Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has announced positive clinical results from its Phase II open-label MAvERIC-Pilot study, evaluating CardiolRx™ in patients with symptomatic recurrent pericarditis. The study's findings, presented at the American Heart Association Scientific Sessions 2024, reveal that the improvements in pericarditis pain and inflammation, initially reported at the 8-week primary endpoint, were maintained throughout the 26-week extension period.
Sustained Relief and Reduced Episodes
The MAvERIC-Pilot study enrolled 27 participants with an average age of 53 years, 67% of whom were female. The participants had an average disease duration of 2.7 years and experienced 5.8 pericarditis episodes per year before entering the trial. Baseline pericarditis pain score averaged 5.8 out of 10, and the C-reactive protein (CRP) level averaged 2.0 mg/dL. The study consisted of an 8-week treatment period followed by an 18-week extension period. During the initial 10 days, CardiolRx™ was added to baseline medications and up-titrated to 10 mg/kg twice daily, or the maximum tolerated dose. Patients were then weaned off baseline medications during the extension period to assess pericarditis recurrence while on CardiolRx™ monotherapy.
Key Findings
- The primary endpoint showed a mean reduction of 3.7 in patient-reported pericardial pain on an 11-point numerical rating scale, decreasing from 5.8 at baseline to 2.1 at week 8.
- The median time to resolution or near resolution of pain (score ≤ 2) was rapid, observed just 5 days after initiating CardiolRx™ treatment.
- 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.
- At week 8, 93% of patients reported a pain score reduction.
- CRP normalized (≤0.5 mg/dL) at week 8 in 80% of patients with a baseline CRP ≥1 mg/dL, with a substantial mean reduction of 5.4 mg/dL (5.7mg/dL to 0.3 mg/dL).
- CRP levels for the entire group of patients were reduced 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 patients were weaned off baseline medications. 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.
- CardiolRx™ was safe and well-tolerated, with 89% of patients progressing to the extension period and overall study drug compliance reported at 95%.
Expert Commentary
Dr. S. Allen Luis, Co-Director of the Pericardial Diseases Clinic at the Mayo Clinic, emphasized the clinical relevance of the findings, noting the rapid reductions in both pericarditis pain and C-reactive protein levels. He also highlighted the substantial reduction in pericarditis episodes per year and the favorable safety profile of CardiolRx™ in this patient population.
Implications for Future Trials
These results support the initiation of a Phase III trial (MAVERIC-3), designed to assess CardiolRx™ for the treatment of pericarditis patients to prevent recurrence. The MAVERIC-3 trial is expected to run in parallel with the recently announced MAVERIC-2 Phase II/III trial designed to evaluate the impact of CardiolRx™ in recurrent pericarditis patients following cessation of interleukin-1 blocker therapy. David Elsley, President and CEO of Cardiol Therapeutics, stated that these results further support advancing the late-stage MAVERIC clinical development program, offering the potential for a more accessible and non-immunosuppressive therapeutic option for pericarditis patients.
