Cytokinetics, Inc. is a publicly tradedbiopharmaceutical company based in South San Francisco, California, that develops muscle activatorsand muscle inhibitors as potential treatments for people with diseases characterized by impaired or declining muscle function.
History
Cytokinetics was founded in 1997 by James Spudich, Ronald Vale, James Sabry and Lawrence S.B. Goldstein, four scientists at Stanford, UCSD, and UCSF. Operations began in 1998. Initially, Cytokinetics focused on the possible pharmacological targets and areas of application of drugs based on cytoskeletal proteins. Eventually, the company narrowed its focus to the mechanics of muscle biology. Cytokinetics develops muscle activators and muscle inhibitors to improve muscle function in patients suffering from cardiovascular and neuromuscular diseases. In 2004 the company completed its initial public offering. Amgen purchased an option on omecamtiv mecarbil in 2006, and the two companies have since extended their partnership several times. In January 2007, Cytokinetics named Robert I. Blum as President and CEO.
Products
Tirasemtiv was a fast skeletal muscle troponin activator that received fast track status in the U.S. in 2012. In 2017, Cytokinetics announced that the drug was no longer in development. Patients who had completed its Phase 3 clinical trial were eligible to enroll in VIGOR-ALS, an open-label extension clinical trial studying the long-term tolerability and safety of tirasemtiv. Cytokinetics is developing omecamtiv mecarbil, a cardiac muscle activator, in collaboration with Amgen for the potential treatment of heart failure. Results from the drug's Phase 2 clinical trial, COSMIC-HF, showed that omecamtiv mecarbil improved several measures of cardiac function in people with chronic heart failure. Omecamtiv mecarbil is currently being studied in GALACTIC-HF, an international Phase 3 cardiovascular outcomes study. Amgen holds an exclusive license to develop and commercialize omecamtiv mecarbil worldwide and Servier holds a sublicense in Europe and other countries. In February 2017 Cytokinetics sold to Royalty Pharma a 4.5 percent royalty on potential worldwide sales of omecamtiv mecarbil for $90 million in an upfront cash payment. In collaboration with Astellas, Cytokinetics is also developing reldesemtiv, a next-generation FSTA. In May 2017, reldesemtiv was granted orphan drug designation by the Office of Orphan Products Development of the FDA for the potential treatment of SMA, or Spinal Muscular Atrophy. In December 2019 and March 2020, the FDA and the European Medicines Agency, respectively, granted the drug orphan status for the treatment of amyotrophic lateral sclerosis. Reldesemtiv was evaluated during preclinical studies, five Phase 1 clinical trials, and two Phase 2 clinical trials. Cytokinetics had previously partnered with Astellas to share development costs for reldesemtiv, and in 2020 the agreement was changed, giving Cytokinetics exclusive control over the drug. Cytokinetics is developing CK-274, an oral, small-molecule myosin inhibitor, to treat hypertrophic cardiomyopathy.