Cardiol Therapeutics to Present Results from Phase 2 Recurrent Pericarditis Study

2 min read | September 10, 2024 01:53 PM EDT | By Team Kalkine Media

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Cardiol Therapeutics to Present Results from Phase 2 Recurrent Pericarditis Study — Image source: Shutterstock

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Cardiol Therapeutics (TSX:CRDL) has completed its Phase 2 MAvERIC-Pilot study evaluating the effects of its novel therapy, CardiolRx, on patients with recurrent pericarditis. The company plans to present the comprehensive results at the American Heart Association Scientific Sessions 2024, scheduled for November 18, 2024, at 9:45 a.m.

Dr. S. Allen Luis, co-director of the Pericardial Diseases Clinic at the Mayo Clinic, will deliver the presentation on behalf of the study team. The MAvERIC-Pilot study involved 27 adults with recurrent pericarditis a condition marked by repeated inflammation of the pericardium, the heart's protective sac across eight US locations. This study included an initial 8-week treatment phase followed by an 18-week extension period.

Patients enrolled in the study experienced pericarditis-related chest pain with a numerical rating score of 4 or higher, alongside elevated levels of C-reactive protein (CRP) or pericardial inflammation. CardiolRx was administered in addition to their existing treatments, which included non-steroidal anti-inflammatory drugs, colchicine, and/or corticosteroids.

The primary aim of the study was to evaluate the reduction in pericarditis pain after 8 weeks of treatment. Secondary objectives included assessing pain levels at 26 weeks, monitoring pericarditis recurrence during the extension period, CRP normalization, and the time required for CRP normalization in cases with elevated levels.

Cardiol Therapeutics' CEO, David Elsley, expressed enthusiasm about the forthcoming presentation of the positive primary endpoint results, which indicated significant reductions in both pericarditis pain and inflammation at the 8-week mark. This data will be featured prominently at one of the key sessions of the American Heart Association Scientific Sessions 2024.

Chief Medical Officer Andrew Hamer highlighted that the study's results will include additional endpoints, such as the freedom from pericarditis recurrence during the extension period, pain scores at 26 weeks, inflammatory marker levels, and evaluations of safety and tolerability. The company anticipates that these findings will further support the progression to a Phase 3 trial of CardiolRx, aiming to address this chronic inflammatory condition and its impact on patients' quality of life, mental health, and physical activity.

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