February 11, 2019
Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
In the study of 877 enrolled patients who received study drug, 14.4 percent of patients treated with selonsertib 18 mg (p=0.56 vs. placebo) and 12.5 percent of patients treated with selonsertib 6 mg (p=1.00) 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, compared with 12.8 percent of patients who received placebo. Selonsertib was generally well-tolerated and safety results were consistent with prior studies.
“While we are disappointed that the STELLAR-4 study did not achieve its
primary endpoint, we remain committed to advancing therapies for
patients with advanced fibrosis due to NASH, where there is a
significant unmet need for effective and well-tolerated treatments.
Gilead has a long-term commitment and proven track record of addressing
significant challenges in the field of liver diseases. Data from this
large study of patients with compensated cirrhosis due to NASH,
including the extensive set of biomarkers collected, will further
advance our understanding of the disease and inform our broader NASH
development programs,” said
Further in-depth analysis of the findings is ongoing and the data will be submitted to an upcoming scientific conference. Gilead will work with the Data Monitoring Committee and investigators to conclude the STELLAR-4 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-4 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-4 study is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib in patients with compensated cirrhosis (F4) due to NASH. Eligible adults ages 18 to 70 years were randomized and received selonsertib 18 mg (n=354), selonsertib 6 mg (n=351) or placebo (n=172) for up to 240 weeks. Either selonsertib or placebo is being administered 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 at week 48 and event-free survival at week 240 as assessed by time to the first clinical event. 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, including bridging fibrosis (F3) or compensated cirrhosis (F4), 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 Phase 2 trial evaluating combinations of selonsertib, cilofexor and firsocostat 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-Q for the quarter ended
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