Gilead Reports Results of Selonsertib in P-III STELLAR 3 Study for Bridging Fibrosis (F3) due to NASH

 Gilead Reports Results of Selonsertib in P-III STELLAR 3 Study for Bridging Fibrosis (F3) due to NASH

Gilead Reports Results of Selonsertib in P-III STELLAR 3 Study for Bridging Fibrosis (F3) due to NASH

Shots:

  • The P-III STELLAR 3 study involves assessing of Selonsertib (18mg, 6mg) vs PBO in 802 patients with F3/bridging fibrosis due to NASH in adults aged 18 to 70yrs for 240wks.
  • The P-III study results: @48 wks. did not meet its 1EPs; ≥ 1-stage improvement in fibrosis without NASH worsening (9.3%, 12.1% vs 13.2%); well tolerated
  • Selonsertib (qd, PO) is a signal-regulating kinase 1 (ASK1) inhibitor and is evaluated in P-II ATLAS study in combination with selonsertib, cilofexor and firsocostat in patients with advanced fibrosis due to NASH with its expected results in H2’19. In H1’19, P-III study assessing Selonsertib in patients with F4 fibrosis has also failed in meeting its 1EPs

Click here to read full press release/ article | Ref: Gilead | Image: Glassdoor