Cytokinetics
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.
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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 Reldesemtiv (all in development) |
Website | www |
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.[1] Operations began in 1998.
Initially, Cytokinetics focused on the possible pharmacological targets and areas of application of drugs based on cytoskeletal proteins.[1]
In 2004 the company completed its initial public offering (IPO).[2]
In January 2007, Cytokinetics named Robert I. Blum as President and CEO.[3]
Products
Tirasemtiv is a fast skeletal muscle troponin activator (FSTA). Tirasemtiv received fast track status[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
- "Cytokinetics: Keeping Its Sights On Independence". Life Science Leader. Retrieved 2020-06-24.
- "Cytokinetics Inc (CYTK) IPO." Nasdaq. 29 Apr 2004
- "New CEO at Cytokinetics." San Francisco Business Times. 22 Jan 2007.
- 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.
- "Cytokinetics (CYTK) Proposed Muscle Troponin Activator Now on FDA's Fast Track." Street Insider 19 April 2012.
- US Food & Drug Administration Orphan Drug
- 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
- Azevedo, M. "Cytokinetics Enrolls 700 ALS Patients in Phase 3 Study of Tirasemtiv." ALS News Today 23 August 2016.
- Carrol, John. "Cytokinetics axes lead drug after it implodes in a PhIII muscle trial for ALS, shares crater." Endpoints News. November 21, 2017.
- Feuerstein, Adam. "Effective treatments for ALS remain elusive after key clinical trial fails." STAT. November 21, 2017.
- "BRIEF-Cytokinetics Inc announces negative results from VITALITY-ALS." Reuters. November 21, 2017.
- "A Study for Patients Who Completed VITALITY-ALS (CY 4031) (VIGOR-ALS)." ClinicalTrials.gov. 12 October 2016
- Penberthy, W T. "Omencamtiv Mecarbil Improves Symptoms in Patients with Moderate to Severe Heart Failure." MD Magazine. 18 Sept 2016.
- Casey, T. "Oral heart failure medication proves safe, effective in Phase 2 trial." Cardiovascular Business. 5 Dec 2015.
- "Registrational Study with Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure with Reduced Ejection Fraction (GALACTIC-HF)." ClinicalTrials.gov. June 2017.
- Holley, D. "Royalty Pharma Pays $90M to Cytokinetics for Heart Drug Royalties." Xconomy. 2 Feb 2017.
- Kegel, Magdalena."FDA Grants Orphan Drug Designation to Cytokinetics Therapy CK-2127107 for Spinal Muscle Atrophy." SMA News Today. May 16, 2017.
- "Cytokinetics Receives FDA Orphan Drug Designation for CK-2127107 for SMA." Cure SMA. May 19, 2017.
- "Cytokinetics and Astellas Announce New Phase 2 Clinical Trial." Cure SMA. 5 Jan 2015.
- Semedo, D. "Cytokinetics Begins Phase 2 Study of Therapy for COPD Patients." COPD News Today. 5 July 2016.
- "BRIEF-Cytokinetics Q4 EPS $0.16." Reuters. 16 Feb 2017
- Pflumm, Michelle. "Cytokinetics CK-107 Muscles In at Phase 2." The ALS Research Forum. August 16, 2017.
- Mayani, Mamta. "Cytokinetics begins Phase 1b clinical trial of CK-2127107 in elderly subjects with limited mobility." Seeking Alpha. June 29, 2017.