Cytokinetics

Cytokinetics was founded in 1997 by James Spudich, Ronald Vale, James Sabry and Lawrence S.B. Goldstein, four scientists at Stanford, UCSD, and UCSF.[3] Operations began in 1998.

Initially, Cytokinetics focused on the possible pharmacological targets and areas of application of drugs based on cytoskeletal proteins.[3] Eventually, the company narrowed its focus to the mechanics of muscle biology.[3] Cytokinetics develops muscle activators and muscle inhibitors to improve muscle function in patients suffering from cardiovascular and neuromuscular diseases.[4][5] The company’s lead muscle activator development program is for a drug called omecamtiv mecarbil, currently being studied for the potential treatment of heart failure.[3] Additional drugs include reldesemtiv, a next-generation fast skeletal muscle troponin activator, and CK-274, a small-molecule myosin inhibitor.[6][7]

In 2004 the company completed its initial public offering (IPO).[8] Amgen purchased an option on omecamtiv mecarbil in 2006, and the two companies have since extended their partnership several times.[3]

In January 2007, Cytokinetics named Robert I. Blum as President and CEO.[9] Prior to this, Blum has been involved in the company since its founding, with roles in business development, corporate development and R&D.[10]

In June 2013, Cytokinetics and Amgen expanded their licensing deal for omecamtiv mecarbil to include Japan. A week later, Cytokinetics finalized a licensing and discovery deal with Astellas to research treatment for muscle weakness and fatigue.[11]

In July 2020, Ji Xing Pharmaceuticals signed a financing deal with Cytokinetics, which included the rights to commercialize the drug designed to treat hypertrophic cardiomyopathies, CK-274, in China and certain neighboring regions.[12]

Cytokinetics is developing omecamtiv mecarbil, a cardiac muscle activator, in collaboration with Amgen for the potential treatment of heart failure.[13][14] In May 2020, omecamtiv mecarbil was granted fast track designation by the FDA for the treatment of chronic HF with reduced ejection fraction.[15] 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.[16] 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 two international Phase 3 cardiovascular outcomes studies: GALACTIC-HF and METEORIC-HF.[17] GALACTIC-HF enrolled over 8,000 patients with heart failure with reduced ejection fraction (HFrEF). It studies whether the drug, vs a placebo, reduces the risk of heart failure events and CV death when added to standard care.[18] In February 2019, Cytokinetics, Amgen, and Servier announced that METEORIC-HF, the second Phase 3 clinical trial for omecamtiv mecarbil, was open for enrollment.[17] METEORIC-HF studies the effect of the drug vs a placebo on exercise capacity in patients with heart failure with reduced ejection fraction (HFrEF).[17]

In collaboration with Astellas, Cytokinetics is also developing reldesemtiv (previously known as CK-2127107), a next-generation fast skeletal muscle troponin activator (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.[19][20][6] In December 2019 and March 2020, the FDA and the European Medicines Agency (EMA), respectively, granted the drug orphan status for the treatment of amyotrophic lateral sclerosis (ALS).[21][1] The EMA had previously granted it orphan status for the treatment of SMA.[21] Reldesemtiv was evaluated during preclinical studies, five Phase 1 clinical trials, and two Phase 2 clinical trials.[22][21] 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.[23]

Cytokinetics is developing CK-3773274 (CK-274), an oral, small-molecule myosin inhibitor, to treat hypertrophic cardiomyopathy (HCM).[4][7] The drug’s Phase 1 trial, which assessed the safety and tolerability of single and multiple oral doses, started in December 2018.[24] In September 2019, the company released the results of the study.[4][5] The drug was well-tolerated and met safety requirements.[5] REDWOOD-HCM, a phase 2 trial with patients with obstructive HCM started in January 2020.[25]

Tirasemtiv was an FSTA that received fast track status in the U.S. in 2012.[26][27] In 2017, Cytokinetics announced that the drug was no longer in development.[28][29][30] Patients who had completed its Phase 3 clinical trial, VITALITY-ALS, were eligible to enroll in VIGOR-ALS, an open-label extension clinical trial studying the long-term tolerability and safety of tirasemtiv.[31]

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