Cytokinetics Announces Start of Open-Label Extension Study for Patients Completing REDWOOD-HCM

Rhea-AI Summary

Cytokinetics (CYTK) has initiated patient enrollment in REDWOOD-HCM OLE, an open-label extension study aimed at evaluating the long-term safety and tolerability of CK-274 in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This follows the completion of the REDWOOD-HCM Phase 2 trial. The study's primary endpoint will focus on adverse events and left ventricular ejection fraction (<50%). CK-274, a next-in-class cardiac myosin inhibitor, aims to improve the quality of life for oHCM patients, an area with limited treatment options.

Positive

• Initiation of the REDWOOD-HCM OLE study underlines Cytokinetics' commitment to developing new treatments for oHCM.
• CK-274's mechanism targets hypercontractility, potentially addressing a significant unmet medical need.

Negative

• Dependence on trial outcomes introduces risks that may affect investor confidence.
• Need for successful long-term safety data that could delay or hinder its market potential.

SOUTH SAN FRANCISCO, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first site has been activated to enroll patients in REDWOOD-HCM OLE, an open-label extension clinical study designed to assess the long-term safety and tolerability of CK-3773274 (CK-274) in patients with symptomatic obstructive HCM (oHCM). Eligible patients have completed participation in REDWOOD-HCM, the Phase 2 clinical trial of CK-274, a next-in-class cardiac myosin inhibitor discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy (HCM).

“Patients with HCM confront symptoms that can severely impact their quality of life, with few treatment options available to them,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “We are pleased to be able to extend our commitment to patients who have completed participation in REDWOOD-HCM, and we look forward to assessing the long-term safety and tolerability of CK-274 in this study as well as assess changes in cardiac structure and function over time.”

REDWOOD-HCM OLE: Clinical Trial Design

REDWOOD-HCM OLE is an open-label extension clinical trial of CK-274 in patients with oHCM who completed participation in REDWOOD-HCM. The primary endpoint is the incidence of adverse events and left ventricular ejection fraction (LVEF) <50%. Secondary endpoints include measures of the long-term effects of CK-274 on left ventricular outflow tract gradient (LVOT-G), and assessments of steady-state pharmacokinetics. The trial will also include a cardiac magnetic resonance imaging sub-study to assess changes in cardiac morphology, function and fibrosis. All enrolled patients will receive CK-274. To determine an individually optimized dose, each patient will start at the lowest dose in the prespecified dose range and undergo echocardiography-guided dose titration approximately every two weeks during the first six weeks, and approximately every twelve weeks thereafter. The initial dose and the highest target dose of CK-274 are being informed by interim analyses from REDWOOD-HCM. Additional information on REDWOOD-HCM and the open-label extension trial can be found at clinicaltrials.gov.

About CK-274

CK-274 is a novel, oral, small molecule cardiac myosin inhibitor arising from an extensive chemical optimization program conducted with careful attention to therapeutic index and pharmacokinetic properties that may translate into next-in-class potential in clinical development. CK-274 was designed to reduce the hypercontractility that is associated with hypertrophic cardiomyopathy (HCM). In preclinical models, CK-274 reduces myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. CK-274 reduces the number of active actin-myosin cross bridges during each cardiac cycle and consequently reduces myocardial contractility. This mechanism of action may be therapeutically effective in conditions characterized by excessive hypercontractility, such as HCM.

In preclinical models of cardiac function, CK-274 reduced cardiac contractility in a predictable dose and exposure dependent fashion. In preclinical models of disease, CK-274 reduced compensatory cardiac hypertrophy and cardiac fibrosis. The preclinical pharmacokinetics of CK-274 were characterized, evaluated and optimized for potential ease of titration in the clinical setting.

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle (myocardium) becomes abnormally thick (hypertrophied). The thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller and stiffer, and thus the ventricle becomes less able to relax and fill with blood. This ultimately limits the heart’s pumping function, resulting in symptoms including chest pain, dizziness, shortness of breath, or fainting during physical activity. A subset of patients with HCM are at high risk of progressive disease which can lead to atrial fibrillation, stroke and death due to arrhythmias. There are no FDA approved medical treatments that directly address the hypercontractility that underlies HCM.

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 preparing for the potential advancement of reldesemtiv to a Phase 3 clinical trial in 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.

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 the potential benefits of CK-274; Cytokinetics’ research and development activities; the timing of enrollment of patients in Cytokinetics’ 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’ 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

FAQ

What is the purpose of the REDWOOD-HCM OLE trial for Cytokinetics (CYTK)?

The REDWOOD-HCM OLE trial aims to evaluate the long-term safety and tolerability of CK-274 in patients with obstructive hypertrophic cardiomyopathy.

What are the primary endpoints of the REDWOOD-HCM OLE study?

The primary endpoints include the incidence of adverse events and measuring left ventricular ejection fraction (LVEF) less than 50%.

What is CK-274 and its significance in the treatment of HCM?

CK-274 is a next-in-class cardiac myosin inhibitor designed to reduce hypercontractility in patients with hypertrophic cardiomyopathy, addressing a significant unmet medical need.

When did Cytokinetics (CYTK) announce the activation of the REDWOOD-HCM OLE site?

Cytokinetics announced the activation on May 6, 2021.