Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) has reached a significant milestone in its mission to combat heart disease.
The company has wrapped up patient enrollment for its Phase II open-label pilot study, known as MAvERIC-Pilot, which focuses on patients suffering from recurrent pericarditis.
This condition involves inflammation of the pericardium, the membrane surrounding the heart, often following an initial viral infection.
The study aims to assess the safety, tolerability, and efficacy of CardiolRx, the company's flagship anti-inflammatory therapy.
Scheduled to release its topline results in the second quarter of 2024, Cardiol hopes this data will guide the design of a pivotal Phase III trial necessary for potential regulatory approval.
Recurrent pericarditis exacts a heavy toll on patients, causing severe chest pain, shortness of breath, and fatigue, leading to reduced quality of life and frequent hospital visits.
An estimated 38,000 individuals are affected in the United States annually, with significant associated healthcare costs.
CardiolRx has already received Orphan Drug Designation from the FDA.
Recruitment for the MAvERIC-Pilot study, which targeted 25 patients in the United States, has now concluded.
Patients enrolled in the study will undergo evaluations to measure improvements in objective disease markers, including pericarditis pain using a numeric rating scale.
Secondary endpoints include assessing freedom from pericarditis recurrence and changes in inflammatory markers like C-reactive protein.
The results are anticipated to shape the framework for a crucial Phase III clinical trial in recurrent pericarditis, aiming to support the potential regulatory approval of CardiolRx, Cardiol’s chief medical officer Andrew Hamer told investors.
"We thank our clinical collaborators and participating patients and families for their continued interest and commitment,” Hamer said in a statement.
“Their support is contributing to our understanding of the therapeutic profile of CardiolRx in this debilitating inflammatory heart disease associated with symptoms that adversely affect quality of life and physical activity."