Cytokinetics Announces Start of GALACTIC-HF, a Phase 3 Clinical Trial of Omecamtiv Mecarbil
December 01 2016 - 7:30AM
Trial to be Conducted Under Special
Protocol Assessment with the FDA
Cytokinetics, Inc. (Nasdaq:CYTK) today announced the activation of
the first clinical site and the start of GALACTIC-HF
(
Global
Approach to
Lowering
Adverse
Cardiac Outcomes
Through
Improving
Contractility in
Heart
Failure), the Phase 3
cardiovascular outcomes clinical trial of omecamtiv mecarbil which
is being conducted by Amgen, in collaboration with Cytokinetics.
Coincident with the start of the trial, Amgen will make a $26.7
million milestone payment to Cytokinetics. In clinical studies,
omecamtiv mecarbil, a novel investigational cardiac myosin
activator, has been shown to enhance cardiac function by increasing
cardiac contractility and is being developed for the potential
treatment of patients with chronic heart failure.
The primary objective of this double-blind,
randomized, placebo-controlled multicenter clinical trial is 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 will be conducted under a Special
Protocol Assessment (SPA) with the U.S. FDA.
“We are pleased that GALACTIC-HF is underway and
we are grateful for the participation of investigators and their
staff at the many hundreds of clinical sites worldwide who will be
managing the care of the chronic heart failure patients in this
pivotal trial,” said Robert I. Blum, Cytokinetics’ President and
Chief Executive Officer. “We will look forward to the results of
this Phase 3 trial which is designed to assess whether the
increases in cardiac function observed in prior trials of omecamtiv
mecarbil will translate into improved cardiovascular outcomes for
patients living with chronic heart failure.”
GALACTIC-HF: Trial Design
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. In order to be eligible to participate in GALACTIC-HF
patients should have an LVEF ≤ 35%, be NYHA class II to IV, and
have an elevated BNP or NT-proBNP. Patients will be randomized to
either placebo or omecamtiv mecarbil with dose titration up to a
maximum dose of 50 mg twice daily based on the plasma concentration
of omecamtiv mecarbil after initiation of drug therapy. The primary
endpoint is a composite of time to cardiovascular death or first
heart failure event, which is defined as either a hospitalization
for heart failure or other urgent treatment for worsening heart
failure. Secondary endpoints include time to cardiovascular death;
patient reported outcomes as measured by the Kansas City
Cardiomyopathy Questionnaire Total Symptom Score; time to first
heart failure hospitalization; and all-cause death. For additional
information, please visit http://bit.ly/2fC2wtp.
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. Amgen has granted a sublicense to Servier
to commercialize omecamtiv mecarbil in Europe, as well as the
Commonwealth of Independent States, including Russia.
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 design, results,
significance and utility of GALACTIC-HF clinical trial results and
the likelihood and timing for the progression of omecamtiv
mecarbil; and the properties and potential benefits of
Cytokinetics' drug candidates; and Cytokinetics’ receipt of
milestone payments from Amgen, including the timing of such
payments. 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.
Contact:
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757
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