Cytokinetics Announces Three Presentations at the International Symposium on ALS/MND

Rhea-AI Summary

Cytokinetics (Nasdaq: CYTK) announced three poster presentations at the 31st International Symposium on ALS/MND, scheduled from December 9-11, 2020. Highlights include a Phase 3 trial design for reldesemtiv targeting ALS, and insights from previous trials regarding patient characteristics and drug development input from ALS patients and caregivers. The company is advancing its drug candidates, including omecamtiv mecarbil for heart failure and CK-274 for hypertrophic cardiomyopathies, indicating potential growth opportunities.

Positive

• Cytokinetics is advancing reldesemtiv to Phase 3, showing progress in ALS treatment.
• Omechamtiv mecarbil shows positive results in Phase 3, indicating robust pipeline potential.
• Engagement with ALS patients and caregivers may enhance drug development relevance.

Negative

• None.

SOUTH SAN FRANCISCO, Calif., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced three poster presentations at the 31^st International Symposium on ALS/MND taking place online from December 9 – December 11, 2020.

Title: A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS): COURAGE-ALS Trial Design
Session: Live Poster Session A
Date: December 9, 2020
Theme: 09 – Clinical Trials and Trial Design
Presentation Time: 5:10 – 5:50 PM GMT
Poster Number: CLT-04
Poster Presenter: Jeremy M. Shefner, M.D., Ph.D., Lead Investigator of FORTITUDE-ALS, Professor and Chair of Neurology at Barrow Neurological Institute, and Professor and Executive Chair of Neurology at the University of Arizona, Phoenix

Title: Impact of Patient Characteristics on Effect Size in FORTITUDE-ALS
Session: Live Poster Session B
Date: December 10, 2020
Theme: 09 – Clinical Trials and Trial Design
Presentation Time: 5:10 – 5:50 PM GMT
Poster Number: CLT-17
Poster Presenter: Jeremy M. Shefner, M.D., Ph.D., Lead Investigator of FORTITUDE-ALS, Professor and Chair of Neurology at Barrow Neurological Institute, and Professor and Executive Chair of Neurology at the University of Arizona, Phoenix

Title: People Living with ALS and Their Caregivers’ Input into Drug Development in Europe
Session: Live Poster Session C
Theme: 13 – Clinical Management, Support and Information
Date: December 11, 2020
Presentation Time: 12:05 – 12:50 PM GMT
Poster Number: CMS-33
Poster Presenter: Miriam Galvin, Ph.D., Academic Unit of Neurology, Trinity Biomedical Sciences Institute, Trinity College Dublin

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 potential benefits of reldesemtiv, including its ability to represent an additive and complementary approach to increase muscle function; Cytokinetics’ and its partners’ research and development activities; the timing of enrollment of patients in Cytokinetics’ and its partners’ clinical trials; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics’ 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; patient enrollment for or conduct of clinical trials may be difficult or delayed; 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; and Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Astellas’ decisions with respect to the design, initiation, conduct, timing and continuation of development activities for reldesemtiv; 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) 290-7757

FAQ

What is the significance of CYTK's poster presentations at the ALS/MND symposium?

Cytokinetics' poster presentations highlight advances in their ALS treatment candidate, reldesemtiv, and insights into patient needs, potentially enhancing their drug development strategy.

What clinical trials is Cytokinetics currently involved with?

Cytokinetics is conducting the Phase 3 COURAGE-ALS trial for reldesemtiv, and the METEORIC-HF and REDWOOD-HCM trials for omecamtiv mecarbil and CK-274, respectively.

When are the poster presentations scheduled at the ALS/MND symposium?

The poster presentations are scheduled for December 9-11, 2020, with specific sessions for each presentation on different days.

What is the expected outcome of the trials involving <b>reldesemtiv</b>?

Cytokinetics aims for reldesemtiv to demonstrate efficacy and safety in ALS patients, potentially advancing it to regulatory review and market introduction.