02:16:24 EST Wed 14 Jan 2026
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Cardiol Therapeutics Inc
Symbol CRDL
Shares Issued 99,489,406
Close 2026-01-13 C$ 1.35
Market Cap C$ 134,310,698
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Cardiol eclipses 50% patient enrolment in Maveric trial

2026-01-13 17:18 ET - News Release

Mr. David Elsley reports

CARDIOL THERAPEUTICS ACHIEVES KEY 50% PATIENT ENROLLMENT MILESTONE IN PIVOTAL PHASE III MAVERIC TRIAL IN RECURRENT PERICARDITIS

Cardiol Therapeutics Inc. has surpassed 50-per-cent patient enrolment in Maveric, its phase III randomized, double-blind, placebo-controlled, multicentre international trial evaluating CardiolRx for the prevention of disease recurrence in patients with recurrent pericarditis.

  • Clinical trial infrastructure fully operational in the United States with more than 15 leading cardiovascular centres actively enrolling patients;
  • Activation of additional top-tier clinical sites in Europe and Canada under way, further accelerating enrolment momentum;
  • Full enrolment expected in Q2 2026.

Reaching this enrolment milestone represents a key execution and risk-reduction inflection point for Cardiol's lead registrational program and underscores strong investigator interest in advancing new treatment options for this underserved patient population.

"Surpassing 50-per-cent enrolment in Maveric is an important milestone for our phase III program and reflects both the high unmet medical need in recurrent pericarditis 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 and development at Cardiol Therapeutics. "More than 15 leading cardiovascular centres across the United States are now actively enrolling patients, and with additional premier sites coming on line in Europe and Canada, we are well positioned to sustain recruitment momentum, complete enrolment in Q2 2026 and deliver high-quality clinical data supporting CardiolRx as a differentiated oral therapy for this challenging disease."

"The continued expansion of the Maveric program underlines the importance of evaluating additional treatment options for use earlier in the recurrent pericarditis treatment paradigm -- before patients are exposed to prolonged corticosteroid use or immunosuppressive biologics such as interleukin-1 inhibitors," said David Elsley, president and chief executive officer. "Importantly, data from the recent Archer study demonstrating improvements in cardiac structure in patients with myocarditis reinforce our position that CardiolRx has the potential to meaningfully change the management of recurrent pericarditis. Taken together, these findings support our conviction that 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."

The Maveric phase III trial was designed in collaboration with an international steering committee of independent pericarditis experts and builds on the 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 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 this pivotal phase III trial.

Maveric is expected to enroll approximately 110 patients across some 25 leading cardiovascular research centres in the United States, Canada and Europe. The primary end point, assessed after six months of double-blind treatment, is freedom from a new episode of recurrent pericarditis. Secondary efficacy end points include the percentage of days with no or minimal pericarditis pain, changes in pericarditis pain scores, and changes in the inflammatory biomarker C-reactive protein (CRP).

About Cardiol Therapeutics Inc.

Cardiol Therapeutics is a late-stage life sciences company focused on advancing the development of anti-inflammatory and anti-fibrotic therapies for heart disease. The company's lead small-molecule drug candidate, CardiolRx, modulates inflammasome pathway activation, an intracellular process known to play an important role in the development and progression of inflammation, and fibrosis associated with pericarditis, myocarditis and heart failure.

The Maveric program is evaluating CardiolRx for the treatment of recurrent pericarditis, 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. The program comprises the completed phase II Maveric-Pilot study (NCT05494788) and the continuing pivotal phase III Maveric trial (NCT06708299). The U.S. Food and Drug Administration has granted orphan drug designation to CardiolRx for the treatment of pericarditis, including recurrent pericarditis.

The Archer program is also studying CardiolRx, specifically in acute myocarditis -- an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in individuals under 35 years of age. The program comprises the completed phase II Archer study (NCT05180240), which evaluated the safety, tolerability and efficacy of CardiolRx in this patient population.

The company is also developing CRD-38, a novel, subcutaneously administered drug formulation intended for the treatment of inflammatory heart disease, including heart failure -- a leading cause of death and hospitalization in the developed world, with associated health care costs in the United States exceeding $30-billion (U.S.) per year.

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