Cardiol Therapeutics (TSX: CRDL) has enrolled 110 patients in its pivotal Phase III MAVERIC trial, reaching its original recruitment target ahead of the end-of-September timeline the company had guided to.
Enrollment is not closing yet, however. The trial’s steering committee has recommended expanding the study to as many as 150 patients after a blinded review found fewer pericarditis recurrences than expected across the patient population.
Because the review was conducted blind, it cannot distinguish outcomes between the CardiolRx™ and placebo arms, into which patients are randomized 1:1. Cardiol nonetheless views the lower event rate as encouraging, noting it is not aware of any change in routine clinical practice that would account for it.
“Our planned enrollment expansion is designed to support the event count needed to preserve the trial’s planned statistical power and deliver a more robust assessment of CardiolRx™’s efficacy,” said President and CEO David Elsley.
The expansion comes at the cost of time. Topline results are now expected in mid-2027, compared with previous guidance of Q1 2027. Cardiol says existing capital will fund MAVERIC through completion, with its cash runway extending into Q1 2028.
RELATED: Cardiol Publishes Phase II MAVERIC Data in the Journal of the American Heart Association
MAVERIC is a randomized, double-blind, placebo-controlled, multi-center study evaluating CardiolRx™ for reducing the risk of recurrence in patients with recurrent pericarditis. The primary endpoint measures time to a first new recurrence episode, matching the endpoint used in the pivotal trial of the only FDA-approved therapy for the condition. The proportion of patients who remain recurrence-free at the end of the study will be assessed as a secondary endpoint.
The trial builds on the Phase II MAVERIC study, published in the Journal of the American Heart Association in July. That study associated CardiolRx™ with rapid and sustained reductions in pain and inflammation, fewer pericarditis episodes per year, and a favorable safety and tolerability profile.
CardiolRx™, a small-molecule drug that modulates inflammasome pathway activation, holds FDA Orphan Drug Designation for the treatment of pericarditis, including recurrent pericarditis.
Cardiol Therapeutics last traded at $2.43 on the TSX.
