Cytokinetics Announces Additional Results From GALACTIC-HF to be Presented at the 17th Global Cardiovascular Clinical Trialists Forum

Rhea-AI Summary

Cytokinetics announced that results from the Phase 3 GALACTIC-HF trial of omecamtiv mecarbil will be presented at the Global Cardiovascular Clinical Trialists Forum on December 6, 2020. This trial aims to enhance cardiac contractility in heart failure patients. The presentation will be led by John Teerlink, M.D. Following positive outcomes from GALACTIC-HF, Cytokinetics is preparing for discussions with regulatory bodies regarding omecamtiv mecarbil and is concurrently conducting the METEORIC-HF trial.

Positive

• Positive results reported from GALACTIC-HF, a pivotal trial for omecamtiv mecarbil.
• Cytokinetics is preparing for regulatory interactions regarding omecamtiv mecarbil.
• Conducting a second Phase 3 trial (METEORIC-HF) to further evaluate omecamtiv mecarbil.

Negative

• None.

Data from Supplemental Analyses to be Shared at Clinical Trials Think Tank Meeting

SOUTH SAN FRANCISCO, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) today announced additional results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 event driven cardiovascular outcomes clinical trial of omecamtiv mecarbil, will be presented at the 17^th Global Cardiovascular Clinical Trialists Forum (CVCT) by John Teerlink, M.D., Professor of Medicine, University of California San Francisco, Director of Heart Failure, San Francisco Veterans Affairs Medical Center and Executive Committee Chair, COSMIC-HF and GALACTIC-HF. CVCT is a global invitation-only meeting of opinion leaders across clinical research, industry and regulatory authorities.

Session Title: Targeting the Vessels and the Heart: Oral Soluble Guanylate Cyclase Stimulator (Vericiguat) and Cardiac Myosin Activation (Omecamtiv Mecarbil)
Presentation Title: GALACTIC-HF Main Results
Presenter: John Teerlink, M.D., Professor of Medicine, University of California San Francisco, Director of Heart Failure, San Francisco Veterans Affairs Medical Center and Executive Committee Chair, COSMIC-HF and GALACTIC-HF
Date: Sunday, December 6, 2020
Time: 3:30 PM Central European Time

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 for regulatory interactions for 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 CK-274, a next- generation cardiac myosin inhibitor, for the potential treatment of hypertrophic cardiomyopathies (HCM). Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics is also developing reldesemtiv, a fast skeletal muscle troponin activator 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 pending ongoing regulatory interactions. 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.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.

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 GALACTIC-HF clinical trial; statements relating to the METEORIC-HF clinical trial; Cytokinetics’ activities to advance the development of omecamtiv mecarbil; the potential benefits of omecamtiv mecarbil, including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; the potential approval of omecamtiv mecarbil by the FDA or any other regulatory authority; Amgen’s fulfillment of its undertakings regarding transition of the omecamtiv mecarbil and AMG 594 programs to Cytokinetics; any decision on the part of Servier to maintain or terminate its sublicense in respect of omecamtiv mecarbil prior to the effectiveness of the termination of the Amgen-Cytokinetics collaboration; Cytokinetics' and its partners' 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' or its partners' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen's decisions and activities with respect to the transfer of rights to develop and commercialize omecamtiv mecarbil and AMG 594 to Cytokinetics; standards of care may change, rendering Cytokinetics' drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics' collaboration agreements with such partners. 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) 290-3060

FAQ

What were the main results from the GALACTIC-HF trial for CYTK?

The GALACTIC-HF trial reported positive results regarding the efficacy of omecamtiv mecarbil in enhancing cardiac contractility in heart failure patients.

When will the GALACTIC-HF results be presented for CYTK?

The results will be presented on December 6, 2020, at the Global Cardiovascular Clinical Trialists Forum.

What is the next step for CYTK following the GALACTIC-HF results?

Cytokinetics plans to engage in regulatory discussions regarding omecamtiv mecarbil and is also conducting the METEORIC-HF clinical trial.

Who is presenting the GALACTIC-HF results for CYTK?

The results will be presented by John Teerlink, M.D., a Professor of Medicine at UCSF and Director of Heart Failure.