Cardiol Therapeutics Inc. announced it has expanded its MAVERIC phase III trial enrollment to 150 patients, following a recommendation from the Steering Committee. The trial, originally targeting 110 participants, now includes an additional 40 patients randomized 1:1 to receive either CardiolRx or a placebo. The study evaluates CardiolRx’s potential to lower the risk of pericarditis recurrence in patients with recurrent pericarditis. The primary endpoint will measure the time to a first new episode of recurrence, while secondary outcomes include the proportion of patients free from recurrence by the study’s conclusion.
CardiolRx, a subcutaneous formulation, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for treating recurrent pericarditis. The company’s existing capital is sufficient to fund the trial through mid-2027, with topline results now expected in the second half of that year—up from an earlier guidance of Q1 2027. The trial’s cash runway extends into the first quarter of 2028, reflecting ongoing operational efficiency.
David Elsley, President and CEO of Cardiol Therapeutics, noted in a statement that early blinded data from the trial show a lower recurrence rate than anticipated, an observation he attributed to no changes in clinical practice. The expansion aims to strengthen the trial’s statistical power and provide a more robust assessment of CardiolRx’s efficacy in this unmet medical need.
