Cardiol Therapeutics has reported encouraging results from its Phase II MAvERIC-Pilot study, indicating that its anti-inflammatory therapy, CardiolRx, demonstrates sustained efficacy in treating symptomatic recurrent pericarditis. The findings, presented at the American Heart Association Scientific Sessions 2024, highlight significant improvements in pericarditis pain and inflammation, with benefits lasting throughout the 26-week trial.
MAvERIC-Pilot Study Details
The MAvERIC-Pilot study enrolled 27 patients with an average age of 53, who had a history of 5.8 pericarditis episodes annually over 2.7 years. At the start of the study, the average pain score was 5.8 out of 10, and the mean C-reactive protein (CRP) level, a key marker of inflammation, was 2.0 mg/dL.
Key Efficacy Outcomes
Significant improvements were observed during the trial. The mean pain score reduction was 3.7 points at the primary eight-week endpoint, with further improvement to 1.5 points by week 26. CRP levels normalized in 80% of patients with elevated baseline levels at week 8, with sustained reductions throughout the study. The annualized number of pericarditis episodes decreased from 5.8 prior to the trial to 0.9 during the study. Notably, researchers observed rapid pain resolution within approximately five days of initiating CardiolRx treatment.
Recurrence-Free Rates
An additional finding was that 71% of participants remained free from recurrence during the extension period after tapering off standard therapies, suggesting a potential for long-term benefit.
Expert Commentary
According to Dr. S. Allen Luis of the Mayo Clinic, who presented the findings, the results demonstrate substantial and clinically relevant reductions in pericarditis pain and inflammation. Cardiol's CEO, David Elsley, emphasized that the data underscore CardiolRx’s potential as a non-immunosuppressive therapy for tens of thousands of pericarditis patients.
Ongoing and Planned Trials
These results support the advancement of Cardiol's late-stage MAVERIC clinical development program, which includes the recently announced Phase II/III MAVERIC-2 trial and the planned MAVERIC-3 Phase III trial. David Elsley noted that undertaking both trials in parallel provides an opportunity for CardiolRx to address the unmet needs of patients in multiple segments of the pericarditis population.
With its ongoing and planned trials, Cardiol aims to address the unmet needs of patients across diverse pericarditis segments, potentially offering an innovative treatment pathway for this debilitating condition.
