Cytokinetics Announces Additional Results From COSMIC-HF at the American Heart Association Scientific Sessions 2017
November 13 2017 - 2:10PM
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 clinical trial evaluating omecamtiv mecarbil in
patients with chronic heart failure and left ventricular systolic
dysfunction, were presented by John Teerlink, M.D. in an Abstract
Rapid Fire Oral presentation at the American Heart Association
Scientific Sessions 2017 in Anaheim, Calif. Dr. Teerlink is
Professor of Clinical Medicine at the University of California San
Francisco and Director of Heart Failure at the San Francisco
Veterans Affairs Medical Center. In this post-hoc responder
analysis, the proportion of patients achieving various thresholds
in the percent reduction of NT-proBNP were larger in patients who
received omecamtiv mecarbil than in patients who received
placebo. 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.
“NT-proBNP is a biomarker of ventricular wall
stress, with higher levels reflecting more severe heart failure,”
said Fady I. Malik, MD, PhD, Cytokinetics’ Executive Vice President
of Research & Development. “This analysis showed that omecamtiv
mecarbil reduces NT-proBNP in a potentially meaningful way,
consistent with a reduction in ventricular wall stress. With these
positive changes observed for NT-proBNP and other measures relevant
to heart failure in COSMIC-HF, we now look forward in GALACTIC-HF
to learning if omecamtiv mecarbil can improve clinical outcomes in
patients with heart failure.”
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 trial 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.
This post-hoc responder analysis evaluated
percent changes in NT-proBNP between patients receiving placebo or
omecamtiv mecarbil from baseline to week 20 in the PK titration
group of COSMIC-HF. Responders were defined as those patients who
achieved various thresholds in the percent reduction of NT-proBNP
from baseline to 20 weeks. The percentage of patients receiving
omecamtiv mecarbil and meeting each responder definition was
compared to the corresponding percentage of patients in the placebo
group meeting the same responder definition. In patients receiving
omecamtiv mecarbil compared to placebo, there was a statistically
significant greater proportion of responders at each threshold
except for that evaluating a > 50 percent decrease from
baseline.
Percent decrease inNT‑proBNP frombaseline to 20
weeks |
Proportion of Responders |
Omecamtiv Mecarbil |
Placebo |
p value |
> 20% |
48 |
% |
36 |
% |
0.047 |
> 30% |
42 |
% |
30 |
% |
0.047 |
> 40% |
33 |
% |
21 |
% |
0.039 |
> 50% |
20 |
% |
15 |
% |
>0.05 |
The data from this post-hoc analysis suggest
omecamtiv mecarbil reduced myocardial wall stress, perhaps
providing a mechanism for beneficial ventricular reverse
remodeling, which is a reversal of the ventricular enlargement that
occurs in patients with systolic heart failure, that may translate
into clinically meaningful effects on cardiovascular outcomes.
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 in the
United States. Despite broad use of standard treatments and
advances in care, the prognosis for patients with heart failure is
poor. In the United States, 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 muscle 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 (FDA) and orphan medicinal product designation
by the European Medicines Agency for the potential
treatment of ALS. Cytokinetics is preparing for the
potential commercialization of tirasemtiv in North
America and Europe and has granted an option
to Astellas Pharma Inc. (“Astellas”) for development and
commercialization in other countries. Cytokinetics is
collaborating with Astellas to develop CK-2127107, a
next-generation FSTA. CK-2127107 has been granted orphan drug
designation by the FDA for the potential treatment of
SMA. CK-2127107 is the subject of three ongoing Phase 2 clinical
trials enrolling patients with spinal muscular atrophy, chronic
obstructive pulmonary disease and ALS. Astellas is also conducting
a Phase 1b clinical trial of CK-2127107 in elderly adults with
limited mobility. Cytokinetics is collaborating
with Amgen Inc. (“Amgen”) to develop omecamtiv
mecarbil, a novel cardiac myosin 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, the properties and potential benefits of
Cytokinetics’ drug candidates, including omecamtiv mecarbil;
the design, timing, results and significance of GALACTIC-HF, the
Phase 3 clinical trial of omecamtiv mecarbil in subjects
with chronic heart failure and reduced ejection fraction; and the
potential for eventual regulatory approval, commercialization and
launch of Cytokinetics’ product 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 current and past results of
clinical trials or preclinical studies may not be indicative of
future clinical trials 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 U.S. Food
and Drug Administration or foreign regulatory agencies may
delay or limit Cytokinetics' or its partners' ability to
conduct clinical trials; 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.
Contact:CytokineticsDiane
WeiserVice President, Corporate Communications, Investor
Relations(415) 290-7757
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