Full Press Release Details
Late Breaking Clinical Trial Presentations to Feature Additional Results from SEQUOIA-HCM Related to Patient-Reported Health Status, Cardiac Structure and Function and Biomarkers
Analyses of Safety and Outcomes from FOREST-HCM Related to Withdrawal of Standard of Care Medications to be Presented
SOUTH SAN FRANCISCO, Calif., July 16, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced seven upcoming presentations, including four Late Breaking Clinical Trial presentations related to aficamten, at the European Society of Cardiology Congress 2024, taking place in London, UK from August 30, 2024 – September 2, 2024.
Late Breaking Clinical Trials
Title: Effect of Aficamten on Patient-Reported Health Status in Obstructive Hypertrophic Cardiomyopathy: Results from SEQUOIA-HCM
Presenter: John A. Spertus, M.D., M.P.H., Professor, Daniel J. Lauer Missouri Endowed Chair in Metabolic and Vascular Disease Research, Clinical Director, University of Missouri Kansas City Healthcare Institute for Innovations in Quality and Saint Luke’s Mid America Heart Institute
Date: September 1, 2024
Topic: European Society of Cardiology
Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic Stenosis
Session Type: Late-Breaking Science
Session Time: 8:15-9:45 AM BST
Presentation Time: 8:15 AM BST
Title: Impact of Aficamten on Echocardiographic Cardiac Structure and Function in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy
Presenter: Sheila Hegde, M.D., M.P.H., Cardiovascular Medicine Specialist, Division of Cardiovascular Medicine, Brigham and Women’s Hospital
Date: September 1, 2024
Topic: European Society of Cardiology
Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic Stenosis
Session Type: Late-Breaking Science
Session Time: 8:15-9:45 AM BST
Presentation Time: 8:26 AM BST
Title: Effect of Aficamten on Structure and Function in Patients with Obstructive Hypertrophic Cardiomyopathy: The SEQUOIA-HCM CMR Substudy
Presenter: Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University
Date: September 1, 2024
Topic: European Society of Cardiology
Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic Stenosis
Session Type: Late-Breaking Science
Session Time: 8:15-9:45 AM BST
Presentation Time: 8:37 AM BST
Title: Safety and Outcomes of Standard of Care Medications Withdrawal in Patients with Obstructive Hypertrophic Cardiomyopathy Treated with Aficamten in FOREST-HCM Trial
Presenter: Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University
Date: September 1, 2024
Topic: European Society of Cardiology
Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic Stenosis
Session Type: Late-Breaking Science
Session Time: 8:15-9:45 AM BST
Presentation Time: 8:48 AM BST
Title: Clinical Application of Biomarkers in Obstructive Hypertrophic Cardiomyopathy: Insights from SEQUOIA-HCM
Presenter: Caroline Coats, M.D., Ph.D., Lead Clinician, West of Scotland Inherited Cardiac Conditions Service, Honorary Senior Lecturer, School of Cardiovascular and Metabolic Health, University of Glasgow
Date: September 1, 2024
Topic: Hypertrophic Cardiomyopathy
Session Title: Novel Therapies for Hypertrophic Cardiomyopathy: Recent Developments and Future Prospects
Session Type: Advances in Science
Session Time: 8:15-9:45 AM BST
Presentation Time: 8:51 AM BST
Title: Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy: An Integrated Safety Analysis
Presenter: Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University
Date: September 1, 2024
Topic: Hypertrophic Cardiomyopathy
Session Title: Novel Therapies for Hypertrophic Cardiomyopathy: Recent Developments and Future Prospects
Session Type: Advances in Science
Session Time: 8:15-9:45 AM BST
Presentation Time: 9:09 AM BST
Title: Menopausal Status and Clinical Outcomes in Women with Heart Failure with Reduced Ejection Fraction: the GALACTIC-HF Trial
Presenter: Maria A. Pabon, M.D., Instructor of Medicine, Brigham and Women's Hospital, Harvard Medical School; Associate Director, Cardiac Imaging Core Lab
Date: September 2, 2024
Topic: Cardiovascular Disease in Women
Session Title: Cardiovascular Disease in Women
Session Type: Moderated ePosters
Session Time: 9:00-9:50 AM BST
Cytokinetics is a late-stage, specialty cardiovascular 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 cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of HFpEF, and CK-136, a cardiac troponin activator for the potential treatment HFrEF and other types of heart failure, such as right ventricular failure resulting from impaired cardiac contractility.
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 any of our other clinical trials, statements relating to the potential benefits of omecamtiv mecarbil, aficamten, or any of our other drug candidates. Cytokinetics' research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics' other drug 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, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics' drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
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Senior Vice President, Corporate Affairs