Cytokinetics Announces Results From REDWOOD-HCM and GALACTIC-HF to Be Presented in Late Breaking Clinical Trials Session at the HFSA Annual Scientific Meeting
Full Results from REDWOOD-HCM Expand on Positive Topline Results of Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy
Additional Results from GALACTIC-HF Assess the Effect of Omecamtiv Mecarbil in Black Patients with Heart Failure with Reduced Ejection Fraction
SOUTH SAN FRANCISCO, Calif., Aug. 31, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the full results from REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial of aficamten in patients with hypertrophic cardiomyopathy (HCM), and additional results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil on Black patients with heart failure with reduced ejection fraction (HFrEF), have each been accepted for presentation in a Late Breaking Clinical Trials session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, taking place in Denver, CO, and virtually online from September 10-13, 2021.
Title: REDWOOD-HCM: A Randomized, Double-blind, Placebo-controlled, Dose-finding Trial of the Cardiac Myosin Inhibitor, Aficamten, In Obstructive Hypertrophic Cardiomyopathy
Presenter: Marty Maron, M.D., Director, Hypertrophic Cardiomyopathy Center; Director, Cardiac CT and MRI; Tufts University School of Medicine, and Principal Investigator of REDWOOD-HCM
Date: September 12, 2021
Session Title: Late Breaking Clinical Trials I
Session Number: 16
Session Time: 9:45 – 11:15 AM Mountain Time
Presentation Time: 10:15 – 10:25 AM Mountain Time
Location: Colorado A
Title: Effect of Omecamtiv Mecarbil In Black Patients with Heart Failure with Reduced Ejection Fraction: Insights from the GALACTIC-HF Trial
Presenter: David E. Lanfear, M.D., FACC, Section Head, Advanced Heart Failure and Transplant Cardiology; Co-Director, Center for Individualized and Genomic Medicine Research, Henry Ford Hospital
Date: September 12, 2021
Session Title: Late Breaking Clinical Trials I
Session Number: 16
Session Time: 9:45 – 11:15 AM Mountain Time
Presentation Time: 10:00 – 10:10 AM Mountain Time
Location: Colorado A
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 preparing a U.S. NDA submission of omecamtiv mecarbil, its novel cardiac muscle activator, following positive results from GALACTIC-HF, a large, international Phase 3 clinical trial in patients with heart failure. Cytokinetics is conducting METEORIC-HF, a second Phase 3 clinical trial of omecamtiv mecarbil. Cytokinetics is also developing aficamten, a next-generation cardiac myosin inhibitor, for the potential treatment of hypertrophic cardiomyopathies (HCM). The company has announced positive topline results from Cohorts 1 and 2 in REDWOOD-HCM, a Phase 2 clinical trial of aficamten in patients with obstructive HCM. Cytokinetics expects to start a Phase 3 clinical trial of aficamten in patients with obstructive HCM in Q4 2021. Cytokinetics is also developing reldesemtiv, a fast skeletal muscle troponin activator, currently the subject of COURAGE-ALS, a Phase 3 clinical trial in patients with ALS. 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 the REDWOOD-HCM, GALACTIC-HF, or 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.
Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Communications, Investor Relations
(415) 290-7757
