A Phase III clinical trial testing a cannabidiol (CBD) formulation for recurrent pericarditis is being expanded after a blinded review found fewer disease recurrences than researchers had expected.
Cardiol Therapeutics announced today that its MAVERIC trial has enrolled 110 patients, reaching its original recruitment target ahead of schedule. The company now plans to increase enrollment to as many as 150 participants following a recommendation from the trial’s steering committee.
The randomized, double-blind, placebo-controlled trial is evaluating CardiolRx, a pharmaceutically manufactured oral cannabidiol solution, in adults with recurrent pericarditis, an inflammatory condition affecting the sac surrounding the heart. Participants are randomly assigned 1:1 to receive CardiolRx or a placebo.
According to the company, a blinded review of recurrence events among participants found a lower rate of pericarditis recurrence than had been anticipated when the trial was designed.
Because the study remains blinded, researchers do not yet know whether the fewer-than-expected recurrences occurred primarily among patients receiving CBD, those receiving placebo or both groups. The finding therefore cannot currently be interpreted as evidence that CardiolRx reduced recurrence risk.
The lower overall event rate does, however, create a statistical issue for the trial: researchers need enough recurrence events to reliably determine whether there is a meaningful difference between the treatment and placebo groups. Expanding enrollment is intended to increase the number of events available for the final analysis while preserving the study’s planned statistical power.
“A blinded review of events in MAVERIC patients who have been randomized 1:1 to either CardiolRx or placebo shows a lower level of pericarditis recurrence than anticipated,” said Cardiol Therapeutics President and CEO David Elsley, who called the observation encouraging and said the company was not aware of changes in routine clinical practice that would explain it.
The trial’s primary endpoint is the amount of time until a participant experiences a first new episode of recurrent pericarditis. Researchers will also examine the proportion of patients who remain free of another episode through the end of the study.
The Phase III trial follows an earlier Phase II study in which CardiolRx was associated with substantial reductions in pericarditis pain and inflammation. That study also reported a decrease in the annualized number of pericarditis episodes, although it was an open-label study without a placebo control. Its findings were published this year in the Journal of the American Heart Association.
CardiolRx has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of pericarditis, including recurrent pericarditis. It is not currently FDA-approved.
With the additional enrollment, Cardiol Therapeutics now expects topline Phase III results in mid-2027, later than its previous expectation of the first quarter of 2027.
