Cytokinetics

Cytokinetics
Public company
Traded as NASDAQ: CYTK
S&P 600 Component
Industry Biotechnology industry
Founded 1997
Founders James Spudich, Ronald Vale, James Sabry, and Lawrence S.B. Goldstein
Headquarters South San Francisco, California, United States of America
Products Tirasemtiv, Omecamtiv Mecarbil, and CK-2127107 (all in development)
Website www.cytokinetics.com/

Cytokinetics, Inc. is a publicly traded biopharmaceutical company based in South San Francisco, California, that develops muscle activators 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, and operations began in 1998.

In 2004 the company completed its initial public offering (IPO).[1]

In January 2007, Cytokinetics named Robert I. Blum as President and CEO.[2]

Products

Tirasemtiv is a fast skeletal muscle troponin activator (FSTA). Tirasemtiv received fast track status[3][4][5] in the U.S. in 2012, and was designated an orphan drug[6] by the Food and Drug Administration, as well as an orphan medicinal product[7] by the European Medicines Agency for ALS. Tirasemtiv was the subject of VITALITY-ALS, an international Phase 3 clinical trial studying its effects on respiratory function and muscle strength in people with ALS.[8] VITALITY-ALS did not meet the primary endpoint and Cytokinetics announced in 2017 that the company is suspending development of tirasemtiv.[9][10][11] Patients who completed VITALITY-ALS were eligible to enroll in VIGOR-ALS, an open-label extension clinical trial studying the long-term tolerability and safety of tirasemtiv.[12]

Cytokinetics is developing omecamtiv mecarbil, a cardiac muscle activator, in collaboration with Amgen for the potential treatment of heart failure.[13][14] Results from the 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.[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]

In collaboration with Astellas, Cytokinetics is also developing reldesemtiv (previously known as CK-2127107), a next-generation FSTA. Reldesemtiv has been granted orphan drug designation by the FDA for the potential treatment of SMA, or Spinal Muscular Atrophy.[17][18] It is currently being studied in three Phase 2 clinical trials, one in spinal muscular atrophy (SMA), one in chronic obstructive pulmonary disease (COPD), and one in ALS, as well as a Phase 1b clinical trial in elderly adults with limited mobility.[19][20][21][22][23] Astellas holds an exclusive license for the development and commercialization of reldesemtiv worldwide.

References

  1. ↑ "Cytokinetics Inc (CYTK) IPO." Nasdaq. 29 Apr 2004
  2. ↑ "New CEO at Cytokinetics." San Francisco Business Times. 22 Jan 2007.
  3. ↑ Russell, AJ, et al. "Activation of fast skeletal muscle troponin as a potential therapeutic approach for treating neuromuscular diseases." Nature Medicine. 19 Feb 2012;18(3):452-5.
  4. ↑ "Cytokinetics (CYTK) Proposed Muscle Troponin Activator Now on FDA's Fast Track." Street Insider 19 April 2012.
  5. ↑ Staley, E. "Cytokinetics Announces CK-2017357 Receives Fast Track Designation from the FDA for the Potential Treatment of Amyotrophic Lateral Sclerosis." Benzinga 19 April 2012
  6. ↑ US Food & Drug Administration Orphan Drug
  7. ↑ Committee for Orphan Medicinal Products. "Public summary of opinion on orphan designation 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one for the treatment of amyotrophic lateral sclerosis." European Medicines Agency 12 March 2015
  8. ↑ Azevedo, M. "Cytokinetics Enrolls 700 ALS Patients in Phase 3 Study of Tirasemtiv." ALS News Today 23 August 2016.
  9. ↑ Carrol, John. "Cytokinetics axes lead drug after it implodes in a PhIII muscle trial for ALS, shares crater." Endpoints News. November 21, 2017.
  10. ↑ Feuerstein, Adam. "Effective treatments for ALS remain elusive after key clinical trial fails." STAT. November 21, 2017.
  11. ↑ "BRIEF-Cytokinetics Inc announces negative results from VITALITY-ALS." Reuters. November 21, 2017.
  12. ↑ "A Study for Patients Who Completed VITALITY-ALS (CY 4031) (VIGOR-ALS)." ClinicalTrials.gov. 12 October 2016
  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. ↑ "Registrational Study with Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure with Reduced Ejection Fraction (GALACTIC-HF)." ClinicalTrials.gov. June 2017.
  16. ↑ Holley, D. "Royalty Pharma Pays $90M to Cytokinetics for Heart Drug Royalties." Xconomy. 2 Feb 2017.
  17. ↑ Kegel, Magdalena."FDA Grants Orphan Drug Designation to Cytokinetics Therapy CK-2127107 for Spinal Muscle Atrophy." SMA News Today. May 16, 2017.
  18. ↑ "Cytokinetics Receives FDA Orphan Drug Designation for CK-2127107 for SMA." Cure SMA. May 19, 2017.
  19. ↑ "Cytokinetics and Astellas Announce New Phase 2 Clinical Trial." Cure SMA. 5 Jan 2015.
  20. ↑ Semedo, D. "Cytokinetics Begins Phase 2 Study of Therapy for COPD Patients." COPD News Today. 5 July 2016.
  21. ↑ "BRIEF-Cytokinetics Q4 EPS $0.16." Reuters. 16 Feb 2017
  22. ↑ Pflumm, Michelle. "Cytokinetics CK-107 Muscles In at Phase 2." The ALS Research Forum. August 16, 2017.
  23. ↑ Mayani, Mamta. "Cytokinetics begins Phase 1b clinical trial of CK-2127107 in elderly subjects with limited mobility." Seeking Alpha. June 29, 2017.

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