Company Makes Long-term Commitment to Outcomes Research in HCM
SOUTH SAN FRANCISCO, Calif., Aug. 18, 2020 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq:CYTK) today announced a $1 million grant and four-year partnership with the HCM Registry (HCMR), a global registry of patients with hypertrophic cardiomyopathy (HCM) focused on improving predictive measures of risk for complications and identifying biomarkers associated with adverse clinical outcomes. The HCMR was designed as the first prospective multinational registry to identify novel prognostic markers in HCM, including CMR markers of fibrosis, genetic markers, and biomarkers. It has been funded to date by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health (Grant number: U01 HL117006-01A1) and is being conducted by the University of Virginia and the University of Oxford. As an industry sponsor, Cytokinetics will join the HCMR Steering Committee in an observational capacity.
“We are pleased to partner with the HCM Registry to support better understandings of predictive risk factors for developing complications associated with living with HCM,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “HCM can severely impact the daily lives of those diagnosed with the condition. Our long-term commitment to this important initiative is aligned with our dedication to outcomes research alongside our own drug development in the interests of patient-centric engagement and improved healthspan.”
The HCMR is a prospective, observational study that enrolled 2,755 participants from 44 sites in six countries in North America and Europe who will be followed for at least five years and up to 10. Enrollment began in 2014 and completed in 2017. Primary outcome measures include cardiac death, aborted sudden cardiac death, heart transplant and left ventricular assist device placement. Secondary outcome measures include all-cause mortality, ventricular tachyarrhythmias, hospitalization for heart failure, atrial fibrillation and stroke. The results of the study will help predict the risk of developing complications associated with HCM and provide evidence to inform better treatment decisions. Additional information is available at www.clinicaltrials.gov/ct2/show/NCT01915615.
About Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is an inherited cardiovascular disorder in which the heart muscle (myocardium) becomes abnormally thick (hypertrophied). The thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller and stiffer, and thus the ventricle becomes less able to relax and fill with blood. In the majority of patients, thickening of the heart muscle in the left ventricular outflow tract obstructs the flow of blood out of the heart. This ultimately limits the heart’s pumping function, resulting in symptoms including chest pain, dizziness, shortness of breath, or fainting during physical activity. A subset of patients with HCM are at high risk of progressive disease which can lead to ventricular arrhythmias, atrial fibrillation, stroke, heart failure and sudden cardiac death. There are no current medical treatments that directly address the hypercontractility that underlies HCM.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA) for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is considering potential advancement of reldesemtiv to Phase 3. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to research, develop and commercialize other novel mechanism skeletal sarcomere activators (excluding FSTAs). Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies (HCM). Cytokinetics has granted Ji Xing Pharmaceuticals Limited an exclusive license to develop and commercialize CK-274 in China and Taiwan, in accordance with Cytokinetics’ planned global registration programs. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.
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Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities of Cytokinetics’ product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlined in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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Cytokinetics
Diane Weiser
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(415) 290-7757
