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Cardiol Therapeutics Announces Topline Results from Phase I Single and Multiple Ascending Dose Clinical Trial of CardiolRx(TM)
Results expected to support the Company's plans to file an IND application with the FDA for a ...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Cardiol Therapeutics Announces Topline Results from Phase I Single and Multiple Ascending Dose Clinical Trial of CardiolRx(TM)Results expected to support the Company's plans to file an IND application with the FDA for a Phase II international trial in acute myocarditisOakville, Ontario--(Newsfile Corp. - April 12, 2021) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) (FSE: CT9) (\"Cardiol\" or the \"Company\"), a clinical-stage biotechnology company focused on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease (CVD), today announced topline results from a Phase I single and multiple ascending dose clinical trial of CardiolRx™, a pharmaceutically produced oral cannabidiol formulation being developed for the treatment of acute and chronic inflammation associated with heart disease.\"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, President and CEO of Cardiol Therapeutics. \"Study results support the dosing regimen being utilized in our U.S. 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, and our plans to file a IND application with the FDA for a Phase II international trial in acute myocarditis, an inflammatory condition of the heart, which remains a leading cause of sudden cardiac death in children and young adults.\"The Phase I trial was a randomized, placebo-controlled, double-blind study designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of CardiolRx at various dose levels. The study randomized 52 subjects (age range 25 to 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. Seri...