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
Ref: Gilead | Image: Gilead
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