Cytokinetics Announces Start of Phase 1b Clinical Trial of CK-2127107 in Elderly Subjects With Limited Mobility
June 29 2017 - 7:30AM
Cytokinetics, Incorporated (Nasdaq:CYTK) today announced the start
of a Phase 1b, double-blind, randomized, placebo-controlled,
multiple dose, two-period crossover study to assess the effect of
CK-2127107 on measures of physical function in elderly adults with
limited mobility. CK-2127107 is a next-generation fast skeletal
muscle troponin activator (FSTA) which is being developed as a
potential treatment for people living with spinal muscular atrophy
(SMA), chronic obstructive pulmonary disease (COPD) and certain
other debilitating diseases and conditions associated with muscular
weakness and/or fatigue. Astellas is conducting this Phase 1b
clinical trial in collaboration with Cytokinetics.
“Maintaining muscle strength and mobility is
essential for older adults to sustain their independence and
minimize the risk of disability,” said Fady I. Malik, Cytokinetics’
Executive Vice President, Research & Development. “We look
forward to data from this trial which will investigate the
potential for CK-2127107 to increase skeletal muscle force and
reduce muscle fatigue in frail subjects, representative of the
growing population of aging baby boomers.”
Phase 1b Clinical Trial
Design
The clinical trial is expected to enroll at
least 60 subjects in the United States who are 70 to 89 years of
age with limited mobility. Patients will be randomized to one of
two treatment sequences in a 1:1 ratio to receive both CK-2127107
and placebo over two 14-day treatment periods, separated by a
14-day washout period. During treatment periods, patients will
receive 500 mg of CK-2127107 or placebo twice daily, except on days
1 and 14, when they receive 500 mg of CK-2127107 once daily. The
total study duration including the screening period and follow-up
visit will be approximately 12 weeks. The trial is designed to
assess the effect of CK-2127107 on skeletal muscle fatigue assessed
as change from baseline versus 14 days of treatment in sum of peak
torque during isokinetic knee extensions. Additionally, the trial
will assess the effects of CK-2127107 on physical performance via a
short physical performance battery, stair-climb test and 6-minute
walk test. In addition, the safety, tolerability and
pharmacokinetics of CK-2127107 will be assessed. Additional
information on the trial can be found at clinicaltrials.gov.
About CK-2127107
Skeletal muscle contractility is driven by the
sarcomere, the fundamental unit of skeletal muscle contraction. It
is a highly ordered cytoskeletal structure composed of several key
proteins. Skeletal muscle myosin is the motor protein that converts
chemical energy into mechanical force through its interaction with
actin. A set of regulatory proteins, which includes tropomyosin and
several types of troponin, make the actin-myosin interaction
dependent on changes in intracellular calcium levels. CK-2127107, a
next-generation FSTA arising from Cytokinetics' skeletal muscle
contractility program, slows the rate of calcium release from the
regulatory troponin complex of fast skeletal muscle fibers, which
sensitizes the sarcomere to calcium, leading to an increase in
skeletal muscle contractility. CK-2127107 has demonstrated
pharmacological activity that may lead to new therapeutic options
for diseases associated with muscle weakness and fatigue.
CK-2127107 has been granted orphan drug designation by the U.S.
Food and Drug Administration (FDA) for the potential treatment of
SMA. CK-2127107 has been the subject of five completed Phase 1
clinical trials in healthy volunteers, which evaluated the safety,
tolerability, bioavailability, pharmacokinetics and
pharmacodynamics of the drug candidate. In addition to the Phase 1b
clinical trial, CK-2127107 is the subject of Phase 2 clinical
trials in patients with SMA and patients with COPD. An additional
Phase 2 clinical trial is planned in patients with ALS for later
this year.
About Limited Mobility in Elderly
Adults
People over the age of 65 represent the fastest
growing segment of the U.S. population and up to 25 percent of
older adults experience limitations in mobility. Older
persons who lose mobility are less likely to socialize in their
communities, have higher rates of morbidity, mortality and
hospitalizations and may experience compromised quality of life.
Mobility limitations are associated with increased healthcare
costs. On average, older adults unable to walk a quarter mile incur
$4,000 more per year in health care costs compared to their peers
without limited mobility.
About the Cytokinetics and Astellas
Collaboration
Cytokinetics and Astellas collaborate on the
research, development, and commercialization of skeletal muscle
activators. The primary objective of the collaboration is to
advance novel therapies for diseases and medical conditions
associated with muscle impairment and weakness. Cytokinetics has
licensed to Astellas exclusive rights to co-develop and
commercialize CK-2127107 and other FSTAs in non-neuromuscular
indications and certain neuromuscular indications (including SMA
and ALS) and other novel mechanism skeletal muscle activators in
all indications, subject to certain Cytokinetics’ development and
commercialization rights; Cytokinetics may co-promote and conduct
certain commercial activities in North America and Europe under
agreed scenarios.
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 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 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 treatment of spinal muscular atrophy (SMA). CK-2127107 is the
subject of two ongoing Phase 2 clinical trials enrolling patients
with SMA and patients with COPD. Astellas holds an exclusive
worldwide license to develop and commercialize CK-2127107.
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. 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, statements relating to Cytokinetics’ and its partners’
research and development activities; the design, timing, results
and significance of clinical trials, including Cytokinetics’ Phase
1b clinical trial of CK-2127107 on measures of physical function in
elderly adults with limited mobility; 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; 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 CK-2127107; 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.
Contact:
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757
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