Cytokinetics Announces Presentation of Additional Analyses From FORTITUDE-ALS at the 18th Annual NEALS Meeting
October 04 2019 - 7:30AM
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced
additional analyses of 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). Post-hoc analyses relating to
the effect of reldesemtiv on the change in ALS Functional Rating
Scale – Revised (ALSFRS-R) total score observed during the trial
were presented by Jeremy M. 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, at the 2019
Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting in
Clearwater Beach, FL.
The post-hoc analyses evaluated change in
ALSFRS-R from baseline based on patients’ estimated rate of
pre-trial disease progression. Patients were divided into faster,
middle, and slower progression tertiles, based on their onset date
of ALS symptoms and their ALSFRS-R total score at baseline. Results
of these analyses showed that, in the combined middle and faster
progressing tertiles, the decline in ALSFRS-R total score from
baseline to week 12 was smaller in patients who received any dose
of reldesemtiv versus placebo (LS mean treatment difference 1.15, p
= 0.011), while no significant difference was observed in slower
progressing patients who received reldesemtiv versus placebo.
Additionally, use of durable medical equipment (DME, including
manual wheelchair, power wheelchair, non-invasive ventilator,
feeding tube, and speech generating device) was numerically reduced
in all dosing groups treated with reldesemtiv compared to placebo.
Combining all doses of reldesemtiv, the hazard ratio compared to
placebo was 0.62 (CI 0.40, 0.954, p = 0.027). These analyses showed
statistically significant differences in the decline in ALSFRS-R in
the combined group of middle and faster progressing tertiles of
patients who received any dose of reldesemtiv, and that the timing
and use of DME may have been affected by treatment with
reldesemtiv, which suggests a potential clinical benefit for
patients.
“It’s encouraging to see that faster and middle
progressing tertiles of patients treated with reldesemtiv
experienced a significant slowing of disease progression,” said
Fady I. Malik, MD, PhD, Cytokinetics’ Executive Vice President,
Research and Development. “These data indicate that, although
FORTITUDE-ALS did not achieve statistical significance in the
primary analysis of change from baseline in slow vital capacity
(SVC) or a similar analysis for ALSFRS-R, favorable outcomes of
treatment with reldesemtiv appear evident in more rapidly
progressing patients, which supports continued evaluation of
reldesemtiv as a treatment for patients with ALS.”
About FORTITUDE-ALS
FORTITUDE-ALS was a Phase 2, double-blind,
randomized, dose-ranging, placebo-controlled, parallel group study
of reldesemtiv in patients with ALS. 458 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
or placebo dosed orally twice daily for 12 weeks. The primary
efficacy endpoint was the change from baseline in the percent
predicted SVC, a measure of respiratory function, at 12 weeks.
Secondary endpoints included change from baseline in the ALSFRS-R
total score and the slope of the change from baseline in the
mega-score of muscle strength measured by hand held dynamometry and
handgrip dynamometry in patients on reldesemtiv; incidence and
severity of treatment-emergent adverse events (TEAEs); and plasma
concentrations of reldesemtiv at the sampled time points during the
clinical trial. Data from FORTITUDE-ALS were presented at the
American Academy of Neurology Annual Meeting in Philadelphia in May
2019 and showed that the trial did not achieve statistical
significance for a pre-specified dose-response relationship in the
primary endpoint (p=0.11). Similar analyses of the ALSFRS-R total
score and the slope of the Muscle Strength Mega-Score yielded
p-values of 0.09 and 0.31, respectively. However, patients on all
dose groups of reldesemtiv declined numerically less than patients
on placebo for SVC and ALSFRS-R, with larger and clinically
meaningful differences emerging over time.
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
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) for diseases of
neuromuscular dysfunction, including SMA and ALS. 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
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