Toronto – September 23, 2026 -- Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has hit its 110-patient enrollment target for the pivotal Phase III MAVERIC trial ahead of its end-of-September guidance, and will now expand recruitment to as many as 150 patients.
Blinded review shows fewer recurrences than expected in pericarditis trial
A blinded review of patients randomized 1:1 to CardiolRxTM or placebo found a lower-than-anticipated rate of pericarditis recurrence, according to Cardiol. The MAVERIC Steering Committee recommended the enrollment increase to capture enough clinical events for a statistically robust efficacy read.
President and CEO David Elsley said the company is not aware of any change in routine clinical practice that would explain the reduced recurrence rate, calling the finding encouraging.
Topline data pushed to mid-2027 from prior Q1 2027 target
The expanded enrollment shifts the anticipated topline readout to mid-2027, three to six months later than the company's previous Q1 2027 guidance. Cardiol said existing capital is sufficient to complete the trial, with cash runway extending into Q1 2028.
Primary endpoint tracks time to first new recurrence episode
MAVERIC's primary efficacy analysis will measure time to a first new pericarditis recurrence, mirroring the endpoint used in the pivotal trial of the only FDA-approved therapy for the condition. A secondary endpoint will assess the proportion of patients remaining recurrence-free by study end.
MAVERIC (NCT06708299) is a randomized, double-blind, placebo-controlled, multi-center Phase III study evaluating CardiolRxTM, an anti-inflammatory small-molecule candidate that modulates inflammasome pathway activation. The U.S. FDA has granted CardiolRxTM Orphan Drug Designation for pericarditis, including the recurrent form of the disease.