- The U.S. Food and Drug Administration has given Cardiol Therapeutics (CRDL) clearance to proceed with its application to commence a phase two trial for CardiolRx
- The trial is designed to study the safety and tolerability of CardiolRx
- Cardiol plans to enroll 100 patients in its acute myocarditis study at clinical centers in the United States and Europe
- Cardiol Therapeutics is a clinical-stage biotechnology company
- Cardiol Therapeutics (CRDL) is up 2.89 per cent, trading at $3.92 per share
The U.S. FDA has given Cardiol Therapeutics (CRDL) clearance to proceed with its application to commence a phase two trial for CardiolRx.
The clearance allows Cardiol to move forward with its Investigational New Drug (IND) application for the trial.
The proposed multi-center, double-blind, randomized, placebo-controlled trial is designed to study the safety and tolerability of CardiolRx, as well as its impact on myocardial recovery in patients with acute myocarditis.
Myocarditis is an acute inflammatory condition of the myocardium, characterized by inflammation of the heart muscle.
Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is the most common cause of sudden cardiac death in people less than 35 years old.
Cardiol plans to enroll 100 patients in its acute myocarditis study at clinical centers in the United States and Europe.
David Elsley, president and CEO of Cardiol Therapeutics, commented on the study.
“IND clearance to proceed with our Phase II clinical trial of CardiolRx in patients with acute myocarditis represents another major milestone for Cardiol,” he said.
“We look forward to further studying the cardioprotective potential of CardiolRx,” he added, “in this rare but potentially devastating condition that remains an underdiagnosed cause of acute heart failure, sudden death, and chronic dilated cardiomyopathy.”
Cardiol believes there is an opportunity to develop its CardiolRx formulation as an orphan drug for the treatment of acute myocarditis, for which there is currently no accepted standard of care.
Cardiol Therapeutics is a clinical-stage biotechnology company focused on the research and clinical development of innovative anti-inflammatory therapies for the treatment of cardiovascular disease.
Cardiol Therapeutics (CRDL) is up 2.89 per cent, trading at $3.92 per share as of 12:49 pm ET.