Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that
results from FORTITUDE-ALS
(
Functional
Outcomes in
a
Randomized
Trial
of
Investigational
Treatment
with CK-2127107
to
Understand
Decline
in
Endpoints – in
ALS),
the Phase 2 clinical trial of reldesemtiv in patients with
amyotrophic lateral sclerosis (ALS), will be presented in a
platform presentation at the American Academy of Neurology 71st
Annual Meeting in Philadelphia on Sunday, May 5, 2019.
FORTITUDE-ALS is designed to assess the change
from baseline in the percent predicted slow vital capacity (SVC)
and other measures of skeletal muscle function after 12 weeks of
treatment with reldesemtiv (formerly CK-2127107). In collaboration
with Astellas Pharma Inc.
(Astellas), Cytokinetics is developing reldesemtiv,
a next-generation fast skeletal muscle troponin activator (FSTA),
as a potential treatment for people living with debilitating
diseases and conditions associated with skeletal muscle weakness
and/or fatigue.
Title: Update of FORTITUDE-ALS:
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study to
Evaluate Efficacy, Safety and Tolerability of Reldesemtiv in
Patients with Amyotrophic Lateral
SclerosisSpeaker: Jeremy Shefner, M.D., Ph.D.,
Lead Investigator of FORTITUDE-ALS, Professor and Chair of
Neurology at Barrow Neurological Institute, and Professor and
Executive Chair of Neurology at University of Arizona,
PhoenixSession: S5: Therapeutics in ALS and
SMADate: Sunday, May 5, 2019Presentation
Time: 1:11 PM – 1:22 PM ESTLocation:
Pennsylvania Convention Center, Philadelphia
“Fast skeletal troponin activation may offer a
new approach to treating ALS, a disease for which there are still
few therapies for patients,” said Fady Malik, M.D., Ph.D.,
Cytokinetics’ Executive Vice President of Research and Development.
“We look forward to sharing results from this trial with the ALS
community as may inform our potential further development of
reldesemtiv in ALS.”
About FORTITUDE-ALS
FORTITUDE-ALS is a Phase 2, double-blind,
randomized, placebo-controlled, parallel group, dose ranging trial
of reldesemtiv in patients with ALS. Over 450 eligible
ALS patients from centers in the U.S., Canada, Europe
and Australia were randomized (1:1:1:1) to receive either
150 mg, 300 mg or 450 mg of reldesemtiv dosed orally
twice daily or placebo for 12 weeks. The primary efficacy endpoint
is the change from baseline in the percent predicted SVC at 12
weeks. Secondary endpoints include slope of the change from
baseline in the mega-score of muscle strength measured by hand held
dynamometry (HHD) and handgrip dynamometry in patients
on reldesemtiv; change from baseline in the ALS
Functional Rating Scale – Revised (ALSFRS-R); incidence and
severity of treatment-emergent adverse events (TEAEs); and plasma
concentrations of reldesemtiv at the sampled time points
during the trial.
In addition, exploratory endpoints are being
measured including the effect of reldesemtiv versus
placebo on self-assessments of respiratory function made at home by
the patient with help as needed by the caregiver; disease
progression through quantitative measurement of speech production
characteristics over time; disease progression through quantitative
measurement of handwriting abilities over time; and change from
baseline in quality of life (as measured by the ALSAQ-5) in
patients on reldesemtiv.
About ALS
Amyotrophic lateral sclerosis (ALS) is a
progressive neurodegenerative disease that afflicts approximately
20,000 people in the United States and a comparable number of
patients in Europe. Approximately 5,000 new cases of ALS are
diagnosed each year in the United States. The average life
expectancy of an ALS patient is approximately three to five years
after diagnosis and only approximately 10 percent of patients
survive for more than 10 years. Death is usually due to respiratory
failure because of diminished strength in the skeletal muscles
responsible for breathing. Few treatment options exist for these
patients, resulting in a high unmet need for new therapies to
address functional deficits and disease progression.
About Reldesemtiv
Skeletal muscle contractility is driven by the
sarcomere, the fundamental unit of skeletal muscle contraction and
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. Reldesemtiv, a next-generation fast skeletal muscle
troponin activator (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. Reldesemtiv has demonstrated
pharmacological activity that may lead to new therapeutic options
for diseases associated with muscle weakness and fatigue. In
non-clinical models of SMA, a skeletal muscle activator has
demonstrated increases in submaximal skeletal muscle force and
power in response to neuronal input and delays in the onset and
reductions in the degree of muscle
fatigue. Reldesemtiv 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 2 clinical trial in patients with
ALS, reldesemtiv was the subject of a Phase 2 clinical study
in patients with spinal muscular atrophy which showed increases in
measures of endurance and stamina consistent with the mechanism of
action.
About Cytokinetics and
Astellas Collaboration
In 2013, Astellas
and Cytokinetics formed a partnership focused 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. Under the
collaboration, Cytokinetics exclusively licensed to
Astellas rights to co-develop and potentially
co-commercialize reldesemtiv, a fast skeletal muscle troponin
activator (FSTA), in non-neuromuscular indications. In 2014,
Astellas and Cytokinetics agreed to expand the
collaboration to include certain neuromuscular indications,
including SMA, and to advance reldesemtiv into Phase 2
clinical development, initially in SMA. Under the agreement as
further amended in 2016, Astellas has exclusive rights to
co-develop and commercialize reldesemtiv 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 and best-in-class
muscle inhibitors 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 impact muscle function and
contractility. Cytokinetics is collaborating
with Amgen Inc. (Amgen) to develop omecamtiv
mecarbil, a novel cardiac muscle activator. Omecamtiv
mecarbil is the subject of an international clinical trials
program in patients with heart failure including GALACTIC-HF and
METEORIC-HF. 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.
Cytokinetics is collaborating with Astellas Pharma
Inc. (Astellas) to develop reldesemtiv, a fast skeletal
muscle troponin activator (FSTA). Reldesemtiv has been
granted orphan drug designation by the FDA for the
potential treatment of spinal muscular
atrophy. Reldesemtiv was the subject of a Phase 2
clinical study in patients with spinal muscular atrophy which
showed increases in measures of endurance and stamina consistent
with the mechanism of action. Reldesemtiv is currently
the subject of a Phase 2 clinical trial in patients with
amyotrophic lateral sclerosis. Astellas holds an exclusive
worldwide license to develop and commercialize reldesemtiv.
Licenses held by Amgen and Astellas are subject to
specified co-development and co-commercialization rights
of Cytokinetics. Cytokinetics is also developing CK-274,
a novel cardiac myosin inhibitor that company scientists discovered
independent of its collaborations, for the potential treatment of
hypertrophic cardiomyopathies. Cytokinetics continues its over
20-year history of pioneering innovation in muscle biology and
related pharmacology focused to diseases of muscle dysfunction and
conditions of muscle weakness.
For additional information
about Cytokinetics, visit www.cytokinetics.com and follow
us on Twitter, LinkedIn, Facebook and YouTube.
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 Phase 2 clinical
study of reldesemtiv in patients with SMA and its
potentially beneficial effects; 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; Astellas’
decisions with respect to the design, initiation, conduct, timing
and continuation of development activities
for reldesemtiv; 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; 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:CytokineticsDiane
WeiserVice President, Corporate Communications, Investor
Relations(415) 290-7757
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