Amgen (NASDAQ: AMGN), Cytokinetics, Incorporated (NASDAQ: CYTK) and
Servier today announced that METEORIC-HF
(
Multicenter
Exercise
Tolerance
Evaluation of
Omecamtiv Mecarbil
Related to
Increased
Contractility in
Heart
Failure), the second Phase
3 clinical trial of omecamtiv mecarbil, a novel cardiac myosin
activator, is open to enrollment. Omecamtiv mecarbil is being
developed for the potential treatment of heart failure with reduced
ejection fraction (HFrEF).
METEORIC-HF is designed to evaluate the effect
of treatment with omecamtiv mecarbil compared to placebo on
exercise capacity as determined by cardiopulmonary exercise testing
(CPET) in patients with HFrEF. Cytokinetics is conducting
METEORIC-HF in collaboration with Amgen, with funding and strategic
support from Servier.
“The start of this second Phase 3 clinical trial
marks an important milestone in the expansion of our clinical
trials program for omecamtiv mecarbil, testing the hypothesis that
improving cardiac function with a drug candidate that directly
increases myocardial contractility may improve exercise capacity,”
said Fady I. Malik, M.D., Ph.D., executive vice president of
Research & Development at Cytokinetics. “Exercise intolerance,
typically manifested by shortness of breath and fatigue on
exertion, is a predominant symptom of chronic heart failure and
often the first symptom that prompts patients to seek medical care.
If positive, this clinical trial may provide key clinically
relevant evidence.”
METEORIC-HF Clinical Trial
DesignMETEORIC-HF is a Phase 3, randomized,
placebo-controlled, double-blind, parallel group, multicenter
clinical trial designed to evaluate the effect of treatment with
omecamtiv mecarbil compared to placebo on exercise capacity as
determined by cardiopulmonary exercise testing (CPET) following 20
weeks of treatment. The trial is designed to enroll approximately
270 patients with HFrEF at sites throughout the U.S., Canada and
Europe. In order to be eligible to participate in METEORIC-HF,
patients must have a left ventricular ejection fraction (LVEF) ≤35
percent, be New York Heart Association (NYHA) heart failure class
II or III and have reduced exercise capacity compared to age
matched controls. Patients will be randomized in a 2:1 fashion
to omecamtiv mecarbil, which will be started at 25 mg twice daily
and titrated to 25, 37.5 or 50 mg twice daily based on the same
PK-guided dosing regimen as is used in GALACTIC-HF, the ongoing
Phase 3 cardiovascular outcomes trial of omecamtiv mecarbil, or to
placebo. The primary endpoint is the change in peak oxygen uptake
(pVO2) on CPET from baseline to Week 20. Secondary endpoints
include the change in total workload during CPET from baseline to
Week 20 and the change in the average daily activity units measured
over a 2-week period from baseline (Week -2 to Day 1) to Week 18-20
as determined using accelerometry. Additional information about
METEORIC-HF can be found on
https://clinicaltrials.gov/ct2/show/NCT03759392.
About Omecamtiv Mecarbil and the Phase 3
Clinical Trials ProgramOmecamtiv 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.1,[2],3 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 study, and METEORIC-HF. Amgen is
conducting GALACTIC-HF in collaboration with Cytokinetics and
Servier.
GALACTIC-HF is designed to enroll approximately
8,000 patients at over 900 sites in 35 countries who are either
currently hospitalized for a primary reason of heart failure or
have had a hospitalization or admission to an emergency room for
heart failure within one year prior to screening. The trial is
designed to evaluate whether treatment with omecamtiv mecarbil,
when added to standard of care, reduces the risk of heart failure
events (heart failure hospitalization and other urgent treatment
for heart failure) and cardiovascular (CV) death in patients with
chronic heart failure with reduced ejection fraction.
Enrollment in GALACTIC-HF is nearing 90 percent
completion, with over 7,000 patients randomized to date from across
the spectrum of the NYHA classification (class II to IV).
Completion of patient enrollment in GALACTIC-HF is expected to
occur during the first half of 2019.
