Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) has published the full results of its Phase II MAvERIC study of CardiolRx™ in recurrent pericarditis in the Journal of the American Heart Association, placing this peer-reviewed evidence behind its pivotal Phase III program on the record.
The open-label study enrolled 27 adults with symptomatic recurrent pericarditis at eight U.S. clinical sites. Participants averaged 5.8 pericarditis episodes per year prior to entry, a mean baseline pain score of 5.8 out of 10, and a history of at least three episodes.
In the trial, CardiolRx™, an oral formulation of pharmaceutically manufactured cannabidiol, was added to existing therapy for recurrent pericarditis over an eight-week treatment period and continued through an 18-week extension during which those background medications were weaned.
Pain, tracked on an 11-point numerical rating scale ranging from 0-10, fell by a mean of 3.7 points to 2.1 at week eight. The effect held through 26 weeks, with the measure falling by a mean of 4.3 over that time. C-reactive protein, the standard inflammation marker, declined from 2.0 mg/dL at baseline to 0.55 mg/dL by week 26. Recurrent pericarditis episodes per year dropped to 0.9 from 5.8. The drug was reported as safe and generally well tolerated.
This pilot study was open label (i.e., no placebo arm), however the data strengthens the foundation for the ongoing Phase III MAVERIC trial. MAVERIC is a pivotal, randomized, double-blind, placebo-controlled study is testing whether CardiolRx™ reduces the risk of recurrence, and enrollment is approaching completion after passing the 75% mark in May.
President and Chief Executive Officer David Elsley said the JAHA publication makes “the full body of peer-reviewed Phase II evidence available to the broader cardiovascular community,” adding that the findings directly shaped MAVERIC’s design.
The data was first presented at the American Heart Association Scientific Sessions, with the manuscript now just published. CardiolRx™ holds FDA Orphan Drug Designation for the treatment of pericarditis.
Cardiol Therapeutics Inc. (CRDL) last traded at $1.63 on the TSX.
