Cytokinetics Announces Start of Open-Label Extension Study for Patients Completing REDWOOD-HCM
May 06 2021 - 7:30AM
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:CytokineticsDiane WeiserSenior Vice
President, Corporate Communications, Investor Relations(415)
290-7757
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