Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that
additional results from COSMIC-HF (
Chronic
Oral
Study of
Myosin Activation to
Increase
Contractility in
Heart
Failure), a Phase 2 trial evaluating omecamtiv
mecarbil in patients with chronic heart failure, were presented by
John Teerlink, M.D., Professor of Clinical Medicine, University of
California San Francisco and Director of Heart Failure, San
Francisco Veterans Affairs Medical Center, in a Moderated Poster
Session at the American College of Cardiology’s 68th Annual
Scientific Session (ACC.19) in New Orleans.
There were no statistically significant
differences in the effects of treatment with omecamtiv mecarbil
between subjects with and without atrial fibrillation (AF) on
cardiac function, including systolic ejection time and stroke
volume, as well as ventricular volumes, heart rate, and NT-proBNP
in patients. Overall, the pattern of adverse events did not appear
markedly different between treatment arms, regardless of the
presence of AF at baseline. Omecamtiv mecarbil, a novel
investigational cardiac myosin activator, is being developed for
the potential treatment of heart failure under a collaboration
between Amgen and Cytokinetics, with funding and
strategic support from Servier.
“Atrial fibrillation is a common comorbidity in
people with heart failure; its prevalence increases with increasing
heart failure severity and affects up to forty percent of those
with NYHA class IV disease,” said Fady I. Malik, MD, PhD,
Cytokinetics’ Executive Vice President, Research and Development.
“Twenty percent of patients in COSMIC-HF had both heart failure and
atrial fibrillation and we’re pleased to see that the treatment
effects and safety of omecamtiv mecarbil in this key subgroup did
not differ substantially from patients who did not have atrial
fibrillation.”
COSMIC-HF: Expansion Phase Design and
Results
The expansion phase of COSMIC-HF evaluated the
pharmacokinetics, pharmacodynamics, safety and tolerability of
oral omecamtiv mecarbil in 448 patients with chronic
heart failure and left ventricular systolic dysfunction. Patients
were randomized 1:1:1 to receive either placebo or treatment
with omecamtiv mecarbil dosed as 25 mg twice daily or 25
mg twice daily with dose escalation to 50 mg twice daily, depending
on a plasma concentration of omecamtiv mecarbil after two
weeks of treatment. The study met its primary pharmacokinetic
objective and showed statistically significant improvements in all
pre-specified secondary measures of cardiac function in the
treatment group receiving pharmacokinetic-based (PK) dose
titration.
In analyses announced today, measures of
efficacy of omecamtiv mecarbil were compared after 20 weeks of
treatment for patients with and without AF, a subgroup whose
enrollment was limited to approximately 20 percent of the overall
study population. Between 32 patients with AF and 117 patients
without AF, there were no significant differences in the effect of
omecamtiv mecarbil on systolic ejection time (p=.69), stroke volume
(p=.38), left ventricular end-diastolic dimension (p=.90), left
ventricular end-systolic dimension (p=.75), heart rate (p=.08) and
NT-proBNP (p=.43). These results suggest that patients with both
heart failure and AF respond similarly to treatment with omecamtiv
mecarbil as patients with heart failure without AF.
About Omecamtiv Mecarbil and the Phase 3 Clinical Trials
Program
Omecamtiv mecarbil is a novel, selective cardiac
myosin activator that binds to the catalytic domain of myosin.
Preclinical research has shown that cardiac myosin activators
increase cardiac contractility without affecting intracellular
myocyte calcium concentrations or myocardial oxygen
consumption.i,ii,iii Cardiac myosin is the cytoskeletal motor
protein in the cardiac muscle cell that is directly responsible for
converting chemical energy into the mechanical force resulting in
cardiac contraction.
Omecamtiv mecarbil is being developed for the
potential treatment of heart failure with reduced ejection fraction
(HFrEF) under a collaboration between Amgen and Cytokinetics, with
funding and strategic support from Servier. Omecamtiv mecarbil is
the subject of a comprehensive Phase 3 clinical trials program
comprised of GALACTIC-HF (Global
Approach to Lowering
Adverse Cardiac Outcomes
Through Improving
Contractility in Heart
Failure), a large, Phase 3 global cardiovascular
outcomes trial being conducted by Amgen in collaboration with
Cytokinetics and METEORIC-HF (Multicenter
Exercise Tolerance
Evaluation of Omecamtiv Mecarbil
Related to Increased
Contractility in Heart
Failure), a Phase 3 clinical trial designed to
evaluate the effect of treatment with omecamtiv mecarbil on
exercise capacity, being conducted by Cytokinetics in collaboration
with Amgen.
About Cytokinetics
Cytokinetics is a late-stage
biopharmaceutical company focused on discovering, developing and
commercializing first-in-class muscle activators and best-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 collaborating
with Amgen Inc. (Amgen) to develop omecamtiv
mecarbil, a novel cardiac muscle activator. Omecamtiv
mecarbil is the subject of an international clinical trials
program in patients with heart failure including GALACTIC-HF and
METEORIC-HF. Amgen holds an exclusive worldwide license
to develop and commercialize omecamtiv mecarbil with a
sublicense held by Servier for commercialization
in Europe and certain other
countries. Cytokinetics is collaborating
with Astellas Pharma Inc. (Astellas) to
develop reldesemtiv, a fast skeletal muscle troponin activator
(FSTA). Reldesemtiv was the subject of a Phase 2
clinical study in patients with spinal muscular atrophy which
showed increases in measures of endurance and stamina consistent
with the mechanism of action. Reldesemtiv is currently
the subject of a Phase 2 clinical trial in patients with
amyotrophic lateral sclerosis. Astellas holds an exclusive
worldwide license to develop and commercialize reldesemtiv.
Licenses held by Amgen and Astellas are subject to
specified co-development and co-commercialization rights
of Cytokinetics. Cytokinetics is also developing
CK-274, a novel cardiac myosin inhibitor that company scientists
discovered independent of its collaborations, for the potential
treatment of hypertrophic cardiomyopathies.
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 Cytokinetics’ and its partners’
research and development activities; the design, results,
significance and utility of preclinical study 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,
including risks that current and past results of clinical trials or
preclinical studies may not be indicative of future clinical trial
results, 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; Cytokinetics may incur
unanticipated research and development and other costs or be unable
to obtain additional financing necessary to conduct development of
its products; 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:CytokineticsDiane
WeiserVice President, Corporate Communications, Investor
Relations(415) 290-7757
___________________________
i Planelles-Herrero VJ, Hartman JJ, Robert-Paganin J. et al.
Mechanistic and structural basis for activation of cardiac myosin
force production by omecamtiv mecarbil. Nat Commun. 2017;8:190.
ii Shen YT, Malik FI, Zhao X, et al. Improvement of cardiac
function by a cardiac myosin activator in conscious dogs with
systolic heart failure. Circ Heart Fail. 2010; 3: 522-27.
iii Malik FI, Hartman JJ, Elias KA, Morgan BP, Rodriguez H,
Brejc K, Anderson RL, Sueoka SH, Lee KH, Finer JT, Sakowicz R.
Cardiac myosin activation: a potential therapeutic approach for
systolic heart failure. Science. 2011 Mar
18;331(6023):1439-43.
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