April 25, 2019
Gilead Announces Topline Data From Phase 3 STELLAR-3 Study of Selonsertib in Bridging Fibrosis (F3) Due to Nonalcoholic Steatohepatitis (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
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
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.
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
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