Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) Inc. announced that the first patient has been enrolled in ARCHER, a Phase 2 trial designed to study the safety and tolerability of the oral cannabinoid formulation CardiolRx in patients with acute myocarditis.
CardiolRx is a pharmaceutically produced formulation being developed for the treatment of acute and chronic inflammation associated with heart disease. Myocarditis is an acute inflammatory condition of the heart muscle characterized by chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances. It is a leading cause of sudden cardiac death in people under 35 years of age.
The ARCHER study has received Investigational New Drug (IND) clearance from the Food and Drug Administration. The plan is to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel.
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The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, include left ventricular function (ejection fraction and longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), which are both predictive measures of long-term prognosis, the company said.
"We have long suspected that it is the response to injury that needs to be addressed to improve outcomes in myocarditis,” said Dennis McNamara, director of the Center for Heart Failure Research at the University of Pittsburgh Medical Center and chair of the study steering committee. “Given its impact limiting these inflammatory mechanisms, we believe cannabidiol has the potential to truly benefit patients with this condition.”
Cardiol noted that acute myocarditis should be managed with guideline-directed therapies for heart failure, arrhythmia and conduction disturbances. That said, there is no uniformly accepted treatment for the underlying inflammatory processes.
That’s where the company believes the opportunity exists to develop a new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the U.S. Orphan Drug Designation provides the sponsor of a drug developed to treat a disease that affects fewer than 200,000 people in the U.S. with seven-year marketing exclusivity and exemptions from certain FDA fees. For reference, 73,000 myocarditis cases are estimated in the U.S. annually.
The program was utilized to support the first FDA approval of cannabidiol for the treatment of seizures associated with rare pediatric epilepsy syndromes, which Cardiol believes indicates a similar opportunity for its CardiolRx formulation to earn orphan drug status for the treatment of acute myocarditis.
Oakville, Ontario-based Cardiol is a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-fibrotic and anti-inflammatory therapy for the treatment of cardiovascular disease.
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