Cytokinetics

Cytokinetics, Inc. is a publicly traded biopharmaceutical company based in South San Francisco, California, that develops muscle activators and muscle inhibitors as potential treatments for people with diseases characterized by impaired or declining muscle function.

Cytokinetics
TypePublic company
NASDAQ: CYTK
S&P 600 Component
IndustryBiotechnology industry
Founded1997
Founders
Headquarters
South San Francisco, California
,
United States of America
Key people
  • Robert Blum (President & CEO)
  • Fady Malik (Executive VP)[1]
  • Ching Jaw (CFO)
  • Stuart Kupfer (CMO)
  • Robert Califf (Board of Directors)[2]
Products
Websitewww.cytokinetics.com

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.[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]

Products

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]

References
  1. "Reldesemtiv Wins ALS Treatment Orphan Drug Designation From EMA". Retrieved 2020-08-01.
  2. "Former FDA head Gottlieb joins Pfizer board". Biopharmdive.
  3. "Cytokinetics: Keeping Its Sights On Independence". Life Science Leader. Retrieved 2020-06-24.
  4. "Myokardia posts positive phase III for mavacamten". www.bioworld.com. Retrieved 2020-07-06.
  5. "3 Biotech Stocks Surging on Positive Results". finance.yahoo.com. Retrieved 2020-07-06.
  6. "Cytokinetics receives FDA orphan drug status for Ck-2127107 to treat SMA". Pharmaceutical Technology. 2017-05-16. Retrieved 2020-07-15.
  7. "Healthy data for Cytokinetics' HCM candidate". www.ddn-news.com. Retrieved 2020-07-09.
  8. "Cytokinetics Inc (CYTK) IPO." Nasdaq. 29 Apr 2004
  9. "New CEO at Cytokinetics." San Francisco Business Times. 22 Jan 2007.
  10. "Cytokinetics: Keeping Its Sights On Independence". www.lifescienceleader.com. Retrieved 2020-11-19.
  11. "Astellas bites off $490M deal to develop muscle drugs with Cytokinetics". FierceBiotech. Retrieved 2020-10-28.
  12. "Cytokinetics nabs Chinese partner, up to $450M as CV becomes company focus". Endpoints News. Retrieved 2020-10-22.
  13. Penberthy, W T. "Omencamtiv Mecarbil Improves Symptoms in Patients with Moderate to Severe Heart Failure." MD Magazine. 18 Sept 2016.
  14. Casey, T. "Oral heart failure medication proves safe, effective in Phase 2 trial." Cardiovascular Business. 5 Dec 2015.
  15. "Novel myosin activator for HFrEF nets FDA fast track designation". www.healio.com. Retrieved 2020-08-27.
  16. Holley, D. "Royalty Pharma Pays $90M to Cytokinetics for Heart Drug Royalties." Xconomy. 2 Feb 2017.
  17. "Amgen, Cytokinetics and Servier announce start of METEORIC-HF, the second Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure". www.worldpharmanews.com. Retrieved 2020-08-11.
  18. Teerlink, John R.; Diaz, Rafael; Felker, G. Michael; McMurray, John J. V.; Metra, Marco; Solomon, Scott D.; Legg, Jason C.; Büchele, Gustavo; Varin, Claire; Kurtz, Christopher E.; Malik, Fady I. (2020-04-01). "Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF". JACC: Heart Failure. 8 (4): 329–340. doi:10.1016/j.jchf.2019.12.001. ISSN 2213-1779.
  19. Kegel, Magdalena."FDA Grants Orphan Drug Designation to Cytokinetics Therapy CK-2127107 for Spinal Muscle Atrophy." SMA News Today. May 16, 2017.
  20. "Cytokinetics Receives FDA Orphan Drug Designation for CK-2127107 for SMA." Cure SMA. May 19, 2017.
  21. Inacio PhD, Patricia (2019-12-19). "Reldesemtiv Earns FDA's Orphan Drug Designation for ALS Treatment". ALS News Today. Retrieved 2020-07-27.
  22. Malcom PhD, Emily. "Reldesemtiv (Formerly CK-2127107) - SMA News Today". SMA News Today. Retrieved 2020-07-27.
  23. "Peninsula drug company gets control of its ALS drug back — with money to develop it". San Francisco Business Times. Retrieved 2020-07-20.
  24. "Cytokinetics doses first subject in Phase l trial of CK-274 for HCM". Clinical Trials Arena. 2018-12-07.
  25. "Cytokinetics Announces Vision 2025 and Outlines 2020 Corporate Milestones". Cath Lab Digest. Retrieved 2020-09-01.
  26. "Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)". clinicaltrials.gov. Retrieved 2020-07-14.
  27. "Cytokinetics (CYTK) Proposed Muscle Troponin Activator Now on FDA's Fast Track." Street Insider 19 April 2012.
  28. Carrol, John. "Cytokinetics axes lead drug after it implodes in a PhIII muscle trial for ALS, shares crater." Endpoints News. November 21, 2017.
  29. Feuerstein, Adam. "Effective treatments for ALS remain elusive after key clinical trial fails." STAT. November 21, 2017.
  30. "BRIEF-Cytokinetics Inc announces negative results from VITALITY-ALS." Reuters. November 21, 2017.
  31. "A Study for Patients Who Completed VITALITY-ALS (CY 4031) (VIGOR-ALS)." ClinicalTrials.gov. 12 October 2016

Official website

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