Cardiol Therapeutics Inc. disclosed that its Phase II ARCHER trial in patients with acute myocarditis produced a statistically significant 9.2‑gram reduction in left ventricular mass (p = 0.0117) and favorable changes in extracellular and interstitial volume, with no increase in adverse events leading to discontinuation.
The 9.2‑gram drop in left ventricular mass represents a measurable reversal of the structural remodeling that drives heart failure and sudden death in myocarditis. The accompanying reduction in extracellular volume, driven by a p‑value of 0.0538, signals a decrease in myocardial edema and fibrosis, suggesting that CardiolRx can halt or reverse the inflammatory cascade that underlies the disease.
These findings reinforce CardiolRx’s therapeutic promise across inflammatory cardiac indications and provide a strong rationale for the company’s pivotal Phase III MAVERIC trial in recurrent pericarditis, for which it holds FDA orphan drug designation. The data also support the broader pipeline, including CRD‑38, a next‑generation small molecule aimed at heart failure with preserved ejection fraction, by demonstrating that the company’s inflammasome‑targeting platform can translate into clinically meaningful cardiac remodeling.
To sustain its clinical program, Cardiol Therapeutics raised $11 million in a private placement, giving the company additional runway to advance CardiolRx and CRD‑38 through late‑stage development. Management emphasized that the infusion of capital will allow the company to maintain its focus on early‑phase safety and efficacy while preparing for the larger Phase III studies.
Dr. Andrew Hamer, Chief Medical Officer, said the ARCHER results “show that CardiolRx can drive meaningful structural recovery in the hearts of patients with acute myocarditis.” Dr. Leslie T. Cooper, Jr., co‑chair of the ARCHER steering committee, added that the data “provide a sound rationale for advancing the clinical development of this novel therapy in conditions characterized by cardiac edema, fibrosis, and remodeling.” President and CEO David Elsley noted that the trial “fortifies our confidence in our broader pipeline and underscores the treatable nature of cardiac inflammation.”
While the announcement is a milestone for Cardiol Therapeutics, the company remains in the early‑stage development phase, and the results will be discussed in a webcast and conference call scheduled for 8:30 a.m. EST on the same day.
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