- Cardiol Therapeutics (CRDL) has been approved by Health Canada to proceed with its Phase II trial of CardiolRx in Canada
- The Phase II acute myocarditis study is expected to enroll 100 patients at clinical centers in the United States, Canada, and Europe
- Health Canada’s approval follows the United States FDA’s clearance to proceed with an investigational new drug (IND) application
- Cardiol Therapeutics is a clinical stage biotechnology company focused on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease
- Shares in Cardiol Therapeutics Inc. (CRDL) are down 2.94 per cent, trading at $5.29 per share
Cardiol Therapeutics (CRDL) has been approved by Health Canada to proceed with its Phase II trial of CardiolRx in Canada.
Myocarditis is an acute inflammatory condition of the myocardium, characterized by inflammation of the heart muscle, which may result in chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances.
Given the risk of significant heart failure associated with acute myocarditis, current intervention includes drugs commonly administered for heart failure. However, no generally accepted treatment exists for acute myocarditis.
Cardiol believes it has the opportunity to develop its CardiolRx formulation as an orphan drug for the treatment of acute myocarditis.
The Phase II double-blind, randomized, placebo-controlled acute myocarditis study is expected to enroll 100 patients at clinical centers in the United States, Canada, and Europe.
Health Canada’s approval follows the United States FDA’s clearance to proceed with an investigational new drug (IND) application to commence this trial, which was announced in August.
Cardiol Therapeutics is a clinical-stage biotechnology company focused on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease.
Shares in Cardiol Therapeutics Inc. (CRDL) are down 2.94 per cent, trading at $5.29 per share as of 12:37 pm ET.