Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) released data from its Phase II MAvERIC-Pilot study demonstrating that its lead drug candidate CardiolRx significantly reduces pericarditis pain and inflammation, showing promise as a non-immunosuppressive treatment option.
The study, which assessed the efficacy of CardiolRx in treating symptomatic recurrent pericarditis, revealed a significant reduction in patient-reported pericarditis pain, the primary efficacy endpoint.
Additionally, 80% of patients with elevated C-reactive protein (CRP) levels at the study's onset saw normalization of this inflammation marker by the end of the treatment period.
Orally administrated CardiolRx achieved pain and inflammation reductions comparable to those seen with immunosuppressive biologics, typically used in advanced treatment stages, noted Cardiol CEO David Elsley.
This could pave the way for a Phase III trial aimed at offering a more accessible, non-immunosuppressive therapy for pericarditis patients.
"Based on the clinically meaningful impact of CardiolRx on the key symptom of this debilitating disease, we now anticipate that the totality of the MAvERIC-Pilot data will support advancing to a Phase III trial of CardiolRx designed to meet our objective of providing a more accessible and non-immunosuppressive therapy option for thousands of pericarditis patients,” Elsley told investors.
The MAvERIC-Pilot study included 27 patients, each with a significant disease burden and a history of multiple pericarditis episodes.
The primary endpoint showed a mean pain score reduction from 5.8 to 2.1 on an 11-point numerical rating scale.
Furthermore, eight out of ten patients with high baseline CRP levels achieved normalization, and overall CRP levels decreased from 5.7 mg/dL to 0.3 mg/dL.
Notably, 89% of participants continued into the study's 18-week extension period, with CardiolRx proving safe and generally well-tolerated.