reflects both the high unmet medical need in recurrent pericarditis and the confidence investigators have in the scientific rationale and rigorous design of this pivotal trial," said Dr. Andrew Hamer, chief medical officer and head of research and development at Cardiol Therapeutics.
• "The continued expansion of the Maveric program underlines the importance of evaluating additional treatment options for use earlier in the recurrent pericarditis treatment paradigm -- before patients are exposed to prolonged corticosteroid use or immunosuppressive biologics such as interleukin-1 inhibitors," said David Elsley, president and chief executive officer.