Cardiol Therapeutics Inc. announced that it will discontinue the LANCER trial due to lack of eligible patients to support recruitment and will prioritize its Phase II clinical programs focused on developing CardiolRx for two underserved diseases affecting the heart - acute myocarditis and recurrent pericarditis. The Company also announced that its cash runway now extends into 2026. The LANCER trial, which was designed to investigate the cardioprotective properties of CardiolRx in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease, will be discontinued due to the continuous decline in the number of eligible patients, and a lower than anticipated event rate in the study.

Over the course of the study, multiple factors contributed to the decline in the number of patients that met the inclusion criteria of the trial, including: (i) a significant increase in vaccine-induced or natural immunity in the general population; (ii) the predominant circulating variants causing milder disease than their predecessors; and (iii) an increase in the regulatory approval and usage of therapeutics for the successful treatment of mild-to-moderate disease in patients who previously would have progressed to require hospitalization. Cardiol is currently advancing its Phase II ARCHER trial, designed to assess CardiolRx in acute myocarditis, an inflammatory condition of the heart muscle (myocardium). ARCHER has received regulatory clearance in multiple jurisdictions, including Investigational New Drug Application (IND) authorization from the United States (U.S.) Food and Drug Administration (FDA), and is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel.

The trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence. The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance imaging measures: left ventricular function (ejection fraction and longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. Concurrent with the ARCHER trial, the Company is also undertaking a Phase II pilot study in recurrent pericarditis - a debilitating inflammatory heart disease.

Cardiol's study is expected to enroll 25 patients at major clinical centers specializing in pericarditis in the U.S. The study protocol has been designed in collaboration with thought leaders in pericardial disease. The study's primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.

Secondary endpoints include the pain score after 26 weeks of treatment, and changes in C-reactive protein (CRP).