Cardiol Therapeutics Inc. (CRDL:TSX; CRDL:NASDAQ) is moving forward with a Phase III clinical trial (MAVERIC-3) for its drug CardiolRx, aimed at treating recurrent pericarditis. This decision follows the presentation of positive results from the Phase II MAvERIC-Pilot study at the American Heart Association Scientific Sessions 2024, which demonstrated marked improvements in pericarditis pain and inflammation among patients treated with CardiolRx.
The MAvERIC-Pilot study, which enrolled 27 participants, revealed that the benefits observed at the eight-week primary endpoint were sustained throughout the 26-week extension period. Patients in the study had an average age of 53 years, with 67% being female. Before entering the trial, participants experienced an average disease duration of 2.7 years and 5.8 pericarditis episodes per year.
Sustained Efficacy and Safety
Dr. S. Allen Luis, co-director of the Pericardial Diseases Clinic at the Mayo Clinic, highlighted the clinical relevance of the findings. "The data reported today show that patients enrolled in MAvERIC-Pilot, despite the severity of their disease, experienced clinically relevant and rapid reductions in both their pericarditis pain and C-reactive protein levels that were maintained throughout the study," said Luis. He also noted a substantial reduction in pericarditis episodes per year compared to the patients' historical event rate prior to the study, emphasizing the treatment's safety and tolerability in a population with significant disease burden.
Analyst Endorsements
Following the release of the Phase II results, Leede Financial Inc. analyst Dr. Douglas Loe maintained a Speculative Buy rating on Cardiol with a target price of CA$11.00. Loe emphasized the sustained efficacy of CardiolRx, noting that patients exhibited sustained pain relief, with average pain scores declining from 5.8 at enrollment to 1.5 at the six-month analysis. The analyst also pointed out that MAvERIC eight-week NRS data compares favorably to rilonacept's NRS data at the equivalent timepoint in the RHAPSODY trial.
Parallel Phase II/III Trial
Cardiol Therapeutics is also planning to initiate the MAvERIC-2 phase II/III trial, which will evaluate the impact of CardiolRx in recurrent pericarditis patients following cessation of interleukin-1 blocker therapy. This trial is expected to run in parallel with the MAVERIC-3 phase III trial.
Market Opportunity
The global market for cardiovascular drugs is projected to grow from US$149.99 billion in 2024 to US$207.78 billion by 2033, representing a CAGR of 4%, according to Precedence Research. This growth is driven by the increasing prevalence of heart-related conditions, including pericarditis, arrhythmias, coronary artery disease, hypertension, and heart failure.
