Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) announced plans to expand its MAVERIC clinical development program with the launch of MAVERIC-2, a late-stage trial aimed at evaluating its lead drug candidate, CardiolRx, in patients with recurrent pericarditis.
The trial is expected to begin in Q4 2024 at major pericardial disease centers in the US and Europe.
The MAVERIC-2 trial will investigate the potential of CardiolRx in patients who have discontinued interleukin-1 (IL-1) blocker therapy, a common third-line treatment for recurrent pericarditis.
The study is intended to pave the way for an accelerated regulatory approval process ahead of the company's planned pivotal Phase III study, MAVERIC-3.
"MAVERIC-2 provides an exciting opportunity to expand the market potential for CardiolRx through the execution of a cost-effective study and potentially provides a path for an accelerated regulatory approval timeline," said David Elsley, CEO of Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL).
"This important new study, designed in collaboration with an international panel of advisors comprised of experts in pericarditis, will also augment data from our planned Phase III MAVERIC-3 trial by exploring the potential for our lead oral drug candidate to assist the growing number of recurrent pericarditis patients who seek alternative options to chronic use of immunosuppressant biologics."
The randomized, double-blind, placebo-controlled Phase II/III trial will enroll approximately 110 patients. Its primary objective is to assess the effectiveness of CardiolRx in preventing new episodes of pericarditis following the cessation of IL-1 blocker therapy.
The study will also evaluate secondary endpoints such as time to recurrence, patient-reported chest pain, and levels of the inflammatory marker C-reactive protein (CRP).
Dr Andrew Hamer, Chief Medical Officer at Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL), highlighted the potential benefits of CardiolRx as a non-immunosuppressive alternative to IL-1 blockers, which are costly and carry risks associated with long-term use.
"CardiolRx has been shown experimentally to inhibit assembly and activation of the NLRP3 inflammasome and the subsequent generation of IL-1, and following oral administration has led to marked reductions in pericarditis pain in patients suffering from chronic pericardial disease," Hamer said.
Cardiol previously reported positive topline data from its MAvERIC-Pilot study, which showed a reduction in pericarditis pain and normalization of CRP in 80% of patients. Full results will be presented at the American Heart Association Scientific Sessions in November 2024.