Cardiol Therapeutics Reaches 50% Enrollment in Phase III MAVERIC Trial for Recurrent Pericarditis
核心洞察
Cardiol Therapeutics has achieved 50% patient enrollment in its pivotal Phase III MAVERIC trial evaluating CardiolRx™ for recurrent pericarditis (搜索) prevention.
The trial is actively enrolling patients across more than 15 leading cardiovascular centers in the United States, with additional sites coming online in Europe and Canada.
Full enrollment of approximately 110 patients is expected by Q2 2026, with the primary endpoint being freedom from new episodes of recurrent pericarditis (搜索) after six months.
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has surpassed 50% patient enrollment in MAVERIC, its pivotal Phase III randomized, double-blind, placebo-controlled, multi-center international trial evaluating CardiolRx™ for the prevention of disease recurrence in patients with recurrent pericarditis (搜索). The milestone represents a key execution and risk-reduction inflection point for the company's lead registrational program.
Strong Investigator Interest Drives Enrollment Progress
More than 15 leading cardiovascular centers across the United States are now actively enrolling patients in the MAVERIC trial, with additional premier sites coming online in Europe and Canada. The enrollment momentum reflects both the high unmet medical need in recurrent pericarditis (搜索) and investigator confidence in the trial's scientific rationale and design.
"Surpassing 50% enrollment in MAVERIC is an important milestone for our Phase III program and reflects both the high unmet medical need in recurrent pericarditis (搜索) and the confidence investigators have in the scientific rationale and rigorous design of this pivotal trial," said Dr. Andrew Hamer, Chief Medical Officer and Head of Research & Development at Cardiol Therapeutics.
Trial Design and Endpoints
MAVERIC is expected to enroll approximately 110 patients across some 25 leading cardiovascular research centers in the United States, Canada, and Europe. The trial was designed in collaboration with an international steering committee of independent pericarditis (搜索) experts. Full enrollment is expected in Q2 2026.
The primary endpoint, assessed after six months of double-blind treatment, is freedom from a new episode of recurrent pericarditis (搜索). Secondary efficacy endpoints include the percentage of days with no or minimal pericarditis (搜索) pain, changes in pericarditis pain scores, and changes in the inflammatory biomarker C-reactive protein (搜索) (CRP).
Phase II Results Support Advancement
The Phase III trial builds on positive results from Cardiol's Phase II MAvERIC-Pilot study. In that study, patients treated with CardiolRx™—despite a high baseline disease burden—experienced rapid and sustained reductions in pericarditis (搜索) pain and inflammation, along with a marked reduction in recurrence events per year. CardiolRx™ was shown to be safe and well tolerated, providing the scientific and clinical rationale for advancement into the pivotal Phase III trial.
Positioning for Broader Patient Access
David Elsley, President and Chief Executive Officer, emphasized the potential for CardiolRx™ to serve as a more accessible treatment option. "The continued expansion of the MAVERIC program underlines the importance of evaluating additional treatment options for use earlier in the recurrent pericarditis (搜索) treatment paradigm—before patients are exposed to prolonged corticosteroid use or immunosuppressive biologics such as interleukin-1 inhibitors," Elsley said.
The company believes CardiolRx™'s oral, non-immunosuppressive profile positions it as a more accessible therapeutic option for a substantially broader patient population than is currently served by biologic therapies, which are forecast to generate over $800 million in U.S. revenues in 2026.
About Recurrent Pericarditis and CardiolRx™
Recurrent pericarditis (搜索) is an inflammatory disease of the pericardium associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, which can lead to physical limitations, reduced quality of life, emergency department visits, and hospitalizations.
CardiolRx™ is Cardiol's lead small-molecule drug candidate that modulates inflammasome pathway (搜索) activation, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with pericarditis (搜索), myocarditis (搜索), and heart failure (搜索). The U.S. FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, including recurrent pericarditis (搜索).
Broader Development Pipeline
Beyond the MAVERIC program, Cardiol is also developing CardiolRx™ through the ARCHER Program for acute myocarditis (搜索)—an important cause of acute and fulminant heart failure (搜索) in young adults and a leading cause of sudden cardiac death in individuals under 35 years of age. The company has completed the Phase II ARCHER study, which evaluated the safety, tolerability, and efficacy of CardiolRx™ in this patient population.
Additionally, the company is developing CRD-38, a novel, subcutaneously administered drug formulation intended for the treatment of inflammatory heart disease (搜索), including heart failure (搜索)—a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding US$30 billion per year.