Item 8.01. Other Events.
On May 5, 2021 Cytokinetics, Incorporated (the “Registrant”
or “Cytokinetics”) 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”).
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 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
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 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
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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 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.