About Heart FailureHeart
failure is a grievous condition that affects more than 26 million
people worldwide,4,5 about half of whom have reduced left
ventricular function.6,7 It is the leading cause of hospitalization
and readmission in people age 65 and older.8,9 Despite broad use of
standard treatments and advances in care, the prognosis for
patients with heart failure is poor.10 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.11,12
About Cytokinetics and Amgen
CollaborationIn 2006, Cytokinetics and Amgen entered into
a strategic alliance to discover, develop and commercialize novel
small molecule therapeutics designed to activate the cardiac
sarcomere for the potential treatment of heart failure. Omecamtiv
mecarbil is being developed by Amgen in collaboration with
Cytokinetics, with funding and strategic support from Servier.
Amgen holds an exclusive, worldwide license to omecamtiv mecarbil
and related compounds, subject to Cytokinetics’ specified
development and commercialization rights. Cytokinetics is eligible
for pre-commercialization and commercialization milestone payments
and royalties that escalate based on increasing levels of annual
net sales of products commercialized under the agreement.
Cytokinetics has co-invested with Amgen in the Phase 3 development
program of omecamtiv mecarbil in exchange for increased royalties
from Amgen on worldwide sales of omecamtiv mecarbil outside Japan
and co-promotion rights in institutional care settings in North
America. 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
AmgenAmgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical
need and leverages its biologics manufacturing expertise to strive
for solutions that improve health outcomes and dramatically improve
people’s lives. A biotechnology pioneer since 1980, Amgen has grown
to be the world’s largest independent biotechnology company, has
reached millions of patients around the world and is developing a
pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and
follow us on www.twitter.com/amgen.
About
CytokineticsCytokinetics 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 Phase 3 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
also collaborating with Amgen to develop AMG 594, a first-in-class
cardiac troponin activator, discovered under the companies’ joint
research program. Further development of AMG 594 is subject to the
collaboration agreement between Amgen and Cytokinetics.
Cytokinetics is collaborating with Astellas Pharma
Inc. (Astellas) to develop reldesemtiv, a fast skeletal
muscle troponin activator (FSTA). Reldesemtiv has been
granted orphan drug designation by the FDA for the
potential treatment of spinal muscular atrophy. Reldesemtiv was the
subject of a positive 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. Cytokinetics is also
advancing CK-601, a next-generation FSTA into IND-enabling studies
under the collaboration with Astellas. 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 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.
About
ServierServier is an international pharmaceutical
company governed by a non-profit foundation and its headquarters
in France (Suresnes). With a strong international presence in
149 countries and a turnover of 4.152 billion euros in 2017,
Servier employs over 21,700 people worldwide. Entirely independent,
the Group reinvests 25% of its turnover (princeps drugs) in
research and development and uses all its profits for development.
Corporate growth is driven by Servier’s constant search for
innovation in five areas of excellence: cardiovascular,
immune-inflammatory and neuropsychiatric diseases, cancer and
diabetes, as well as by its activities in high-quality generic
drugs. Servier also offers eHealth solutions beyond drug
development.
More information: www.servier.com.
Follow us on Social
media:https://www.linkedin.com/company/servier/https://www.facebook.com/Servier/https://twitter.com/servier?lang=fr
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and Exchange Commission reports filed by Amgen, including its most
recent annual report on Form 10-K and any subsequent periodic
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and actual results may differ materially from those Amgen projects.
Discovery or identification of new product candidates or
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candidate or development of a new indication for an existing
product will be successful and become a commercial product.
Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
length of time that it takes for Amgen to complete clinical trials
and obtain regulatory approval for product marketing has in the
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Even when clinical trials are successful, regulatory authorities
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Cytokinetics Forward-Looking
StatementsThis 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 timing of enrollment of
patients in Cytokinetics’ and its partners’ 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’ 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; Amgen’s
decisions with respect to the design, initiation, conduct, timing
and continuation of development activities for omecamtiv mecarbil;
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: Amgen, Thousand OaksKristen Davis,
805-447-3008 (Media)Trish Hawkins, 805-447-5631 (Media) Arvind
Sood, 805-447-1060 (Investors)
CONTACT: Cytokinetics Diane Weiser, Vice
President, Corporate Communications, Investor Relations (415)
290-7757
CONTACT: Servier, media@servier.comSonia
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