Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) Inc. has announced that the US Food and Drug Administration approved its Investigational New Drug (IND) application for a Phase II trial to study the safety and tolerability of CardiolRx as well as its impact on recovery in patients with acute myocarditis.
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.
Although the symptoms are often mild, the company said myocarditis remains an important cause of acute and fulminant heart failure and is the most common cause of sudden cardiac death in people younger than 35 years old. In addition, some patients proceed to develop chronic dilated cardiomyopathy, which continues to be the leading indication for cardiac transplantation.
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Myocarditis also can result from a broad range of infections and can be caused by certain drugs, including chemo-therapeutic agents used to treat several common cancers. Myocarditis also has been reported as a rare complication associated with certain vaccines for COVID-19.
Cardiol said its multi-center, double-blind, randomized, placebo-controlled study is expected to enroll 100 patients at clinical centers in the US and Europe.
The company said the primary endpoints of the trial, which will be evaluated after 12 weeks of therapy, consist of the following cardiac magnetic resonance measures: left ventricular function (ejection fraction and longitudinal strain) and myocardial edema (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis.
The study has been designed by an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence, including the Cleveland Clinic and the Mayo Clinic, among others.
"IND clearance to proceed with our Phase II clinical trial of CardiolRx in patients with acute myocarditis represents another major milestone for Cardiol as we continue to pursue the development of new treatment options for patients with inflammatory heart disease," said CEO David Elsley in a statement.
"We look forward to further studying the cardioprotective potential of CardiolRx in this rare but potentially devastating condition that remains an underdiagnosed cause of acute heart failure, sudden death, and chronic dilated cardiomyopathy."
No treatment exists for acute myocarditis
Given the risk of significant heart failure associated with acute myocarditis, the current intervention includes drugs commonly administered for heart failure. However, no generally accepted treatment exists for acute myocarditis. Some patients respond to immunosuppressive therapy in combination with steroids, or immune-modulation therapy using immune globulin.
Based on the large body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, Cardiol said it believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would be eligible for designation as an orphan drug.
The company noted that the program was successfully utilized to support the first FDA approval of cannabidiol for the treatment of rare pediatric epilepsy syndromes.
Cardiol added that it believes there is a similar opportunity to develop its CardiolRx formulation as an orphan drug.
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