Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) Inc announced it has received Health Canada approval to proceed with its Phase II trial of lead drug CardiolRx for acute myocarditis.
The multi-center, double-blind, randomized, and placebo-controlled trial will look at the safety and tolerability of CardiolRx as well as its impact on myocardial recovery in patients with the debilitating condition.
Phase II involves 100 patients at clinical centers in the US, Canada, and Europe.
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The approval from Health Canada comes after the US Food and Drug Administration (FDA) gave the firm clearance to go ahead with an Investigational New Drug (IND) application to start a Phase II trial, which Cardiol first announced in August 2021.
“Based on the large body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, the company 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 in the United States,” Cardiol said in a statement.
The US Orphan Drug Designation program was created to offer companies incentives to develop treatments for diseases that affect fewer than 200,000 people in the US, and helped to support the first FDA approval of cannabidiol for the treatment of rare child-onset epilepsy syndromes.
Cardiol told shareholders it believes there is a similar 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.
CardiolRx is formulated to be one of the safest and most consistent CBD medicines available on the market thanks to a proprietary formula of ultra-pure pharmaceutical cannabidiol (CBD) that does not contain THC - less than 10 parts per million (ppm) - and consequently none of the psychotropic effects of THC.
Oakville, Ontario-based Cardiol is a clinical-stage biotechnology company focused on the research and clinical development of innovative anti-inflammatory therapies for the treatment of cardiovascular disease.
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