Cardiol Therapeutics Inc (TSX:CRDL, NASDAQ:CRDL) has said it will prioritize its Phase II clinical programs focused on developing CardiolRx for two underserved diseases affecting the heart - acute myocarditis and recurrent pericarditis - and announced that its cash runway now extends into 2026.
The company also said it will discontinue its 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, due to a continuous decline in the number of eligible patients, and a lower than anticipated event rate in the study.
In a statement, David Elsley, Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL)' president and CEO commented: "The decision to terminate the LANCER trial was difficult but necessary, as the evolution of the disease and its management have inhibited our ability to recruit eligible patients to such an extent that continuing the trial is no longer practical."
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"We would like to extend our thanks and gratitude to the many patients who agreed to take part in LANCER, as well as acknowledge and thank our clinical trial site personnel who participated and contributed their expertise and experience. Notwithstanding this, we are in a strong financial position to support our international collaborations with world-class researchers and clinicians who are at the forefront of developing important medicines for the treatment of debilitating heart diseases that affect all age groups and remain underserved by available therapies," he added.
Cardiol noted that over the course of the LANCER 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.
Advancing Phase II ARCHER trial
The company said it 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 US 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 also said it is 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 US. 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), Cardiol added.
US Orphan Drug Designation Program
Cardiol said it is planning to pursue the development of CardiolRx as an Orphan Drug for the treatment of acute myocarditis and recurrent pericarditis.
The US Orphan Drug Designation program was created to provide the sponsor of a drug significant incentives, including seven-year marketing exclusivity and exemptions from certain FDA fees, to develop treatments for diseases that affect fewer than 200,000 people in the US Products with Orphan Drug Designation also frequently qualify for accelerated regulatory review. The program was successfully utilized to support the first FDA approval of cannabidiol for the treatment of seizures associated with rare pediatric epilepsy syndromes. The European Union has a similar program for rare diseases.
Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart diseases. The company's lead product candidate, CardiolRx, is a pharmaceutically manufactured oral cannabidiol formulation that is being clinically developed for use in heart diseases.
Cardiol is also developing a novel subcutaneously administered drug formulation of cannabidiol intended for use in heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
Contact the author at jon.hopkins@proactiveinvestors.com