Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) announced encouraging results from its Phase II MAvERIC-Pilot study, showcasing the sustained efficacy of its anti-inflammatory therapy, CardiolRx, in treating symptomatic recurrent pericarditis.
The findings, which were presented at the American Heart Association Scientific Sessions 2024, highlighted marked improvements in pericarditis pain and inflammation, with benefits persisting throughout the 26-week trial.
These results bolster the planned Phase III MAVERIC-3 trial, aimed at evaluating CardiolRx in preventing pericarditis recurrence, alongside the recently launched Phase II/III MAVERIC-2 trial.
The MAvERIC-Pilot study enrolled 27 patients with an average age of 53 and a history of 5.8 pericarditis episodes annually over 2.7 years. At baseline, the average pain score was 5.8 out of 10, and the mean C-reactive protein (CRP) level-a key inflammation marker-was 2.0 mg/dL.
Key findings from the study showed a mean pain score reduction of 3.7 points at the primary eight-week endpoint, with further improvement to 1.5 points by week 26.
C-reactive protein (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 dropped significantly, from 5.8 prior to the trial to 0.9 during the study.
Researchers also observed rapid pain resolution within just five days of initiating CardiolRx.
Additionally, 71% of participants remained free from recurrence during the extension period after tapering off standard therapies.
The results demonstrate substantial and clinically relevant reductions in pericarditis pain and inflammation, according to Dr. S. Allen Luis of the Mayo Clinic, who presented the findings.
The data underscore CardiolRx’s potential as a non-immunosuppressive therapy for tens of thousands of pericarditis patients, according to Cardiol's CEO, David Elsley.
"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,” David Elsley, CEO of Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) told investors.
“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.”
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.