Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is set to begin a Phase 3 clinical trial, MAVERIC, for its lead oral drug, CardiolRx™, targeting patients with recurrent pericarditis who face a high risk of recurrence. This late-stage trial marks a significant step forward in addressing a condition with limited effective treatment options. Recurrent pericarditis is an inflammatory disease of the pericardium associated with debilitating chest pain, shortness of breath, and fatigue, leading to physical limitations, reduced quality of life, emergency department visits, and hospitalizations.
CardiolRx™: A Potential Game-Changer
CardiolRx™ is a pharmaceutically manufactured cannabidiol oral solution. It is distinguished by its ultra-high dose formulation, setting it apart from standard CBD products. Preclinical data suggests that cannabidiol inhibits activation of the inflammasome pathway, a key intracellular process in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
According to David Elsley, President and CEO of Cardiol Therapeutics, CardiolRx™ is uniquely positioned to address critical gaps in the current treatment options for recurrent pericarditis. The company aims to provide a safer, more cost-effective, and potentially disease-modifying therapy, significantly improving the standard of care for thousands of patients.
Clinical Evidence and Trial Design
Cardiol's Phase 2 trial results, presented at the American Heart Association, demonstrated sustained pain reduction and decreased inflammation markers in patients treated with CardiolRx™. These promising results paved the way for the advancement to a Phase 3 trial. The Phase 2/3 MAVERIC-2 trial and the planned Phase 3 MAVERIC-3 trial are designed to further evaluate the efficacy and safety of CardiolRx™ in patients with recurrent pericarditis.
The MAVERIC program builds upon the Phase II MAvERIC-Pilot study (NCT05494788). The FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, including recurrent pericarditis, which may expedite its development and regulatory pathway.
Addressing an Unmet Need
Recurrent pericarditis presents a significant clinical challenge, with limited treatment options currently available. The disease is characterized by recurring inflammation of the pericardium, leading to chest pain, shortness of breath, and fatigue. These symptoms can significantly impair a patient's quality of life and often result in frequent hospital visits.
Cardiol Therapeutics is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure. Heart failure remains a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
