- Cardiol Therapeutics (TSX:CRDL) has received approval from Health Canada for a Phase 1 study of its cannabidiol (CBD) formulation
- The study is designed to measure blood levels of the drug after single and multiple doses
- It will also measure safety parameters at escalating doses in order to determine the optimum dosing amount
- With 100mg/mL of CBD, the extra-strength formulation does not contain THC, which is the primary psychoactive component in cannabis
- The study is due to begin in the second quarter of 2020
- Shares in Cardiol Therapeutics (CRDL) are currently down 4.51 per cent to C$3.39, with a market cap of C$88.24 million
Cardiol Therapeutics (TSX:CRDL) has received approval from Health Canada for a Phase 1 study of its CBD formulation.
The company is a developer of pharmaceutical CBD medicines for the treatment of heart diseases.
Cardiol’s study is designed to measure blood levels of CBD following single and multiple doses of the THC-free drug.
The extra-strength formulation will be tested in up to 55 healthy subjects, and will also evaluate safety parameters in escalating doses to determine the optimum dosing amount.
Commencement of the study is expected in the second quarter of 2020.
David Elsley, President and CEO of Cardiol, said that the approval is a critical step in bringing the drug to market.
“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 CBD formulation developed for patients who should not be exposed to THC.
“The study is expected to provide important data to support the commercial and clinical development of this unique THC-free product which contains the same CBD concentration as the medicine approved by the FDA for rare forms of paediatric epilepsy,” he added.
A growing demand has been seen recently for THC-free CBD formulations.
Several institutions, including the College of Physicians and Surgeons and the Canadian Paediatric Society have advised against exposing people under the age of 25 to THC.
The effect of THC on elderly patients has also been considered. The psychoactive component may have the potential for undesirable drug interactions and adverse effects of intoxication.
Cardiol says that its current focus is on entering the market, valued at approximately C$1.2 billion annually, as soon as possible.
Shares in the company are currently down 4.51 per cent to C$3.39, with a market cap of C$88.24 million at 10:03 am EST.