Cardiol Therapeutics Inc. (TSE:CRDL) (OTCQX:CRTPF) (FRA:CT9) announced topline results from its Phase I clinical trial of CardiolRx, its pharmaceutically-produced oral cannabidiol formulation.
The biotechnology company said the results from the single and multiple ascending dose trial indicate that the drug was safe and well-tolerated at all dose levels, with no serious side effects reported.
As well, pharmacokinetic studies determined that blood levels of the drug tended to rise hand-in-hand with an increasing dose.
READ: Cardiol Therapeutics finishes ‘exciting’ 2020 with $14M in cash to advance its pharmaceutical pipeline
CardiolRx is being developed to treat acute and chronic inflammation associated with heart disease. Currently, the treatment is being studied as a cardioprotective therapy to reduce mortality and major cardiovascular events in coronavirus (COVID-19) patients, who have a prior history of, or risk factors for, cardiovascular disorder.
Cardiol told investors that the results are expected to support its plans to file an investigational new drug (IND) application with the US Food and Drug Administration for a Phase II international trial in acute myocarditis.
"As our study represents one of the most comprehensive Phase I clinical trials ever conducted in adults with a pharmaceutically produced cannabidiol formulation, we are pleased that the data are consistent with our expectations concerning the drug's safety, tolerability, and PK profile," said David Elsley, CEO of Cardiol Therapeutics in a statement.
No severe adverse effects
Phase I included 52 subjects divided into two groups, which were each separated into subgroups. Group A was divided into three sub-groups, each involving 12 subjects (nine active and three placebo), with each subject receiving a single dose of 5 mg/kg or 15 mg/kg of CardiolRx, in either the fed or fasted state.
Group B included two sub-groups, each involving eight subjects (six active and two placebo) with each subject receiving 5 mg/kg or 15 mg/kg twice daily for six days. Serial blood samples were taken to measure the level of cannabidiol and its two main metabolites.
Fifty-one of the 52 enrolled subjects completed all requirements of the protocol, with each subject monitored through a physical examination with vital signs, electrocardiogram to monitor cardiac time intervals, and biochemical and coagulation laboratory tests.
Cardiol told investors that despite the relatively high doses of CardiolRx administered during the study, there were no ECG or abnormal laboratory findings after six days of dosing --specifically, no elevation of liver enzymes or QTc changes were detected. Any recorded adverse events were mild or moderate in severity and were primarily related to the gastro-intestinal tract, according to the company.
The study results support the dosing regimen being utilized in its US Phase II/III clinical trial investigating the cardioprotective properties of CardiolRx in 422 hospitalized patients with COVID-19 with a prior history of, or risk factors for, cardiovascular disease, Elsley added.
Oakville, Ontario-based Cardiol is a clinical-stage biotechnology company focused on the research and clinical development of innovative anti-inflammatory therapies for the treatment of cardiovascular disease.
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