| Oakville, ON – August 26, 2020
Cardiol Therapeutics Inc. (TSX: CRDL)(OTCQX: CRTPF) (“Cardiol” or the “Company”), a leader in the development of pharmaceutical cannabidiol formulations for the treatment of cardiovascular diseases, including heart failure and acute myocarditis, is pleased to announce the initiation of its Health Canada approved Phase 1 clinical study of CardiolRx™. CardiolRx is an extra strength formulation of pharmaceutical cannabidiol that has been formulated to set the highest industry standard for purity, consistency, and stability.
Cardiol’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 during Q4, 2020, and is believed to represent 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 extremely important for patient populations who should not take THC, particularly children, where THC can impact brain development, and older individuals who wish to avoid intoxication and who may be more susceptible to adverse drug effects.
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 important information to optimize dosing levels for the Company’s planned Phase 2 international trial in acute myocarditis. Cardiol’s acute myocarditis trial has been designed by an independent steering committee comprising highly distinguished thought leaders in heart failure and myocarditis from international centers of excellence, including: 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 Charit Hospital Berlin.
Acute myocarditis is an inflammatory condition of the heart that represents a leading cause of sudden cardiac death in children and otherwise healthy young adults. The most common cause of acute myocarditis is a viral infection of the heart tissue which is initially responsible for the inflammation. 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 an opportunity to develop a potential breakthrough therapy for acute myocarditis that would be eligible for designation as an orphan drug. The U.S. orphan drug program was created to offer companies significant incentives, including multi-year marketing exclusivity, to develop treatments for diseases that affect fewer than 200,000 people in the U.S. The program was successfully utilized to accelerate the first FDA approval of cannabidiol for the treatment of two pediatric epilepsy syndromes as orphan diseases. Cardiol believes there is a similar opportunity to fast track the development of its CardiolRx formulation as an orphan drug for the treatment of 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 U.S. college football players. 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,” said David Elsley President and CEO of Cardiol Therapeutics Inc. “The initiation of our Phase 1 clinical study represents another significant milestone for Cardiol, as we aim to position the Company at the forefront of heart failure research.” |