AASLD 2019 — Selonsertib does not improve fibrosis in NASH


  • Brandon May
  • Conference Reports
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Takeaway

  • Selonsertib monotherapy is not effective for improving disease in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH).

Why this matters

  • Additional data are needed to identify the effect of selective inhibitors of apoptosis signal-regulating kinase 1—like selonsertib—for reducing common events associated with NASH.

Study design

  • Findings were from 2 phase 3 randomized controlled trials (STELLAR-3 and STELLAR-4).
  • Patients with NASH and bridging fibrosis or compensated cirrhosis were randomly assigned to once-daily selonsertib 18 mg (n=322), selonsertib 6 mg (n=321), or placebo (n=159) for up to 240 weeks.
  • Primary endpoint: proportion of patients with ≥1-stage improvement in fibrosis at week 48.
  • Secondary endpoints: changes in noninvasive tests (NITs) of fibrosis and adjudicated cirrhosis-related clinical events.
  • Funding: Gilead Sciences.

Key results

  • In STELLAR-3, selonsertib 18 mg was not superior to placebo for achieving the primary endpoint at 48 weeks (9.3% vs 13.2%; P=.42).
  • No difference was observed between selonsertib 6 mg and placebo in the proportion of patients achieving the primary endpoint (12.1% vs 13.2%; P=.93).
  • In the STELLAR-4 trial, no difference was found between the 2 selonsertib doses and placebo with regard to the primary endpoint.
  • Selonsertib did not significantly effect the liver, NITs of fibrosis, or clinical events (data not reported).

Limitations

  • The study looked at selonsertib as monotherapy only.