-- New Proof-of-Concept Data for Combination
of Investigational FXR Agonist Cilofexor and ACC Inhibitor
Firsocostat in NASH --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data
from the company’s clinical research program in nonalcoholic
steatohepatitis (NASH) being presented at The International Liver
Congress™ 2019 in Vienna. The data support Gilead’s efforts to
develop combination therapies to target different aspects of NASH,
evaluate the utility of noninvasive tests for the identification of
patients living with the disease and advance overall understanding
of the complexities and burden of NASH.
“NASH is a complex disease with multiple biological pathways
that influence its progression. Combination therapeutic approaches
which target these pathways, are likely to be needed to effectively
treat patients living with NASH, particularly those with advanced
fibrosis who have the greatest unmet need,” said John McHutchison,
AO, MD, Chief Scientific Officer, Head of Research and Development,
Gilead Sciences. “We are encouraged by the results of our
proof-of-concept study being presented this week and look forward
to sharing further combination data from the Phase 2 ATLAS trial
later this year.”
Combination Therapy Treatment for NASH
A proof-of-concept study demonstrated that the combination of
the investigational, selective, non-steroidal farnesoid X receptor
(FXR) agonist cilofexor (GS-9674) and the acetyl-CoA carboxylase
(ACC) inhibitor firsocostat (GS-0976) resulted in improvements in
hepatic steatosis, liver stiffness, liver biochemistry and serum
fibrosis markers. In the study, 20 patients with NASH received
cilofexor 30 mg and firsocostat 20 mg orally once daily for 12
weeks. A significant decline of at least 30 percent in hepatic fat
measured by magnetic resonance imaging-proton density fat fraction
(MRI-PDFF) from baseline to 12 weeks was observed in 74 percent of
patients. Improvements in liver biochemistry tests including serum
ALT (median relative reduction, -37%; p<0.001) and GGT (-32%;
p<0.001), along with markers of reduced bile acid synthesis,
were observed at 12 weeks. Treatment was well tolerated and
pruritus was not reported in any patients. Asymptomatic, Grade 3
hypertriglyceridemia was observed in two patients. No patients
withdrew from the study due to adverse events.
Noninvasive Tests
Liver biopsy is currently the reference standard to identify
patients with NASH but is an invasive and costly procedure with
potential for serious complications. Gilead will present an
analysis of screening data from its Phase 2 ATLAS study evaluating
combinations of investigational cilofexor, firsocostat and
selonsertib in advanced fibrosis due to NASH.
This analysis demonstrates that the use of currently available
noninvasive tests (NITs) can accurately identify patients with
advanced fibrosis due to NASH and potentially reduce the need for
liver biopsy. When used in combination, the Enhanced Liver Fibrosis
(ELF) test and FibroScan® accurately identified advanced fibrosis
in >80 percent of patients.
Cilofexor and firsocostat, alone or in combination, are
investigational compounds and are not approved by the U.S. Food
& Drug Administration (FDA) or any other regulatory authority.
Safety and efficacy have not been established for these agents.
Burden of Disease and Patient-Reported Outcomes
While NASH can have non-specific symptoms, research is needed to
understand the impact of disease on quality of life for those
living with the condition, measured through patient-reported
outcomes (PROs). Baseline data from the STELLAR Phase 3 trials
showed significant burden of disease among people with advanced
fibrosis due to NASH. In 1,667 patients enrolled in the STELLAR
trials, PROs assessed using tools including the Chronic Liver
Disease Questionnaire (CLDQ-NASH) prior to treatment, particularly
those related to physical health-related scores, were significantly
lower than those of population norms. In another analysis of
patients enrolled in the STELLAR program, diabetes mellitus was
associated with impairment in PROs including physical functioning,
bodily pain, general health and vitality. An additional study
assessing health-related quality of life in 1,338 patients with
advanced fibrosis due to NASH demonstrated that these individuals
have more impairment of their physical health-related scores than
patients with chronic hepatitis C virus.
About Gilead’s Clinical Programs in
NASH
NASH is a chronic and progressive liver disease characterized by
fat accumulation and inflammation in the liver, which can lead to
scarring, or fibrosis, that impairs liver function. Individuals
living with fibrosis are at a significantly higher risk of
liver-related mortality and all-cause mortality.
Gilead is advancing multiple novel investigational compounds for
the treatment of advanced fibrosis due to NASH, evaluating
single-agent and combination therapy approaches against the core
pathways associated with NASH – hepatocyte lipotoxicity,
inflammation and fibrosis. Investigational compounds in development
include the ASK1 inhibitor selonsertib, the selective,
non-steroidal FXR agonist cilofexor (GS-9674) and the ACC inhibitor
firsocostat (GS-0976). The STELLAR-3 Phase 3 trial evaluating
selonsertib among NASH patients with bridging fibrosis (F3) is
ongoing. Cilofexor and firsocostat are currently in Phase 2 studies
in NASH, including the ATLAS trial evaluating combinations of
selonsertib, cilofexor and firsocostat in advanced fibrosis (F3 and
F4) due to NASH.
Selonsertib is an investigational compound and is not approved
by the U.S. Food & Drug Administration (FDA) or any other
regulatory authority.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City,
California. For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com.
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 clinical
trial programs evaluating single-agent and combination therapy
approaches, including selonsertib, cilofexor and/or firsocostat, 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, cilofexor and/or
firsocostat if, for example, Gilead believes commercialization will
be difficult relative to other opportunities in its pipeline. As a
result, the compounds 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, 2018, 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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Sung Lee, Investors(650) 524-7792
Arran Attridge, Media(650) 425-8975
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