Profile: Cytokinetics Inc (CYTK.O)
16 Aug 2019
Cytokinetics, Incorporated, incorporated on August 5, 1997, is a late-stage biopharmaceutical company. The Company is 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. It is focused on the discovery and development of small molecule therapeutics that modulate muscle function for the treatment of serious diseases and medical conditions. The Company is developing small molecule drug candidates, which are specifically engineered to increase muscle function and contractility. The Company's drug candidates, which are in clinical development include tirasemtiv, CK-2127107 and omecamtiv mecarbil.
The Company's lead drug candidate from its skeletal muscle contractility program, tirasemtiv, is a skeletal muscle troponin activator. The Company is developing tirasemtiv drug candidate for the treatment of Amyotrophic lateral sclerosis (ALS). It has conducted a Phase II clinical trials program for tirasemtiv, including a Phase IIb clinical trial in patients with ALS, known as Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS (BENEFIT-ALS). The Company has also started Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS (VITALITY-ALS), a multi-national, randomized, double-blind, placebo-controlled trial, which is designed to assess Tirasemtiv effects versus placebo on measures of respiratory function and muscle strength in people with ALS. Tirasemtiv has been granted orphan drug designation and fast track status by the United States Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency for the potential treatment of ALS.
CK-2127107 is a skeletal muscle troponin activator. The Company is developing CK-2127107 for the potential treatment of spinal muscular atrophy (SMA), chronic obstructive pulmonary disease (COPD) and ALS. The Company has started enrollment of the Phase II clinical trial of CK-2127107 in patients with SMA, which is designed to assess effects of CK-2127107 on multiple measures of muscle function in both ambulatory and non-ambulatory patients with SMA. It has also started a Phase II clinical trial of CK-2127107 in patients with COPD. CK-2127107 is also being evaluated for potential use in other indications associated with muscle weakness.
The Company's lead drug candidate from its cardiac muscle contractility program, omecamtiv mecarbil, is a cardiac muscle myosin activator. Its omecamtiv mecarbil is being investigated as a potential treatment for heart failure. The Company has conducted Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF), a Phase II, double-blind, randomized, placebo-controlled, multicenter, clinical trial, which is designed to assess the pharmacokinetics and tolerability of omecamtiv mecarbil dosed orally in patients with heart failure and left ventricular systolic dysfunction, as well as its effects on echocardiographic measures of cardiac function. The Company has conducted a Phase IIb clinical trial, known as Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure (ATOMIC-AHF), for intravenous formulation of omecamtiv mecarbil. ATOMIC-AHF evaluates the safety and efficacy of omecamtiv mecarbil in patients with left ventricular systolic dysfunction who are hospitalized with acute heart failure.
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