Welcome to our dedicated page for Cardiol Therapeutics news (Ticker: CRDL), a resource for investors and traders seeking the latest updates and insights on Cardiol Therapeutics stock.
Cardiol Therapeutics Inc. (NASDAQ: CRDL, TSX: CRDL) is a pioneering clinical-stage life sciences company specializing in the research and development of anti-inflammatory and anti-fibrotic therapies aimed at treating heart diseases. The company's primary focus is to address the unmet medical needs associated with heart failure, myocarditis, and pericarditis through its innovative drug formulations.
Cardiol is developing CardiolRx™, an oral cannabidiol formulation, which has shown promise in treating inflammatory conditions affecting the heart. The company has received Investigational New Drug Application (IND) authorization from the United States Food and Drug Administration (FDA) to conduct pivotal clinical trials evaluating the safety and efficacy of CardiolRx™ in heart diseases. The two key clinical studies are the ARCHER trial, a Phase II multi-national trial in acute myocarditis, and the MAvERIC-Pilot study, a Phase II open-label pilot study in recurrent pericarditis.
In recent developments, Cardiol has surpassed 50% patient enrollment in the MAvERIC-Pilot study, which aims to investigate the safety, tolerability, and efficacy of CardiolRx™ in patients with recurrent pericarditis. The study is designed to assess patient-reported pericarditis pain and other objective measures of the disease over an 8-week and 26-week period.
Notably, Cardiol has received Orphan Drug Designation (ODD) from the FDA for the treatment of pericarditis, including recurrent pericarditis, which offers benefits such as potential seven-year marketing exclusivity and tax credits for clinical trials. The ARCHER trial, which addresses acute myocarditis, has also made significant progress, surpassing 50% patient enrollment and expected to complete full enrollment during the third quarter of 2024.
Cardiol's commitment to advancing heart disease therapies is also evident in its development of CRD-38, a novel subcutaneously administered drug formulation of cannabidiol intended for use in heart failure. This innovative treatment approach aims to address a leading cause of death and hospitalization globally, with associated healthcare costs in the United States exceeding $30 billion annually. The company's initiatives are supported by extensive pre-clinical and clinical research, including collaborations with leading academic and medical institutions.
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
Cardiol Therapeutics presented its Phase II ARCHER trial at the World Congress on Acute Heart Failure 2024. The trial is evaluating CardiolRx™ in patients with acute myocarditis. The presentation included the trial design, rationale, and baseline data on the first 50 patients randomized.
The ARCHER trial has exceeded 85% of target enrollment, with a target of 100 patients across multiple countries. Its primary measures are cardiac MRI assessments of left ventricular function and myocardial edema/fibrosis. The MAvERIC-Pilot Phase II study for recurrent pericarditis is expected to report topline results in June 2024.
Acute myocarditis is a severe inflammatory condition with significant health risks. Cardiol's CEO highlighted the growing interest in myocarditis treatments and the contributions of clinical collaborators to the study's progress.
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