Cardiol Therapeutics to Advance CardiolRx(TM) into a Late-Stage Trial in Patients with Recurrent Pericarditis

Core Viewpoint - Cardiol Therapeutics is advancing its lead drug candidate CardiolRx™ into a late-stage clinical trial (MAVERIC-2) to evaluate its efficacy in patients with recurrent pericarditis after stopping interleukin-1 blocker therapy, aiming for accelerated regulatory approval [1][2][3] Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease, with its lead drug candidate being CardiolRx™, an oral solution of cannabidiol [7][8] Clinical Development - The MAVERIC-2 trial will be a randomized, double-blind, placebo-controlled Phase II/III study involving approximately 110 patients, assessing the impact of CardiolRx™ on freedom from recurrent pericarditis episodes after IL-1 blocker cessation [3][4] - The trial is expected to start in Q4 2024 at major pericardial disease centers in the U.S. and Europe, with results anticipated before the pivotal Phase III study (MAVERIC-3) [2][3] Scientific Rationale - IL-1 is a key pro-inflammatory cytokine in recurrent pericarditis, and current IL-1 blockers are costly and associated with immunosuppressive risks, leading to high recurrence rates of up to 75% after treatment cessation [4][5] - CardiolRx™ has shown potential in inhibiting the NLRP3 inflammasome and reducing pericarditis pain, offering a non-immunosuppressive alternative for patients intolerant to existing therapies [5][6] Previous Study Results - The MAvERIC-Pilot study demonstrated significant efficacy, with 80% of patients normalizing inflammation (CRP levels) and a substantial reduction in pericarditis pain reported at the end of the 8-week treatment period [5][6] - Full clinical data from the MAvERIC-Pilot study will be presented at the American Heart Association Scientific Sessions 2024, including outcomes related to recurrence and safety [5][6] Market Context - The only FDA-approved therapy for recurrent pericarditis is costly and primarily used as a third-line intervention, with an estimated 38,000 patients in the U.S. experiencing at least one recurrence annually [6][8] - Hospitalization costs for recurrent pericarditis range from $20,000 to $30,000 per stay, highlighting the need for more accessible treatment options [6][8]