Gilead Announces Topline Data From Phase 3 STELLAR-3 Study of Selonsertib in Bridging Fibrosis (F3) Due to Nonalcoholic Steat...
April 25 2019 - 8:00AM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that
STELLAR-3, a Phase 3, randomized, double-blind, placebo-controlled
study evaluating the safety and efficacy of selonsertib, an
investigational, once daily, oral inhibitor of apoptosis
signal-regulating kinase 1 (ASK1), for patients with bridging
fibrosis (F3) due to nonalcoholic steatohepatitis (NASH), did not
meet the pre-specified week 48 primary endpoint of a ≥ 1-stage
histologic improvement in fibrosis without worsening of NASH.
In the study of 802 enrolled and dosed patients, 9.3 percent of
patients treated with selonsertib 18 mg (p=0.42 versus placebo) and
12.1 percent of patients treated with selonsertib 6 mg (p=0.93)
achieved a ≥ 1-stage improvement in fibrosis according to the NASH
Clinical Research Network (CRN) classification without worsening of
NASH after 48 weeks of treatment, versus 13.2 percent with placebo.
Selonsertib was generally well tolerated and safety results were
consistent with prior studies.
“While we had hoped for different outcomes from the STELLAR
program, we remain focused and committed to developing highly
effective treatments for patients living with advanced fibrosis due
to NASH. We are actively exploring the STELLAR data and will work
with external collaborators like PathAI and insitro, to further our
understanding of this complex disease and advance our development
programs. We thank the patients and their physicians who
participated in the STELLAR program for contributing to these
efforts,” said John McHutchison, AO, MD, Chief Scientific Officer
and Head of Research and Development, Gilead Sciences. “We believe
that effective therapy for NASH will ultimately require a
combination approach that targets distinct pathways involved in the
pathogenesis of this disease. In this regard, we look forward to
data from the Phase 2 ATLAS combination trial of selonsertib,
cilofexor and firsocostat in patients with advanced fibrosis due to
NASH, which will be available later this year.”
Gilead will now work with the Data Monitoring Committee and
investigators to conclude the STELLAR-3 study in a manner
consistent with the best interests of each patient.
Selonsertib, 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.
About Selonsertib and the STELLAR-3
Study
Selonsertib is an investigational small molecule inhibitor of
ASK1, a protein that promotes inflammation, apoptosis (cell death)
and fibrosis in settings of oxidative stress. Oxidative stress can
be increased in many pathological conditions including liver
diseases such as NASH.
The STELLAR-3 study is a Phase 3, randomized, double-blind,
placebo-controlled study evaluating the safety and efficacy of
selonsertib in patients with bridging fibrosis (F3) due to NASH.
Eligible adults ages 18 to 70 years were randomized to receive
selonsertib 18 mg (n=322), selonsertib 6 mg (n=321) or placebo
(n=159) for up to 240 weeks, orally once daily. The primary
endpoints of the study are a composite of the proportion of
patients who achieve a ≥ 1-stage improvement in fibrosis according
to the NASH CRN classification without worsening of NASH as defined
by the NAFLD activity score (NAS) at week 48 and event-free
survival at week 240 as assessed by time to the first clinical
event. Secondary endpoints include the proportion of patients who
have a ≥ 1-stage improvement in fibrosis without worsening of NASH
at week 240, and the proportion of patients who have NASH
resolution without worsening of fibrosis at week 48 and week 240.
Further information about the clinical study can be found at
www.clinicaltrials.gov.
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
with advanced 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, and the ACC inhibitor,
firsocostat, which are being studied in the Phase 2 ATLAS trial as
single agents and combinations in advanced fibrosis (F3 and F4) due
to NASH.
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 Quarterly 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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