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Gilead's former NASH pipeline candidates show treatment effect in mid-stage study

Published 11/14/2016, 06:41 PM
Gilead's former NASH pipeline candidates show treatment effect in mid-stage study
GILD
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  • Results from an open-label Phase 2 clinical trial assessing Gilead Sciences' (NASDAQ:GILD) selonsertib (GS-4997) alone or combination with simtuzumab (SIM) in patients with nonalcoholic steatohepatitis (NASH) and moderate-to-severe liver fibrosis (stages F2 or F3) showed a treatment effect favoring the combination. The data were presented at The Liver Meeting 2016 in Boston, MA.
  • Four measures of liver disease were assessed in three groups of patients: those receiving selonsertib 18 mg with/without SIM; selonsertib 6 mg with/without SIM and SIM alone. There were no differences observed between the combination and selonsertib alone.
  • The proportions of subjects experiencing at least one stage improvement in fibrosis in the three groups were 43% (n=13/30), 30% (n=8/27) and 20% (n=2/10), respectively.
  • The proportions that progressed to cirrhosis were 3% (n=1/30), 7% (n=2/27) and 20% (n=2/10), respectively.
  • The proportions that experienced at least a 15% reduction in liver stiffness were 20% (n=5/25), 32% (n=7/22) and 0% (n=0/7), respectively.
  • The proportions that experienced at least a 30% reduction in liver fat were 26% (n=8/31), 13% (n=3/24) and 10% (n=1/10), respectively.
  • Headache, nausea and sinusitis were the most common selonsertib-related adverse events.
  • The treatment effect of both selonsertib and SIM were not enough for Gilead, though. The company recently terminated both development programs in NASH.
  • Previously: Gilead quietly stops development of certain pipeline programs (Nov. 3)

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