- Cardiol Therapeutics (CRDL) has shared topline results from its Phase I single and multiple ascending dose clinical trial for CardiolRx
- The Phase I trial was designed to evaluate the safety, tolerability and pharmacokinetic profile of CardiolRx
- Topline results demonstrated that CardiolRx was safe and generally well tolerated at all dose levels
- The recorded adverse events were all mild or moderate and were primarily related to the gastro-intestinal tract
- The results support a Phase II/III study in the U.S. in COVID-19 patients hospitalized with risk factors for cardiovascular disease
- Results are also expected to support a Phase II international trial for acute myocarditis
- Cardiol Therapeutics is a clinical-stage biotechnology company focused on anti-inflammatory therapies for the treatment of cardiovascular disease
- Cardiol Therapeutics (CRDL) is up o.68 per cent and is currently trading at C$4.41 per share
Cardiol Therapeutics (CRDL) has shared topline results from its Phase I single and multiple ascending dose clinical trial for CardiolRx.
CardiolRx is an oral cannabidiol formulation intended for the treatment of acute and chronic inflammation associated with heart disease.
The Phase I trial was designed to evaluate the safety, tolerability and pharmacokinetic profile of CardiolRx at various dose levels. The study randomized 52 subjects aged between 25 and 60 years to one of two groups.
In Group A, there were 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.
In Group B, there were 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.
Topline results demonstrated that CardiolRx was safe and generally well tolerated at all dose levels with no serious adverse events reported in the study. Fifty-one of the 52 subjects completed all requirements of the protocol.
There were no ECG or abnormal laboratory findings after six days of dosing; specifically, no elevation of liver enzymes or QTc changes were detected. The recorded adverse events were all mild or moderate and were primarily related to the gastro-intestinal tract.
Pharmacokinetic studies determined that blood levels of the drug generally increased with the dose. Following a single dose of CardiolRx, the area under the time-concentration curve, which represents the extent of exposure to the drug, was six to seven times higher in the fed state than the fasted state.
The findings will inform the dosing regimen in Cardiol’s Phase II/III study in the U.S. in COVID-19 patients hospitalized with risk factors for cardiovascular disease.
Results are also expected to support the company’s plans to file an IND application with the FDA for a Phase II international trial for acute myocarditis.
David Elsley, President and CEO of Cardiol Therapeutics, commented,
“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.”
Cardiol Therapeutics is a clinical-stage biotechnology company focused on anti-inflammatory therapies for the treatment of cardiovascular disease.
Cardiol Therapeutics (CRDL) is up o.68 per cent and is currently trading at C$4.41 per share as of 9:52 am ET.
