Cardiol Therapeutics Inc (TSE:CRDL) (OTCMKTS:CRTPF), which is developing medicines for heart disease, marked a major step forward on Thursday, with the green light from Health Canada to carry out a Phase 1 study on its pure cannabidiol formulation, which is THC free (<5ppm).
The firm, which is developing innovative therapies for heart diseases, including acute myocarditis, plans to start the study in the second quarter of this year.
There is a growing demand for a cannabidiol formulation that does not contain THC.
Brain effects unknown
Both the College of Physicians and Surgeons of Ontario and the Canadian Paediatric Society recommend that physicians do not expose young people under the age of 25 to THC, as its effects on brain development are unknown.
The Phase 1 study will measure the blood levels of drug following single and multiple doses of the extra strength 100 mg/ml concentration in up to up to 55 healthy subjects.
It will also measure standard safety parameters at escalating doses to help select the optimal dosing levels for a planned international Phase 2 study for acute myocarditis — a leading cause of sudden cardiac death in children and young adults.
"Receiving Health Canada's No Objection Letter to conduct a Phase 1 study is an important development for Cardiol, as this will be the first study designed to investigate safety and dosing levels of our high concentration cannabidiol formulation developed for patients who should not be exposed to THC," said David Elsley, the president and CEO of Cardiol Therapeutics in a statement.
Important data
"The study is expected to provide important data to support the commercial and clinical development of this unique THC free (<5ppm) product which contains the same cannabidiol concentration as the medicine approved by the FDA for rare forms of paediatric epilepsy."
Cardiol plans to enter the Canadian medicinal cannabinoid market, which is estimated to be worth C$1.2 billion annually, and is looking to address the largest segments — people under 25 and adults over 65 years of age — by offering what it believes is the purest form of cannabidiol in the world.
Shares in Toronto eased 1.69% to stand at C$3.49 each.
Contact the author at giles@proactiveinvestors.com