Cardiol Therapeutics Inc (TSE:CRDL) (OTCQX:CRTPF) announced on Wednesday that the company has initiated its Health Canada approved Phase 1 clinical study of its lead drug CardiolRx, an extra strength formulation of pharmaceutical cannabidiol.
The Oakville, Ontario-based company produces cannabidiol products, such as its lead drug CardiolRx, for the treatment of cardiovascular diseases, including heart failure and acute myocarditis. According to the company, CardiolRx is an “extra strength formulation” of pharmaceutical cannabidiol that has been formulated to set the highest industry standard for “purity, consistency, and stability.”
The company’s Phase 1 clinical trial is a double-blind, placebo-controlled, randomized study to assess safety, tolerability, and pharmacokinetics of single followed by multiple day ascending doses of CardiolRx administered orally in up to 55 healthy adult subjects, both in the fasting and fed states.
The study is expected to be completed in the fourth quarter and is the first Health Canada approved study of a high concentration (100 mg/mL) cannabidiol formulation that contains virtually no THC (<5 ppm). This level of purity is key for patient populations who shouldn’t take THC, particularly children, where THC can impact brain development, and older patients who may be more susceptible to adverse drug effects, said the company.
By measuring standard safety parameters and the pharmacokinetics of CardiolRx, including the degree of drug absorption and resulting blood levels at escalating doses, the Phase 1 study will provide key information to optimize dosing levels for a planned Phase 2 international trial in acute myocarditis.
Cardiol's acute myocarditis trial has been designed by an independent steering committee made up of experts in heart failure and myocarditis from the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, University of Pittsburgh Medical Center, and Charité Hospital Berlin.
Acute myocarditis is an inflammatory heart condition that represents a leading cause of sudden cardiac death in children and otherwise healthy young adults. The common cause of acute myocarditis is a viral infection of the heart tissue which is initially responsible for the inflammation.
Based on the body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, the Canadian specialty pharmaceutical company believes there is an opportunity to develop “a potential breakthrough therapy” for acute myocarditis that could be an orphan drug.
The US orphan drug program offers companies big incentives, including multi-year marketing exclusivity, to develop treatments for diseases that affect fewer than 200,000 people in America. The program accelerated the first FDA approved cannabidiol for the treatment of two pediatric epilepsy syndromes as orphan diseases.
Cardiol is eyeing a similar opportunity to fast track the development of CardiolRx as an orphan drug for treating acute myocarditis for which there is currently no accepted standard of care.
"There is now increasing evidence that the SARS-CoV-2 virus (responsible for COVID-19) is causing a disturbing number of new cases of myocarditis in young adults, perhaps most notably Red Sox pitcher Eduardo Rodriguez and several US college football players,” Cardiol Therapeutics CEO David Elsley said in a statement.
“As global awareness of the devastating consequences of acute myocarditis increases in the wake of the COVID-19 pandemic, we see an opportunity to accelerate the development of CardiolRx as an important new cardioprotective therapy," he added.
Contact the author Uttara Choudhury at email@example.com
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