Date: 2017-02-16
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Gilead Sciences (USA - CA)
Product: selonsertib (GS-4997)
Action
mechanism: enzyme inhibitor/kinase inhibitor. GS-4997 is a small-molecule inhibitor of apoptosis signal-regulating kinase 1 (ASK1 or mitogen-activated protein kinase kinase kinase 5 (MAP3K5)), which promotes inflammation, apoptosis and fibrosis in settings of increased oxidative stress associated with NASH pathogenesis. Upon oral administration, ASK1 inhibitor GS-4997 binds to the catalytic kinase domain of ASK1, thereby preventing its phosphorylation and activation. This prevents the phosphorylation of downstream kinases, such as c-Jun N-terminal kinases (JNKs) and p38 mitogen-activated protein kinase (p38 MAPK). By preventing the activation of ASK1-dependent signal transduction pathways, GS-4997 prevents the production of inflammatory cytokines, down-regulates the expression of genes involved in fibrosis, suppresses excessive apoptosis and inhibits cellular proliferation.
Disease: NASH (non-alcoholic steatohepatitis)
Therapeutic area: Hepatic diseases - Liver diseases
Country: USA
Trial
details: STELLAR 4 is a phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib in subjects with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). The primary objective of this study is to evaluate whether selonsertib can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH. (NCT03053063)
Latest
news: * On February 10, 2017, a Phase 3 trial sponsored by Gilead was published on the NIH website ClinicalTrials.gov for selonsertib and is currently recruiting participants.
