Cytokinetics Announces Start of Phase 2 Clinical Trial of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure
April 04 2016 - 7:30AM
Cytokinetics, Inc. (Nasdaq:CYTK) today announced the start of a
double-blind, randomized, placebo-controlled, multi-center Phase 2
clinical trial to evaluate the safety, pharmacokinetics and
efficacy of omecamtiv mecarbil in Japanese subjects with heart
failure and reduced ejection fraction. 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.
“Advancing the clinical investigation of
omecamtiv mecarbil in Japan represents an important step for our
novel cardiac myosin activator program,” said Fady I. Malik, MD,
PhD, Cytokinetics' Executive Vice President, Research and
Development. “Omecamtiv mecarbil holds promise as a potential new
treatment for patients with heart failure and we look forward to
learning about its clinical application in Japanese patients.”
Phase 2 Clinical Trial
Design
The ongoing Phase 2 clinical trial of omecamtiv
mecarbil in Japan will evaluate approximately 80 subjects with
chronic stable heart failure with reduced ejection fraction over 16
weeks randomized 1:1:1:1 to receive either placebo or omecamtiv
mecarbil twice daily at 25 mg, 37.5 mg or 50 mg. Subjects
randomized to 37.5 mg or 50 mg will be up-titrated using a
PK-guided dose titration strategy. The primary objectives of the
trial are to assess the pharmacokinetics, safety, and tolerability
of omecamtiv mecarbil in Japanese subjects with heart failure and
reduced ejection fraction. The secondary objective is to measure
changes from baseline in systolic ejection time measured at week
16. Additional information can be found at clinicaltrials.gov.
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. Les Laboratoires Servier obtained an
exclusive option to commercialize omecamtiv mecarbil in Europe.
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. Cytokinetics is collaborating with Amgen Inc. to
develop omecamtiv mecarbil, a novel cardiac muscle activator, for
the potential treatment of heart failure. Cytokinetics is
collaborating with Astellas Pharma Inc. to develop CK-2127107, a
fast skeletal muscle activator, for the potential treatment of
spinal muscular atrophy. 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, plans and timing of the ongoing Phase 2 clinical trial
of omecamtiv mecarbil and a potential Phase 3 clinical trial of
omecamtiv mecarbil; the potential for eventual regulatory approval,
commercialization and launch of Cytokinetics’ product candidates;
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 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, and Cytokinetics may
be unable to obtain or maintain patent or trade secret protection
for its intellectual property; and 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; 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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