Cytokinetics Announces Positive Results From Phase 2 Clinical Trial of Omecamtiv Mecarbil in Japanese Patients With Heart Fai...
August 02 2017 - 7:30AM
Data Supports Inclusion of Japan in
GALACTIC-HF
Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that the
Phase 2 clinical trial of omecamtiv mecarbil in Japanese patients
with heart failure has met its pharmacokinetic primary endpoint and
demonstrated statistically significant improvements in systolic
ejection time (SET), a secondary endpoint. 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.
“We are pleased that this Phase 2 trial of
omecamtiv mecarbil met its objectives in this population of
Japanese heart failure patients,” said Fady I. Malik, MD, PhD,
Cytokinetics' Executive Vice President, Research and Development.
“The pharmacokinetics, pharmacodynamics, safety, and tolerability
data from this trial were consistent with previously reported
results from COSMIC-HF. We are now collaborating with Amgen on
start-up activities for Japanese sites to participate in
GALACTIC-HF.”
Cytokinetics is eligible to earn a $10 million
milestone payment from Amgen upon the first dosing of a patient in
Japan in GALACTIC-HF, the ongoing Phase 3 cardiovascular clinical
outcomes trial of omecamtiv mecarbil.
Design of Phase 2 Clinical Trial in Japan
This Phase 2 clinical trial in Japanese patients
with heart failure was designed to assess the pharmacokinetics of
omecamtiv mecarbil as well as its effect on cardiac function,
safety and tolerability in Japanese patients with chronic heart
failure. The trial randomized 81 patients 1:1:1:1 to placebo, 25 mg
of omecamtiv mecarbil twice daily and two separate PK-based
titration groups in which the dose of omecamtiv mecarbil could be
increased from 25 to 37.5 mg or 50 mg twice daily based on the
pre-dose concentration of omecamtiv mecarbil at week 2. Patients
received study drug for 16 weeks after randomization. The primary
endpoint was to assess the plasma concentrations of omecamtiv
mecarbil at weeks 2, 4, 12 and 16, and the area under the curve
(AUC) at week 8. The secondary endpoint was to assess the change
from baseline in SET measured by echocardiography at week 16.
About GALACTIC-HF
GALACTIC-HF (Global
Approach to Lowering
Adverse Cardiac Outcomes
Through Improving
Contractility in Heart
Failure) is a Phase 3, double-blind, randomized,
placebo-controlled multicenter clinical trial designed to determine
if treatment with omecamtiv mecarbil when added to standard of care
is superior to standard of care plus placebo in reducing the risk
of cardiovascular death or heart failure events in patients with
high risk chronic heart failure and reduced ejection fraction.
GALACTIC-HF is planned to enroll approximately 8,000 symptomatic
chronic heart failure patients in over 800 sites in 34 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.
GALACTIC-HF is being conducted under a Special Protocol Assessment
(SPA) with the U.S. FDA.
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 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, the properties and potential benefits of Cytokinetics’
drug candidates, including omecamtiv mecarbil; the design, timing,
results and significance of the Phase 2 clinical trial of omecamtiv
mecarbil in Japanese subjects with chronic heart failure and
reduced ejection fraction and GALACTIC-HF; Cytokinetics’ and
Amgen’s collaboration on start-up activities for Japanese sites to
participate in GALACTIC-HF; Cytokinetics’ eligibility to receive a
milestone payment from Amgen; 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:
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757
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