Cardiol Therapeutics Inc (TSX: CRDL, NASDAQ: CRDL) said it would 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 trail now extends until 2026.
The company also said it would discontinue its LANCER trial, which was designed to study the cardioprotective properties of CardiolRx in patients hospitalized with COVID-19 who have a history or risk factors for cardiovascular disease, due to a continued decline in the number of eligible patients and a lower event rate than expected in the study.
In a statement, David Elsley, Cardiol Therapeutics (TSX: CRDL, NASDAQ: CRDL)‘ commented, “The decision to end the LANCER trial was difficult but necessary, as the course of the disease and its management have inhibited our ability to recruit eligible patients to such an extent that the continuation of the test is no longer practical.
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“We would like to express our thanks and gratitude to the many patients who agreed to participate in LANCER, as well as to acknowledge and thank the staff at our clinical trial site who participated and contributed their expertise and experience. , 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 drugs for the treatment of debilitating heart disease that affects all age groups. and remain underserved by available therapies,” he added.
Cardiol noted that during the LANCER study, several factors contributed to the decline in the number of patients meeting the trial’s inclusion criteria, including: (i) a significant increase in vaccine or natural in the general population; (ii) the predominant circulating variants causing milder disease than their predecessors; and (iii) increased regulatory approval and use of therapeutics for the successful treatment of mild to moderate disease in patients who previously would have required hospitalization.
Phase II ARCHER trial progress
The company said it is currently progressing its Phase II ARCHER trial, designed to evaluate 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) clearance from the U.S. Food and Drug Administration (FDA), and is expected to enroll 100 patients across major cardiac centers in North America, Europe, Latin America and Israel.
The trial was designed in collaboration with an independent steering committee made up of eminent opinion leaders in the field of heart failure and myocarditis from international centers of excellence. The primary endpoints of the trial, which will be assessed after 12 weeks of double-blind treatment, consist of the following cardiac magnetic resonance imaging measurements: left ventricular function (ejection fraction and longitudinal strain) and edema /myocardial fibrosis (extracellular volume), each of which has been shown to predict the long-term prognosis of patients with acute myocarditis.
Alongside the ARCHER trial, the company also announced that 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 from leading pericarditis clinical centers in the United States. The study protocol was designed in collaboration with opinion leaders in the field of pericardial disease.
The primary efficacy endpoint of the study is the change from baseline to 8 weeks in patient-reported pericarditis pain using a numerical rating scale (NRS) at 11 dots. The NRS is a validated clinical tool used in multiple acute and chronic pain conditions, including previous studies of recurrent pericarditis. Secondary endpoints include pain score after 26 weeks of treatment and changes in C-reactive protein (CRP), Cardiol added.
US Orphan Drug Designation Program
Cardiol said it plans to continue development of CardiolRx as an orphan drug for the treatment of acute myocarditis and recurrent pericarditis.
The U.S. Orphan Drug Designation Program was created to provide a drug sponsor with significant incentives, including seven-year market exclusivity and exemptions from certain FDA fees, to develop treatments for diseases that affect less than 200,000 people in the United States. Products with orphan drug designation are also often eligible for expedited regulatory review. The program was successfully used to support the first FDA approval of cannabidiol for the treatment of seizures associated with rare pediatric epileptic syndromes. The European Union has a similar program for rare diseases.
Cardiol Therapeutics (TSX: CRDL, NASDAQ: CRDL) is a clinical-stage life science company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company’s lead product candidate, CardiolRx, is a pharmaceutically-manufactured oral formulation of cannabidiol that is in clinical development for use in heart disease.
Cardiol is also developing a new drug formulation of cannabidiol administered subcutaneously 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 a year.
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