Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) announced that it has completed its Phase 2 MAvERIC-Pilot study investigating the impact of its novel therapy CardiolRx in patients with recurrent pericarditis and it will be presenting the results at American Heart Association Scientific Sessions 2024.
The company said full clinical data from the trial will be reported during an oral presentation at the event on Monday, November 18, 2024, starting at 9:45am.
The data will be presented by Dr S. Allen Luis, co-director of the Pericardial Diseases Clinic at the Mayo Clinic, on behalf of the study investigators.
The MAvERIC-Pilot study investigated the effects of CardiolRx in 27 adults with recurrent pericarditis, a disease characterized by recurring episodes of inflammation of the pericardium, a sac-like organ surrounding the heart, at eight US sites.
It involved an 8-week treatment period and an 18-week extension period.
Patients with pericarditis-related chest pain (numerical rating score score ≥4) and elevated C-reactive protein (CRP) or pericardial inflammation were enrolled. CardiolRx was added to their existing treatments, which included non-steroid anti-inflammatory drugs, colchicine, and/or corticosteroids.
The primary goal of the study was to measure the change in pericarditis pain after 8 weeks. Secondary goals included pain score at 26 weeks, pericarditis recurrence during the extension period, CRP normalization, and time to CRP normalization for those with elevated CRP levels.
"Having recently reported the positive primary endpoint data from the MAvERIC-Pilot study demonstrating that oral administration of our small molecule CardiolRx led to marked reductions in pericarditis pain and inflammation at 8 weeks, we are delighted that the data has been accepted for oral presentation in such a prestigious session of the American Heart Association Scientific Sessions 2024, the premier global event for advancements in cardiovascular science and medicine," Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) CEO David Elsley commented.
"We extend our thanks and gratitude to the patients and our clinical research collaborators whose participation in this important study have served to support our objective of developing a more accessible and non-immunosuppressive therapeutic option for thousands of patients suffering from this chronic inflammatory heart disease."
Andrew Hamer, Cardiol Therapeutics’ chief medical officer, added that clinical results being presented from the study include additional endpoints, such as freedom from pericarditis recurrence during the 18-week extension period, 26-week pericarditis pain score and inflammatory marker levels, and safety and tolerability outcomes.
“We anticipate the totality of the results will support and further inform our plans to advance to a Phase 3 trial of CardiolRx in this inflammatory heart disease that is associated with symptoms that adversely affect quality of life, mental health, and physical activity,” Hamer said.