Cardiol Therapeutics' CardiolRx has shown positive results in a Phase II clinical trial for treating recurrent pericarditis. The MAvERIC-Pilot study, presented at the American Heart Association Scientific Sessions 2024, demonstrated significant improvements in pericarditis pain and inflammation, which were sustained throughout the 26-week study period.
The trial enrolled 27 participants across eight U.S. clinical sites. Key findings included a reduction in pain scores from 5.8 to 1.5 at week 26, normalization of C-reactive protein (CRP) levels in 80% of patients at week 8, and a decrease in pericarditis episodes from 5.8 to 0.9 per year. The data supports the advancement of CardiolRx into Phase II/III MAVERIC-2 and Phase III MAVERIC-3 trials.
Key Outcomes from MAvERIC-Pilot Study
The MAvERIC-Pilot study's primary endpoint focused on patient-reported pericardial pain, measured on an 11-point numerical rating scale. Results showed a mean reduction of 3.7, from 5.8 at baseline to 2.1 at week 8. The median time to pain resolution (defined as a score ≤ 2) was rapid, observed just 5 days after initiating CardiolRx treatment. This pain reduction was maintained throughout the trial, with a mean reduction of 4.3, from 5.8 at baseline to 1.5 at week 26.
Impact on Inflammation and Recurrence
In addition to pain reduction, the study assessed the impact of CardiolRx on inflammation. At week 8, CRP levels normalized (≤0.5 mg/dL) in 80% of patients with elevated baseline CRP (≥1 mg/dL), with a substantial mean reduction of 5.4 mg/dL observed (5.7mg/dL to 0.3 mg/dL). Overall, CRP levels for the entire patient group decreased from 2.0 mg/dL at baseline to 0.74 and 0.55 at weeks 8 and 26, respectively, with a median time to CRP normalization of 21 days.
Freedom from recurrence was maintained in 71% of patients during the extension period when CardiolRx was continued, and baseline medications were weaned off. For those experiencing a recurrence, the median time to an episode was 7.7 weeks during the extension period. The number of pericarditis episodes per year was markedly reduced from 5.8 prior to the study to 0.9 during the study.
Safety and Tolerability
CardiolRx demonstrated a strong safety profile, with 89% of patients progressing to the extension period and an overall study drug compliance rate of 95%. These results suggest that CardiolRx is both safe and well-tolerated in patients with recurrent pericarditis.
Implications for Future Development
"The compelling results from MAvERIC-Pilot showed that CardiolRx resulted in marked and rapid reductions in pericarditis pain and inflammation in patients with a high degree of disease burden as well as a striking decrease in pericarditis episodes per year," said David Elsley, President and CEO of Cardiol Therapeutics. "These results further support advancing our late-stage MAVERIC clinical development program comprising our recently announced Phase II/III MAVERIC-2 trial as well as our planned MAVERIC-3 Phase III trial."
The MAVERIC-3 trial is designed to assess CardiolRx for preventing recurrence in a broader population of pericarditis patients and is expected to run in parallel with the MAVERIC-2 Phase II/III trial, which evaluates CardiolRx in recurrent pericarditis patients following cessation of interleukin-1 blocker therapy.
About the MAvERIC-Pilot Study
To be eligible for enrollment, adult patients (≥18 years) were required to present with at least their third pericarditis episode, including symptomatic pericarditis chest pain with a numerical rating scale (NRS) pain score ≥4, together with either an elevated level of CRP ≥1 mg/dL or evidence of pericardial inflammation assessed by cardiac imaging. At baseline, patients were permitted to be receiving stable doses of concomitant medications for recurrent pericarditis.
Pericarditis: An Overview
Pericarditis involves inflammation of the pericardium, often resulting from a viral infection. Symptoms include chest pain, shortness of breath, and fatigue, leading to physical limitations and reduced quality of life. The only FDA-approved therapy for recurrent pericarditis is costly and typically used as a third-line intervention. Approximately 38,000 patients in the United States experience at least one recurrence annually, with a significant portion suffering for longer than two years. Hospitalization due to recurrent pericarditis can cost between $20,000 and $30,000 per stay.
