CardiolRx is an ultra-pure, extra strength cannabidiol oral formulation that is pharmaceutically produced, manufactured under cGMP, and THC-free (less than 10 ppm).
During Phase I – a double-blind, placebo-controlled randomized study – participants received single, then multiple day ascending doses of CardiolRx administered orally, both in the fasting and fed states.
READ: Cardiol Therapeutics selects Worldwide Clinical Trials as its CRO for Phase II/III study of CardiolRx
In a statement, Cardiol said that the treatment was “generally well tolerated” with no serious adverse events reported in the 51 subjects that completed all requirements of the study protocol.
Phase I will help determine optimal dosing levels through measuring standard safety parameters and the pharmacokinetics of the treatment, including the degree of drug absorption and resulting blood levels at higher doses, the Oakville-based firm told shareholders.
Full results from Phase I are expected in early 2021.
The data will form a key part of Cardiol’s planned investigational new drug (IND) application with the US Food and Drug Administration for an international Phase II trial in acute myocarditis, an inflammatory heart condition that can lead to sudden death in otherwise healthy children and adults.
“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,” Cardiol said in a statement.
In the US, orphan drug designations are given to pharmaceuticals being developed to treat conditions that affect less than 200,000 people. The status means CardiolRx would be eligible for accelerated marketing approvals and other incentives such as longer market exclusivity in the US and the European Union.
Cardiol is a clinical-stage biotechnology company that is developing anti-inflammatory therapies to treat cardiovascular disease.
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