Cytokinetics Announces Start of Phase 2 Clinical Trial of CK-2127107 in Patients With Chronic Obstructive Pulmonary Disease
June 30 2016 - 7:30AM
Cytokinetics, Inc. (Nasdaq:CYTK) today announced the start of a
randomized, double-blind, placebo-controlled, two period crossover
clinical trial designed to assess the effect of CK-2127107 (CK-107)
on physical function in patients with chronic obstructive pulmonary
disease (COPD). CK-107 is a novel fast skeletal muscle troponin
activator which is being developed as a potential treatment for
people living with SMA, COPD and certain other debilitating
diseases and conditions associated with muscular weakness and/or
fatigue. Astellas is conducting this Phase 2 clinical trial
in collaboration with Cytokinetics.
“Patients with COPD suffer from significant
exercise intolerance due to metabolic abnormalities that produce
weakness in limb muscles, as well as an associated switch from slow
to fast muscle fiber predominance,” said Fady I. Malik,
Cytokinetics’ Executive Vice President and Head of Research &
Development. “Given CK-107’s selectivity for fast skeletal muscle
fibers, we are enthusiastic about exploring this novel therapeutic
strategy in this patient population.”
Phase 2 Clinical Trial
Design
The trial is expected to enroll approximately 40
patients with COPD in the United States and is designed to assess
the effect of CK-107 compared to placebo on exercise tolerance.
Additionally, the trial will assess cardiopulmonary and
neuromuscular effects of CK-107 relative to placebo and the effect
of CK-107 on resting spirometry relative to placebo. In
addition, the safety, tolerability and pharmacokinetics of CK-107
will be assessed. Additional information on the trial can be
found at clinicaltrials.gov.
About COPD
COPD is a progressive obstructive lung disease
that typically includes emphysema and chronic bronchitis. The
disease is increasingly common and is the third leading cause of
death in the U.S. behind cancer and heart disease. While it is
estimated that more than 14 million U.S. adults have been diagnosed
with COPD, it is widely underdiagnosed and up to 24 million
Americans have evidence of impaired lung function. Current
estimates suggest that COPD costs the nation almost $50 billion
annually in both direct and indirect health expenditures.
Therapeutic strategies for the treatment of COPD have primarily
focused to improving lung function and addressing airflow
limitations caused by bronchial obstructions. A substantial
unmet need exists for disease management strategies related to
improved exercise tolerance.
About CK-2127107
In preclinical studies, CK-107 has been shown to
slow the rate of calcium release from the regulatory troponin
complex of fast skeletal muscle fibers, thus increasing the
sensitivity of the skeletal muscle to calcium, which results in an
increase in skeletal muscle force production in response to
neuronal input and which also delays the onset and reduces the
magnitude of fatigue during repetitive muscle stimulation. Thus,
CK-107 may improve muscle function and physical performance in
people with COPD. In collaboration with Astellas,
Cytokinetics is conducting a Phase 2 clinical trial of CK-107 which
is designed to assess the effect of CK-107 on measures of muscle
function in both ambulatory and non-ambulatory patients with SMA, a
severe, genetic neuromuscular disease that leads to debilitating
muscle function and progressive, often fatal, muscle weakness.
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 and chronic obstructive pulmonary disease.
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 conduct, design,
enrollment and progress of the Phase 2 clinical trial of CK-2127107
in patients with SMA; the significance and utility of preclinical
study and clinical trial results; and the properties and potential
efficacy and safety profile of CK-2127107 and Cytokinetics' other
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,
further clinical development of tirasemtiv in ALS patients will
require significant additional funding, and Cytokinetics may
be unable to obtain such additional funding on acceptable terms, if
at all; the FDA and/or other regulatory authorities may not accept
effects on slow vital capacity as a clinical endpoint to support
registration of tirasemtiv for the treatment of ALS; 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 trial
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; Amgen's and Astellas' decisions with respect to the
design, initiation, conduct, timing and continuation of development
activities for omecamtiv mecarbil and CK-107, respectively;
Cytokinetics may incur unanticipated research and development and
other costs or be unable to obtain additional financing necessary
to conduct development of its products; Cytokinetics may be unable
to enter into future collaboration agreements for its drug
candidates and programs on acceptable terms, if at all; 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; and risks
and uncertainties relating to the timing and receipt of payments
from its partners, including milestones and royalties on future
potential product sales under Cytokinetics' collaboration
agreements with such partners. 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
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Apr 2023 to Apr 2024