Cardiol Therapeutics Announces Database Lock for Phase II ARCHER Trial of CardiolRx(TM) in Acute Myocarditis

Core Viewpoint - Cardiol Therapeutics has announced the database lock for its Phase II ARCHER trial of CardiolRx™ in patients with acute myocarditis, marking a significant milestone in the study and paving the way for statistical analysis and topline results expected within two weeks [2][3]. Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease, with its lead asset being CardiolRx™, a cannabidiol oral solution [2][7]. - The company has received Investigational New Drug Application authorization from the US FDA to conduct clinical studies for CardiolRx™ in acute myocarditis and recurrent pericarditis [8]. Trial Details - The ARCHER trial is a Phase II multi-national, randomized, double-blind, placebo-controlled study investigating the safety and efficacy of CardiolRx™ on myocardial recovery in patients with acute myocarditis, enrolling over 100 patients from various countries [3][5]. - The primary outcome measures include cardiac magnetic resonance imaging parameters such as global longitudinal strain and extra-cellular volume, which are critical for assessing myocardial function and fibrosis [3][5]. Significance of Acute Myocarditis - Acute myocarditis is a serious cardiovascular condition with no FDA-approved pharmacological therapies, characterized by symptoms such as chest pain, shortness of breath, and fatigue, and can lead to severe complications including heart failure and sudden cardiac death [5][6]. - The condition is notably prevalent among younger populations, with viral infections being the most common cause [6]. Future Directions - Results from the ARCHER trial are anticipated to provide insights that will guide the broader development strategy for Cardiol Therapeutics, particularly in heart diseases where fibrosis is a significant factor [3][8]. - The company is also advancing its Phase III MAVERIC trial of CardiolRx™ in recurrent pericarditis, further emphasizing its commitment to addressing unmet medical needs in cardiovascular diseases [3][8].