Cytokinetics Announces Additional Results From COSMIC-HF Presented at ACC.17
March 20 2017 - 7:30AM
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, were presented by Tor Biering-Sørensen, MD, PhD,
Postdoctoral Research Fellow, Division of Cardiology, Brigham &
Women’s Hospital and Harvard Medical School, in a Poster Session at
the American College of Cardiology’s 66th Annual Scientific Session
(ACC.17) in Washington, D.C. The results presented showed that
omecamtiv mecarbil improved myocardial deformation, a marker of
myocardial function that has been related to outcomes. 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 results provide the first, direct
echocardiographic evidence in humans that increases in the
contractility of cardiac muscle underlie the improvements in
overall cardiac function observed in COSMIC-HF,” 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 left ventricular
(LV) myocardial deformation, including global circumferential
strain (GCS) and mean global longitudinal strain (GLS), were
compared at baseline and at 20 weeks of treatment in the placebo
group, the 25 mg twice daily group, and the PK-guided dose
titration group. At 20 weeks, both mean GLS and GCS improved in the
25 mg twice daily group (p=0.014, p=0.001, respectively), and
showed a trend towards improvement in the PK-guided dose titration
group (p=0.06, p=0.13, respectively). These results further support
that omecamtiv mecarbil directly improves myocardial contractile
function.
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 also entered an alliance with
Servier for exclusive commercialization rights in Europe as well as
the Commonwealth of Independent States, including Russia. Servier
contributes funding for development and provides strategic support
to the program.
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 troponin activator
(FSTA). Tirasemtiv is the subject of
VITALITY-ALS, an international Phase 3 clinical trial in
patients with 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. Cytokinetics is
preparing for the potential commercialization
of tirasemtiv in North
America and Europe and has granted an option
to Astellas Pharma Inc. for development and
commercialization in other countries. Cytokinetics is
collaborating with Astellas to develop CK-2127107, a
next-generation fast skeletal muscle activator. CK-2127107 is
the subject of two ongoing Phase 2 clinical trials enrolling
patients with spinal muscular atrophy and chronic obstructive
pulmonary disease. Cytokinetics is collaborating
with Amgen Inc. to develop omecamtiv mecarbil, a
novel cardiac muscle activator. Omecamtiv
mecarbil is the subject of GALACTIC-HF, an international Phase
3 clinical trial in patients with heart
failure. 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. Astellas
holds an exclusive worldwide license to develop and commercialize
CK-2127107. Licenses held by Amgen and Astellas are
subject to Cytokinetics' specified co-development and
co-commercialization 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
design, results, significance and utility of COSMIC-HF clinical
trial results and the potential for success and timing for the
progression of omecamtiv mecarbil; 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.
Contact:
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3060
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