Cytokinetics and Amgen to Advance Omecamtiv Mecarbil to Phase 3 Clinical Development
September 01 2016 - 8:30AM
Cytokinetics, Inc. (Nasdaq:CYTK) today announced the advancement of
omecamtiv mecarbil to Phase 3 clinical development with a
cardiovascular outcomes clinical trial expected to initiate in the
fourth quarter of 2016. Omecamtiv mecarbil, a novel investigational
cardiac myosin activator, enhances cardiac function by increasing
cardiac contractility and is being developed for the potential
treatment of patients with chronic heart failure.
The decision to proceed to Phase 3 development
follows the review of results from prior clinical trials, including
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. Data from COSMIC-HF were first presented in a
Late-Breaking Clinical Trial session at the American Heart
Association Scientific Sessions 2015. COSMIC-HF met its primary
pharmacokinetic objective and demonstrated statistically
significant improvements in all pre-specified secondary measures of
cardiac function in the treatment group employing
pharmacokinetic-based dose titration. In addition, Amgen and
Cytokinetics have convened meetings with regulatory authorities to
inform plans for omecamtiv mecarbil in a Phase 3 clinical trials
program.
"Progression of omecamtiv mecarbil to Phase 3 is a
major milestone for our company as well as our collaboration with
Amgen and reflects our collective commitment to the heart failure
community,” said Robert I. Blum, Cytokinetics’ President and Chief
Executive Officer. “We are pleased that the comprehensive clinical
trials program that we have jointly conducted for omecamtiv
mecarbil has contributed data that provide a compelling rationale
to advance the development of our cardiac myosin activator to an
international outcomes trial for the potential treatment of
patients with chronic heart failure.”
The Phase 3 outcomes trial will be conducted by
Amgen in collaboration with Cytokinetics. As part of the Phase 3
clinical trials program, Cytokinetics and Amgen are also planning a
potential exercise performance/cardiac function clinical trial to
be conducted by Cytokinetics. Cytokinetics is eligible to receive
pre-commercialization and commercialization milestone payments on
omecamtiv mecarbil and royalties that escalate based on increasing
levels of annual net sales. Cytokinetics has the opportunity to
earn increased royalties by sharing certain Phase 3 development
costs. In that case, Cytokinetics could co-promote omecamtiv
mecarbil in North America and would have an agreed role in
commercialization activities.
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.
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, subject to an option held by Astellas Pharma Inc.
Cytokinetics is also collaborating with Astellas to develop
CK-2127107, a fast skeletal muscle activator, for the potential
treatment of spinal muscular atrophy, chronic obstructive pulmonary
disease and ALS. Cytokinetics is collaborating with Amgen Inc. to
develop omecamtiv mecarbil, a novel cardiac muscle activator, for
the potential treatment of heart failure. 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, statements relating to Cytokinetics’ and its partners’
research and development activities, including the significance and
utility of COSMIC-HF clinical trial results and the likelihood and
timing for the progression of omecamtiv mecarbil to Phase 3
development; 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.
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757
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