CRDL News & Events

Cardiol Therapeutics announced the continued expansion of its pivotal Phase III MAVERIC trial in the U.S., with the planned activation of up to seven additional clinical centers. Patient enrollment in MAVERIC surpassed the 50% threshold in early January and has now reached 75%. Target recruitment is anticipated by the end of Q2, with the potential to extend into Q3 to accommodate patient enrollment from additional clinical sites. MAVERIC is a randomized, double-blind, placebo-controlled pivotal Phase III trial evaluating CardiolRx for the prevention of disease recurrence in patients with recurrent pericarditis. The study is designed to enroll approximately 110 patients. MAVERIC was designed with input from the FDA, with alignment on trial design achieved at an end-of-Phase II meeting in April 2025. The first patient was randomized at Northwestern University in April 2025. MAVERIC builds on the clinical evidence established in the Phase II MAvERIC study, which demonstrated that CardiolRx produced rapid and sustained reductions in pericarditis pain and inflammation, along with a substantial decrease in recurrent episodes per year.

Keeping a Buy rating on Cardiol Therapeutics, Roth Capital notes that top-line results for the ARCHER for Acute Myocarditis study were very encouraging. On the primary endpoint of left ventricular extracellular volume it showed a notable improvement favoring CardiolRx over placebo, but just missed statistical significance, which is encouraging for a larger trial as so far, no other trial has shown improvement here. Roth also notes that the company did not meet the other independent primary endpoint of improvement in Global Longitudinal Strain, but this was as expected as it was a relatively high bar on patients that were relatively healthy with preserved left ventricle function. The firm thinks these results are good enough to attract a larger partner to run a much larger heart failure trial as well as support a larger pivotal trial for acute myocarditis.