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Cardiol Therapeutics Announces Completion of Phase I Clinical Study of CardiolRx(TM)
Study results are expected to support the Company's plans to file an IND application with the ...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Cardiol Therapeutics Announces Completion of Phase I Clinical Study of CardiolRx(TM)Study results are expected to support the Company's plans to file an IND application with the FDA for a Phase II clinical trial in acute myocarditisOakville, Ontario--(Newsfile Corp. - December 22, 2020) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) (\"Cardiol\" or the \"Company\"), a clinical-stage biotechnology company focused on developing innovative therapies for inflammatory heart disease, is pleased to announce completion of the Company's Health Canada approved Phase I clinical study of CardiolRx™. CardiolRx is an ultra-pure, extra strength cannabidiol oral formulation that is pharmaceutically produced, manufactured under cGMP, and THC-free (<10 ppm).Cardiol's Phase I double-blind, placebo-controlled, randomized study was designed to assess safety, tolerability, and pharmacokinetics of single, followed by multiple day ascending doses of CardiolRx administered orally to 52 healthy adult subjects, both in the fasting and fed states. The therapy was shown to be generally well tolerated with no serious adverse events reported in the study and 51 subjects completed all requirements of the study protocol. By measuring standard safety parameters and the pharmacokinetics of CardiolRx, including the degree of drug absorption and resulting blood levels at escalating doses, the Phase 1 study will provide important information to optimize dosing levels. The results of the study are expected in early Q1, 2021, and will form an integral part of the Company's planned IND application with the FDA for an international Phase II clinical trial in acute myocarditis. Acute myocarditis is an inflammatory condition of the heart that represents a leading cause of sudden cardiac death in children and otherwise healthy young adults. The most common cause of acute myocarditis is a viral infection of the heart tissue which is initially responsible for the inflammation. 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.In the United States, an orphan drug designation is granted f...