Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new
results were presented at the 30th International Symposium on
ALS/MND in Perth, Australia, including additional analyses 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). Among the post-hoc analyses presented were results
of subgroup analyses describing the effect of reldesemtiv with and
without use of Radicava® (edaravone) and/or Rilutek® (riluzole) and
the interaction between quality of life and depression in the
placebo group. In collaboration with Astellas, Cytokinetics is
developing reldesemtiv, a fast skeletal muscle troponin activator
(FSTA), as a potential treatment for people with SMA and certain
other debilitating diseases and conditions associated with skeletal
muscle weakness and/or fatigue.
Effect of Reldesemtiv: Similar Whether
or Not Patients Received Edaravone and/or Riluzole
The results of FORTITUDE-ALS, presented earlier
this year at the American Academy of Neurology Annual Meeting,
showed that the trial did not achieve statistical significance for
a pre-specified dose-response relationship in the primary endpoint
of change from baseline in slow vital capacity (SVC) after 12 weeks
of dosing (p=0.11). However, patients on all dose groups of
reldesemtiv declined numerically less than patients on placebo for
SVC and ALS Functional Rating Scale-Revised (ALSFRS-R), with larger
differences emerging over time. In this post-hoc subgroup analysis
of all dose groups combined and compared to placebo, reldesemtiv
demonstrated a similar effect on SVC, ALSFRS-R and muscle strength
by hand held dynamometry (HHD) at 12 weeks whether or not patients
were being treated with edaravone and/or riluzole. The majority of
patients received riluzole alone (56.5%), 4.2% were receiving
edaravone alone, and 20.6% were receiving both.
For use and non-use of edaravone, the treatment
difference for reldesemtiv relative to placebo for ALSFRS-R was
1.25 points (p=0.06) and 0.77 points (p=0.06), respectively.
Decline in SVC was 3.07 percentage points less on reldesemtiv
versus placebo in patients using edaravone (p=0.14), and 1.21
percentage points less on reldesemtiv versus placebo in patients
not using edaravone (p=0.32). HHD declined 6.94 percentage points
less on reldesemtiv versus placebo for patients taking edaravone
(p=0.14), and 1.31 percentage points on reldesemtiv versus placebo
for patients not taking it (p=0.57).
For use and non-use of riluzole, the treatment
difference for reldesemtiv compared to placebo for ALSFRS-R was
0.86 (p=0.03) and 0.84 (p=0.28) points, respectively. Decline in
SVC was 1.64 percentage points less on reldesemtiv versus placebo
(p=0.16) and 1.81 percentage points less on reldesemtiv versus
placebo (p=0.46), respectively. Decline in HHD was 2.22 (p=0.36)
and 4.36 (p=0.27) less on reldesemtiv versus placebo,
respectively.
“The results from these subgroup analyses add to
the growing body of evidence regarding the effects of reldesemtiv
in patients with ALS,” said 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 the University of Arizona, Phoenix. “As the treatment
landscape evolves in ALS, these data demonstrate how we may be able
to further slow the decline of disease progression when adding new
mechanism therapies like reldesemtiv on top of existing treatment
regimens.”
Decline in Quality of Life Moderately
Associated with Depression in Placebo Patients
In FORTITUDE-ALS, patients completed
measurements of quality of life (QoL) and depression at screening,
Day 1, Weeks 2, 4, 8, 12, and at follow-up, 4 weeks after the last
dose of double-blind study drug. Patients completed the ALSAQ-5, a
QoL instrument heavily weighted to function, which asks about the
difficulty of standing, using arms, eating, speaking, and the
feeling of hopelessness about the future, where higher scores
represent worse QoL. Patients also completed the Beck Depression
Inventory Fast Screen (BDI-FS), a scale in which patients choose
the most accurate of four statements for seven topics including
hopelessness and suicidal thoughts, where higher scores represent
worsening depression. Results from 115 placebo patients were
analyzed. Mean ALSAQ-5 and BDI-FS scores increased over time and
were moderately correlated over time with an overall Spearman
correlation coefficient of 0.54 (p < 0.0001), suggesting that as
QoL declines in patients with ALS, depression worsens. Age, sex and
site of onset were not related to change in depression, but
depression scores increased at a slower pace in placebo patients
using edaravone.
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 Cytokinetics and Astellas
Collaboration
In 2013, Cytokinetics and Astellas formed a
partnership focused on the research, development, and potential
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 initially exclusively licensed to
Astellas rights to co-develop and potentially co-commercialize
reldesemtiv and other FSTAs in non-neuromuscular indications and to
develop and commercialize other novel mechanism, skeletal muscle
activators in all indications. Under the agreement as subsequently
expanded and amended, Astellas also has exclusive rights to
co-develop and commercialize reldesemtiv and other FSTAs in certain
neuromuscular indications (including SMA and ALS). Cytokinetics has
certain development and commercialization rights, including the
right to co-promote FSTAs for neuromuscular indications in the
U.S., Canada and Europe and to co-promote the other collaboration
products in the U.S. and Canada.
About Cytokinetics
Cytokinetics is a late-stage
biopharmaceutical company focused on discovering, developing and
commercializing first-in-class muscle activators and next-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).
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 the potential benefits
of reldesemtiv; Cytokinetics’ continued evaluation
of reldesemtiv as a treatment for patients with ALS; and
the properties and potential benefits of 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,
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
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Feb 2024 to Mar 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Mar 2023 to Mar 2024