SOUTH SAN FRANCISCO, Calif., Dec. 20, 2024 (GLOBE NEWSWIRE) — Cytokinetics (NASDAQ:), Incorporated (Nasdaq: CYTK) today announced that Sanofi (NASDAQ:) will acquire exclusive rights to develop and market aficamten from Corxel Pharmaceuticals (CORXEL) for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. Aficamten is next in the cardiac myosin inhibitor class for potential treatment of patients with HCM.
In 2020, CORXEL (formerly Ji Xing) acquired the rights to develop and market aficamten in Greater China (including mainland China, Hong Kong SAR and Macau SAR, and Taiwan) from Cytokinetics in accordance and Cytokinetics global registry systems. Aficamten has received Breakthrough Therapy designation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the China National Drug Testing Institute. Medical (TASE:) The FDA recently accepted a New Drug Application for aficamten tablets for the treatment of oHCM for Priority Review.
Sanofi will now acquire CORXEL's aficamten-related rights in Greater China for an undisclosed amount. Cytokinetics remains eligible to receive up to $150 million in development and marketing payments from Sanofi and royalties on downstream sales of aficamten in Greater China. Cytokinetics is also now eligible for undisclosed additional payments in connection with the execution of the agreement between Sanofi and CORXEL.
We have enjoyed a productive partnership with CORXEL and appreciate everything they have done to advance aficamten in Greater China, said Robert I. Blum, Cytokinetics President and CEO. We now look forward to working with Sanofi with the shared goal of expanding their cardiovascular expertise and expanding the reach of aficamten to patients suffering from HCM throughout Greater China.
About Aficamten
Aficamten is a selective research program, a small molecule cardiac myosin inhibitor found after an extensive process of chemical optimization that was carried out with care for the description of the treatment and pharmacokinetic properties and as it can translate into a class-in-class possibility for clinical development. Aficamten is designed to reduce the number of actin-myosin cross-bridges during each cardiac cycle and therefore suppress myocardial hypercontractility associated with hypertrophic cardiomyopathy (HCM). In previous models, aficamten reduced myocardial contractility by binding directly to cardiac myosin in a unique and selective allosteric binding site, thereby preventing myosin from entering the force-generating state.
The development process of aficamten evaluates its potential as a treatment that improves functional capacity and reduces symptoms in patients with HCM and its long-term effects on cardiovascular structure and function. Aficamten was evaluated in SEQUOIA-HCM (Safety, Efficacy, and Evaluation of the Inhibitory Effect of Aficamten in HCM), a pivotal Phase 3 clinical trial in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Aficamten has received Breakthrough Therapy designation for the treatment of HCM with troublesome symptoms from the US Food & Drug Administration (FDA). The FDA recently accepted the company's new drug application (NDA) for aficamten, for the treatment of obstructive hypertrophic cardiomyopathy and assigned the NDA a Prescription Drug User Fee Act target date of September 26, 2025. Cytokinetics also recently submitted an application of Marketing Authorization aficamten from the European Medicines Agency.
Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared with metoprolol as monotherapy in patients with refractory HCM, ACACIA-HCM, a Phase 3 clinical trial of -aficamten in patients with non-obstructive HCM, and CEDAR-HCM, a clinical trial of aficamten in children with HCM disruptive, and FOST-HCM, an open-label extension clinical study of aficamten in patients with HCM.
About Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle (myocardium) is abnormally thick (hypertrophied). The tightening of the heart muscle leads to the inside of the left ventricle being smaller and tighter, and thus the ventricle is less relaxed and filled with blood. This ultimately reduces the heart's pumping function, leading to reduced exercise capacity and symptoms including chest pain, dizziness, shortness of breath, or fainting during exercise. HCM is the most common monogenic cardiovascular disorder, with approximately 280,000 patients diagnosed, however, there are an additional 400,000-800,000 patients who remain undiagnosed in the US1,2,3 Two-thirds of patients with HCM have HCM obstructive, where the thickening of the heart muscle leads to obstruction of the left ventricular outflow, while one third Non-obstructive HCM, where blood flow is not affected, but the heart muscle is still thick. People with HCM are at increased risk of developing cardiovascular problems including atrial fibrillation, stroke and mitral valve disease.4 People with HCM are at risk of fatal ventricular arrhythmias and are one of the leading causes of sudden cardiac death in young people. or athletes.5 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure requiring heart surgery.
About Cytokinetics
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing drug candidates that target muscle biology as potential treatments for rare diseases where heart muscle function is affected. As a leader in muscle biology and muscle function technology, the company develops small molecule drug candidates specifically designed to affect myocardial muscle function and contractility. Cytokinetics is studying the possible marketing of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, a pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being tested in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, for patients with heart failure and a very low ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor and with a mechanism of action different from aficamten, for possible treatment of heart failure. and preserved ejection fraction (HFpEF) and CK-089, a rapid skeletal muscle troponin activator with potential therapeutic application in certain types of muscular dystrophy and other conditions of muscle dysfunction.
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Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Debt Reform Act of 1995 (the Act). Cytokinetics disclaims any intention or obligation to update these forward-looking statements and claims the protection of the Safe Harbor Act in forward-looking statements. 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, potential difficulties or delays in the development, testing, regulatory approval of trial initiation, development or commercialization of the product or manufacturing, or production of drug candidates. Cytokinetics that may slow or prevent clinical development or product approval; patient enrollment or the conduct of clinical trials may be difficult or delayed; Cytokinetics drug candidates may have side effects or insufficient therapeutic efficacy; the FDA or foreign regulatory agencies may delay or restrict Cytokinetics' ability to conduct clinical trials; Cytokinetics may not be able to obtain or maintain patent or trade secret protection for intellectual property; standards of care may change, rendering Cytokinetics drug candidates obsolete; competing products or alternative therapies may be developed by others for the treatment of indications that Cytokinetics' drug candidates and potential drug candidates may target; and risks and uncertainties related to the timing and receipt of payments from its counterparties. For additional information about these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission, specifically under the heading Risk Factors in Cytokinetics' last quarterly report on Form 10-Q.
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References
- CVrg: Heart failure 2020-2029, p 44; Maron et al. 2013 DOI: 10.1016/S0140-6736(12)60397-3; Maron et al 2018 10.1056/NEJMra1710575
- Symphony Health 2016-2021 DoF Patient Claims data;
- Maron MS, Hellawell JL, Lucove JC, Farzaneh-Far R, Olivotto I. Incidence of Clinically Diagnosed Hypertrophic Cardiomyopathy in the United States. I am J Cardiol. 2016; 15;117(10):1651-1654.
- Gersh, BJ, Maron, BJ, Bonow, RO, Dearani, JA, Fifer, MA, Link, MS, et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. Report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260.
- Hong Y, Su WW, Li X. Risk factors for sudden cardiac death in hypertrophic cardiomyopathy. Current Opinion in Cardiology. 2022 Jan 1;37(1):15-21
Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757
Source: Cytokinetics, Incorporated