December 1, 2025 — Leads & Copy — Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has announced positive results from its Phase II ARCHER trial, which showed a significant reduction in left ventricular (LV) mass (p=0.0117) and improvements in key cardiac MRI (CMR) measures in patients with acute myocarditis.
The ARCHER trial data provides clinical evidence that CardiolRx™ reduces inflammation-driven structural damage in the heart, which is an important factor in heart failure progression. These findings strengthen the rationale for Cardiol’s Phase III program in recurrent pericarditis (MAVERIC) and support broader development across inflammatory cardiac conditions.
Dr. Andrew Hamer, Chief Medical Officer and Head of Research & Development of Cardiol Therapeutics, stated that the ARCHER results demonstrate that CardiolRx™ can drive meaningful structural recovery in the hearts of patients with acute myocarditis. He added that the beneficial cardiac changes observed in these patients are consistent with those previously seen in pre-clinical heart failure models, bolstering confidence in CardiolRx™ as a potential therapy for various inflammatory cardiac conditions.
Dr. Leslie T. Cooper, Jr., Chair of the Department of Cardiovascular Medicine at Mayo Clinic in Florida and Co-Chair of the Steering Committee for the ARCHER trial, presented the ARCHER data on November 29, 2025, at the Annual Meeting of the European Society of Cardiology Working Group on Myocardial & Pericardial Disease in Trieste, Italy. He noted that the positive changes in CMR measurements, particularly the reduction in LV mass, are exciting and consistent with numerical reductions in both extracellular volume (ECV) and intracellular volume (ICV).
Key findings from the ARCHER trial include:
A marked 9.2-gram reduction in left ventricular (LV) mass (p=0.0117).
Reductions in extracellular volume (ECV) and intercellular volume (ICV), indicating a meaningful structural improvement in the heart.
A reduction in left atrial end systolic volume (LAESV) in the active group compared to the placebo group, indicating improved heart relaxation and stress.
A reduction in left ventricular end diastolic volume (LVEDV) in the active group compared to the placebo group, reflecting improved ventricular function or reverse cardiac remodelling.
Dr. Dennis M. McNamara, Professor of Medicine at the University of Pittsburgh, Director of the Center for Heart Failure Research at the University of Pittsburgh Medical Center, and Chair of the ARCHER trial, noted that the study demonstrates improvements in key measures of cardiac structure and remodeling in patients with myocarditis, providing clinical proof of concept for advancing the clinical development of this novel therapeutic approach for inflammatory cardiac conditions, including heart failure.
David Elsley, President and Chief Executive Officer of Cardiol Therapeutics, stated that the ARCHER results strengthen the confidence in their broader pipeline and reinforce the growing recognition that cardiac inflammation is a treatable driver of disease progression.
Cardiol Therapeutics will host a webcast and conference call today at 8:30 a.m. EST to review the ARCHER trial results, discuss implications for future development, and outline next steps for their inflammatory heart disease programs. To participate by telephone, please dial 877-346-6112 (Canada and the United States) or +1-848-280-6350 (International). The conference call with also be broadcast live online through a listen-only webcast (with slides), which will be posted under “Events & Presentations” in the Investors section of the Cardiol website (cardiolrx.com/investors/events-presentations/) and archived for approximately 90 days.
CardiolRx™ was shown to be safe and well-tolerated in the ARCHER trial, with balanced treatment-emergent adverse events and serious adverse event rates between the active and placebo groups.
The ARCHER trial enrolled 109 patients from cardiovascular research centers in the United States, France, Brazil, and Israel. The design and rationale for ARCHER were published on June 27, 2024, in the journal, ESC Heart Failure.
Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on anti-inflammatory and anti-fibrotic therapies for heart disease. The Company’s lead small-molecule drug candidate, CardiolRx™, modulates inflammasome pathway activation. The MAVERIC Program is evaluating CardiolRx™ for the treatment of recurrent pericarditis, for which the U.S. FDA has granted Orphan Drug Designation. The Company is also developing CRD-38, a novel, subcutaneously administered drug formulation intended for the treatment of inflammatory heart disease, including heart failure.
Investor.relations@cardiolrx.com
Source: Cardiol Therapeutics Inc.
