CBD-Based Drug Reduces Pericarditis Pain And Inflammation, Shows New Clinical Study

Cardiol Therapeutics Inc. CRDL, a clinical-stage life sciences company, reported results from its Phase II open-label MAvERIC-Pilot study of CardiolRx, a cannabidiol-based therapy for treating symptomatic recurrent pericarditis. Cannabidiol (CBD) is a non-psychoactive compound found in the cannabis plant.

The study, presented at the American Heart Association Scientific Sessions 2024, showed sustained reductions in pericarditis pain and inflammation over 26 weeks.

“The data reported today show that patients enrolled in MAvERIC-Pilot, despite the severity of their disease, experienced clinically relevant and rapid reductions in both their pericarditis pain and C-reactive protein levels that were maintained throughout the study," stated Dr. S. Allen Luis, co-director of the Pericardial Diseases Clinic and associate professor of Medicine in the Department of Cardiovascular Medicine at the Mayo Clinic. "In addition, results demonstrated a substantial reduction in pericarditis episodes per year as compared to the patients’ historical event rate prior to the study. Importantly, treatment was shown to be safe and well tolerated in a population who presented with significant disease burden. I look forward to further investigation in the upcoming Phase II/III and Phase III clinical trials.”

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Study Key Takeaways

The trial enrolled 27 participants (67% female, average age 53) at eight U.S. clinical sites. Patients, with a baseline history of 5.8 episodes per year and significant disease burden, received CardiolRx in addition to existing therapies before transitioning to monotherapy during the study's extension period.

• Pericardial pain was reduced from 5.8 at baseline to 1.5 at week 26.
• Just five days following initiation of CardiolRx, near resolution of pain was observed.
• Improvements in inflammation were noted with C-reactive protein (CRP) levels normalizing in 80% of patients by week eight, with sustained improvements throughout the study
• At week 8, 93% (25/27) of patients reported a pain score reduction.
• CardiolRx was well tolerated, with no significant adverse events reported and a 95% compliance rate.

“The compelling results from MAvERIC-Pilot showed that CardiolRx resulted in marked and rapid reductions in pericarditis pain and inflammation in patients with a high degree of disease burden as well as a striking decrease in pericarditis episodes per year," stated David Elsley, president and CEO of Cardiol Therapeutics. "The notable impact of CardiolRx on these important clinical endpoints demonstrates its potential to offer a more accessible and non-immunosuppressive therapeutic option for tens of thousands of pericarditis patients.”

Elsley added that these results support advancing the MAVERIC program, which includes the upcoming Phase II/III MAVERIC-1 and Phase III MAVERIC-3 trials.

Cardiol focuses on developing anti-inflammatory and anti-fibrotic therapies for heart diseases. Its lead drug, CardiolRx, leverages cannabidiol's ability to inhibit inflammasome pathways, with applications in pericarditis, myocarditis, and heart failure. The company holds Investigational New Drug Application authorization from the United States Food and Drug Administration to conduct clinical studies to evaluate the efficacy and safety of CardiolRx in two diseases affecting the heart: recurrent pericarditis and acute myocarditis.

Price Action

Cardiol Therapeutics shares closed Monday's market session 1.65% lower at $1.79 per share.

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