Gilead to Present Clinical & Preclinical Data on Nonalcoholic Steatohepatitis (NASH) at The International Liver Congress™ 2...
April 20 2017 - 9:30AM
Business Wire
-- Data Underscore Role of Liver Fibrosis as
a Key Driver of NASH Clinical Disease Progression --
-- Additional Data from Phase 2 Selonsertib
Study and Preclinical Combination Data with Selonsertib and GS-9674
also to be Presented --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it
will present data from 15 abstracts on the pathogenesis and
treatment of NASH this week at The International Liver Congress™
2017 in Amsterdam. This includes data Gilead will present during
the opening session of the congress, which indicate that fibrosis
is the primary determinant of NASH clinical disease progression
(#GS-004). Gilead will also present data on investigational
compounds targeting distinct mechanisms of action being studied
individually, and as combination therapies, for the treatment of
NASH.
NASH is a chronic liver disease associated with steatosis, or
accumulation of fat within the liver, that can lead to
inflammation, progressive fibrosis and cirrhosis. The median
survival for a NASH patient with cirrhosis (F4) is approximately
five years.
While found to be ineffective for reducing liver fibrosis in
patients with NASH, Phase 2b studies of simtuzumab, have generated
important data on the clinical progression of the disease. These
analyses indicate that the primary determinant of progression to
cirrhosis in patients with bridging fibrosis or to events of
hepatic decompensation in patients with cirrhosis is the fibrosis
stage at baseline, and its change over time. Data from the
simtuzumab studies also show that modest weight loss (≥5 percent of
body weight), observed in approximately 10 percent of patients,
does not reduce progression to cirrhosis in NASH patients with
bridging fibrosis, and that weight loss did not prevent hepatic
decompensation in patients with cirrhosis (#SAT-318, #THU-362).
“These analyses provide important insights into the natural
history of NASH, especially among patients with advanced disease,”
said Arun J. Sanyal, MD, lead study author and Professor of
Medicine, Physiology and Molecular Pathology, School of Medicine at
Virginia Commonwealth University. “The results indicate that liver
fibrosis is a key focus for therapeutic intervention.”
“NASH patients with advanced fibrosis or cirrhosis face the
greatest risk of clinical complications and have the most urgent
need for therapeutic options,” said Norbert Bischofberger, PhD,
Executive Vice President of Research and Development and Chief
Scientific Officer at Gilead. “Clinical trials across Gilead’s NASH
pipeline are focused on this patient group, with the goal of
reversing fibrosis and reducing disease progression in patients
with advanced fibrosis.”
Selonsertib Studies
Several abstracts to be presented at the conference provide new
insight into the potential of selonsertib, an investigational
apoptosis signal-regulating kinase 1 (ASK1) inhibitor, in NASH
patients with advanced fibrosis. Additional analyses from an
open-label Phase 2 study of selonsertib indicate that improvement
in liver fibrosis observed with selonsertib treatment was
associated with consistent reductions in several noninvasive
measures, including markers of liver cell death and inflammation
(#PS-090), liver stiffness as assessed by magnetic resonance
elastography (MRE) and liver fat as assessed by MRI-proton density
fat fraction (PDFF) (#SAT-489, #SAT-483). Patients with fibrosis
regression due to selonsertib also reported improved
patient-reported outcomes (#PS-092). Collectively, these data
demonstrate the consistency of the anti-fibrotic effects of
selonsertib and highlight the potential of noninvasive assessment
in monitoring response to treatment. An additional analysis from
this study to be presented during an oral session also demonstrated
accelerated aging based on an epigenetic clock, that is associated
with the severity of fibrosis in patients with NASH (#PS-093).
Combination Therapy Data
Gilead will also present data from a preclinical study for an
investigational combination of NASH therapies targeting different
mechanisms of action. In a mouse model of NASH, treatment with the
combination of an ASK1 inhibitor and GS-9674, an investigational
non-steroidal Farnesoid X receptor (FXR) agonist, demonstrated
greater reduction in hepatic steatosis and in the expression of
genes associated with fibrosis compared to either agent alone
(#PS-030). The preclinical data also demonstrate that ASK1 and FXR
help regulate independent pathways contributing to NASH, supporting
the investigation of the combination of selonsertib and GS-9674 in
patients with NASH.
Further information about the clinical studies described above
can be found at www.clinicaltrials.gov.
About Gilead’s Clinical Programs in
NASH
Gilead is advancing a pipeline of novel investigational
therapies for the treatment of NASH with advanced fibrosis. Gilead
is currently planning or conducting Phase 2 and Phase 3 clinical
trials evaluating single-agent and combination therapy approaches
against multiple core pathways associated with NASH – metabolic
dysregulation, inflammation and fibrosis. Compounds in development
include an ASK1 inhibitor, selonsertib; an FXR agonist, GS-9674;
and GS-0976, an inhibitor of Acetyl-CoA Carboxylase (ACC). Phase 3
trials evaluating selonsertib among NASH patients with bridging
fibrosis (F3) or cirrhosis (F4) are ongoing (the STELLAR program).
GS-9674 and GS-0976 are currently in Phase 2 studies.
Selonsertib, GS-9674, and GS-0976, alone and in combination, are
investigational therapies and have not been determined to be safe
or efficacious.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company’s mission is to advance the care of
patients suffering from life-threatening diseases. Gilead has
operations in more than 30 countries worldwide, with headquarters
in Foster City, California.
Forward-Looking
Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including Gilead’s ability to complete its Phase 2 and Phase 3
clinical trial programs evaluating selonsertib, GS-9674 and GS-0976
in patients with NASH in the currently anticipated timelines or at
all. In addition, there is the possibility of unfavorable results
from further clinical trials involving these compounds. Further, it
is possible that Gilead may make a strategic decision to
discontinue development of selonsertib, GS-9674 and GS-0976 if, for
example, Gilead believes commercialization will be difficult
relative to other opportunities in its pipeline. As a result,
selonsertib, GS-9674 and GS-0976 may never be successfully
commercialized. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the forward-looking statements. The reader is cautioned not to rely
on these forward-looking statements. These and other risks are
described in detail in Gilead’s Annual Report on Form 10-K for the
year ended December 31, 2016, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com, follow Gilead on
Twitter (@GileadSciences) or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000
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