Cardiol Therapeutics Inc. is set to advance its lead drug candidate, CardiolRx, to a Phase III trial following positive results from a Phase II open-label MAvERIC-Pilot study. The study investigated the impact of CardiolRx in patients with symptomatic recurrent pericarditis, revealing marked improvements in pain and inflammation that were sustained throughout the 26-week study period.
MAvERIC-Pilot Study Results
The MAvERIC-Pilot study enrolled 27 participants across eight clinical sites in the United States. Participants had an average disease duration of 2.7 years and experienced an average of 5.8 pericarditis episodes per year prior to the trial, with baseline pain scores averaging 5.8 out of 10 and C-reactive protein levels averaging 2.0 mg/dL.
The study consisted of an 8-week treatment period, where CardiolRx was added to baseline medications, followed by an 18-week extension period, during which baseline medications were weaned off to assess pericarditis recurrence while patients received only CardiolRx.
Key Findings
The primary endpoint of patient-reported pericardial pain showed a mean reduction of 3.7, decreasing from 5.8 to 2.1 at week 8, with 93% of participants reporting a reduction in pain. The median time to resolution or near resolution of pain was just five days. Pain reduction further improved to 1.5 at week 26, representing a mean reduction of 4.3 during the entire trial period.
C-reactive protein levels normalized at week 8 in 80% of patients with baseline levels exceeding 1 mg/dL, with a mean reduction of 5.4 mg/dL observed, dropping from 5.7 mg/dL to 0.3 mg/dL. Overall, C-reactive protein levels decreased from 2.0 mg/dL at baseline to 0.74 mg/dL at week 8 and 0.55 mg/dL at week 26.
Freedom from recurrence was maintained in 71% of participants during the extended period when CardiolRx was administered and baseline medications were withdrawn. The number of pericarditis episodes per year was reduced from 5.8 prior to the study to just 0.9 during the study, with those experiencing a recurrence showing a median time to an episode of 7.7 weeks.
Safety and Tolerability
CardiolRx demonstrated a strong safety profile, with 89% of patients progressing to the extended period and an overall study drug compliance rate of 95%.
Expert Commentary
Dr. S. Allen Luis, Co-Director of the Pericardial Diseases Clinic at the Mayo Clinic, presented the data at the American Heart Association Scientific Sessions 2024, stating, "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. In addition, results demonstrated a substantial reduction in pericarditis episodes per year as compared to the patients’ historical event rate prior to the study."
The Significance of CardiolRx
Recurrent pericarditis affects an estimated 38,000 patients in the United States annually, leading to frequent emergency department visits and hospitalizations, costing between $20,000 and $30,000 per visit. Current treatment options are limited, with only one approved drug that is primarily used as a third-line intervention. CardiolRx offers the potential for a more accessible, non-immunosuppressive oral medication.
Future Trials
Cardiol Therapeutics plans to initiate the MAVERIC-3 Phase III trial to assess CardiolRx for the prevention of recurrence in pericarditis patients. This trial will run concurrently with the MAVERIC-2 Phase II/III trial, which is evaluating CardiolRx in recurrent pericarditis patients following cessation of interleukin-1 blocker therapy.
David Elsley, CEO of Cardiol Therapeutics, commented, "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. Undertaking both trials in parallel provides the exciting opportunity for CardiolRx to address the unmet needs of patients in multiple segments that encompass a broad proportion of the pericarditis population."
