Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) announced it has successfully enrolled over 50% of the targeted number of patients for its Phase II open-label pilot study on its lead candidate CardiolRx.
The primary objective of the MAvERIC-Pilot study is to assess the safety, tolerability, and efficacy of CardiolRx in patients with recurrent pericarditis, a rare and debilitating inflammatory heart disease known for reducing the quality of life and physical well-being of those affected.
The study aims to evaluate not only standard safety parameters but also objective measures of improvement in recurrent pericarditis and the feasibility of reducing background therapy, including corticosteroids while administering CardiolRx during an extension period.
David Elsley, CEO of Cardiol, told investors that the study’s findings will contribute to a better understanding of the therapeutic potential of CardiolRx in recurrent pericarditis, potentially informing the design of a pivotal Phase III clinical trial and regulatory approval of the drug.
"Achieving this milestone reflects the commitment and interest demonstrated by our clinical collaborators and participating patients, and we thank them for their contribution to the progress being made in this important study,” Elsley added.
MAvERIC-Pilot is currently enrolling 25 patients at specialized medical research centers in the United States that focus on pericarditis care. The study, led by Allan Klein, MD, Director of the Center of Pericardial Diseases and Professor of Medicine at the Cleveland Clinic, has defined primary and secondary efficacy endpoints, including changes in patient-reported pericarditis pain, NRS scores after 26 weeks, and alterations in circulating levels of C-reactive protein.
CardiolRx, the lead investigational drug, has already demonstrated its potential in pre-clinical research. Collaborators from Virginia Commonwealth University have shown its protective effects in a pericarditis model, reducing imaging signs of pericardial effusion and thickening and suppressing pro-inflammatory markers IL-1β and IL-6, which contribute to recurrent pericarditis symptoms.
Cardiol is a clinical-stage life sciences company, dedicated to developing anti-inflammatory and anti-fibrotic therapies for heart disease treatment.