OREANDA-NEWS. Cytokinetics, Inc. (Nasdaq:CYTK) today announced the start of a double-blind, randomized, placebo-controlled, multi-center Phase 2 clinical trial to evaluate the safety, pharmacokinetics and efficacy of omecamtiv mecarbil in Japanese subjects with heart failure and reduced ejection fraction. Omecamtiv mecarbil, a novel investigational cardiac myosin activator that increases cardiac contractility, is being developed by Amgen in collaboration with Cytokinetics for the potential treatment of heart failure.

“Advancing the clinical investigation of omecamtiv mecarbil in Japan represents an important step for our novel cardiac myosin activator program,” said Fady I. Malik, MD, PhD, Cytokinetics' Executive Vice President, Research and Development. “Omecamtiv mecarbil holds promise as a potential new treatment for patients with heart failure and we look forward to learning about its clinical application in Japanese patients.”

Phase 2 Clinical Trial Design

The ongoing Phase 2 clinical trial of omecamtiv mecarbil in Japan will evaluate approximately 80 subjects with chronic stable heart failure with reduced ejection fraction over 16 weeks randomized 1:1:1:1 to receive either placebo or omecamtiv mecarbil twice daily at 25 mg, 37.5 mg or 50 mg. Subjects randomized to 37.5 mg or 50 mg will be up-titrated using a PK-guided dose titration strategy. The primary objectives of the trial are to assess the pharmacokinetics, safety, and tolerability of omecamtiv mecarbil in Japanese subjects with heart failure and reduced ejection fraction. The secondary objective is to measure changes from baseline in systolic ejection time measured at week 16. 

About Omecamtiv Mecarbil

Omecamtiv mecarbil is a novel cardiac myosin activator. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. Cardiac myosin activators are thought to accelerate the rate-limiting step of the myosin enzymatic cycle and shift the enzymatic cycle in favor of the force-producing state. Preclinical research has shown that cardiac myosin activators increase contractility in the absence of changes in intracellular calcium in cardiac myocytes. Omecamtiv mecarbil is being developed by Amgen in collaboration with Cytokinetics. Amgen holds an exclusive, worldwide license to omecamtiv mecarbil and related compounds, subject to Cytokinetics’ specified development and commercialization rights. Les Laboratoires Servier obtained an exclusive option to commercialize omecamtiv mecarbil in Europe.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Cytokinetics’ lead drug candidate is tirasemtiv, a fast skeletal muscle troponin activator, for the potential treatment of ALS. Tirasemtiv has been granted orphan drug designation and fast track status by the U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency for the potential treatment of ALS. Cytokinetics retains the right to develop and commercialize tirasemtiv. Cytokinetics is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a novel cardiac muscle activator, for the potential treatment of heart failure. Cytokinetics is collaborating with Astellas Pharma Inc. to develop CK-2127107, a fast skeletal muscle activator, for the potential treatment of spinal muscular atrophy. Amgen holds an exclusive license worldwide to develop and commercialize omecamtiv mecarbil and Astellas holds an exclusive license worldwide to develop and commercialize CK-2127107. Both licenses are subject to Cytokinetics' specified development and commercialization participation rights.

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