Cytokinetics Announces Presentation of Additional Results From COSMIC-HF at the AHA Annual Scientific Meeting
November 14 2016 - 4:00PM
Data Show Omecamtiv Mecarbil Improved
Measures of Left Atrial Structure and Function
Cytokinetics, Inc. (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 and left ventricular systolic dysfunction, were presented
by Tor Biering-Sørensen, Division of Cardiology, Brigham &
Women’s Hospital and Harvard Medical School, in a Clinical Poster
Session at the American Heart Association’s Scientific Sessions
2016 in New Orleans. The results presented show that omecamtiv
mecarbil improved left atrial (LA) structure and function in
patients with chronic heart failure with reduced systolic function.
Omecamtiv mecarbil, a novel investigational cardiac myosin
activator that increases cardiac contractility, is being developed
by Amgen in collaboration with Cytokinetics for
the potential treatment of heart failure.
“These data add to the previously reported
results from COSMIC-HF which showed improvements in left
ventricular function and volumes following treatment with omecamtiv
mecarbil and provide further evidence for the potential for this
novel mechanism drug candidate to reverse both ventricular and
atrial enlargement in patients with chronic heart failure,” said
Fady I. Malik, MD, PhD, Cytokinetics' Executive Vice
President, Research and Development.
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 this analysis, measures of LA structure and
function were obtained at baseline, week 12 and week 20 and
patients from the PK titration group were compared to the placebo
group. The analysis showed that minimum and maximum left atrial
volume (LAV) decreased over time, with a statistically significant
reduction in minimum LAV at 20 weeks (p=0.032) in patients
receiving omecamtiv mecarbil. Similarly, patients receiving
omecamtiv mecarbil experienced statistically significant
improvements in LA emptying fraction at 12 and 20 weeks (p=0.018,
p=0.004, respectively).
About Heart Failure
Heart failure is a grievous condition that
affects more than 23 million people worldwide, about half of whom
have reduced left ventricular function. It is the leading cause of
hospitalization and readmission in people age 65 and older. Despite
broad use of standard treatments and advances in care, the
prognosis for patients with heart failure is poor. An estimated one
in five people over the age of 40 are at risk of developing heart
failure, and approximately 50 percent of people diagnosed with
heart failure will die within five years of initial
hospitalization.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is a novel cardiac
myosin activator. 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. Cardiac myosin activators are thought to
accelerate the rate-limiting step of the myosin enzymatic cycle and
shift the enzymatic cycle in favor of the force-producing state.
Preclinical research has shown that cardiac myosin activators
increase contractility in the absence of changes in intracellular
calcium in cardiac myocytes.
Omecamtiv mecarbil is being developed
by Amgen in collaboration
with Cytokinetics. Amgen holds an exclusive, worldwide
license to omecamtiv mecarbil and related compounds,
subject to Cytokinetics’ specified development and
commercialization rights. Amgen has granted a sublicense to Servier
to commercialize omecamtiv mecarbil in Europe, as well as the
Commonwealth of Independent States, including Russia.
About Cytokinetics
Cytokinetics is a late-stage
biopharmaceutical company focused on discovering, developing and
commercializing first-in-class muscle activators 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 increase muscle
function and contractility. Cytokinetics’ lead drug candidate
is tirasemtiv, a fast skeletal muscle troponin activator, for
the potential treatment of ALS. Tirasemtiv has been
granted orphan drug designation and fast track status by
the U.S. Food and Drug Administration and orphan
medicinal product designation by the European Medicines
Agency for the potential treatment of
ALS. Cytokinetics retains the right to develop and
commercialize tirasemtiv, subject to an option held
by Astellas Pharma Inc. Cytokinetics is also
collaborating with Astellas to develop CK-2127107, a fast skeletal
muscle activator, for the potential treatment of spinal muscular
atrophy, chronic obstructive pulmonary disease and
ALS. Cytokinetics is collaborating with Amgen
Inc. to develop omecamtiv mecarbil, a novel cardiac
muscle activator, for the potential treatment of heart
failure. Amgen holds an exclusive license worldwide to
develop and commercialize omecamtiv mecarbil and Astellas
holds an exclusive license worldwide to develop and commercialize
CK-2127107. Both licenses are subject
to Cytokinetics' specified development and
commercialization participation rights. For additional information
about Cytokinetics, visit http://www.cytokinetics.com/.
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, including the
significance and utility of COSMIC-HF clinical trial results and
the timing for the progression of omecamtiv mecarbil to
Phase 3 development; 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 Amgen's decisions with
respect to the design, initiation, conduct, timing and continuation
of development activities for omecamtiv mecarbil; 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 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 U.S. Food
and Drug Administration 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; 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; 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. Forward-looking statements are not
guarantees of future performance, and Cytokinetics’ actual
results of operations, financial condition and liquidity, and the
development of the industry in which it operates, may differ
materially from the forward-looking statements contained in this
press release. Any forward-looking statements that
Cytokinetics makes in this press release speak only as of the
date of this press release. Cytokinetics assumes no obligation
to update its forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757
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