We previously commented on the failure of the ASK-1 inhibitor, selonsertib, in the STELLAR-4 phase III study in patients with compensated cirrhosis (F4) due to NASH.
Selonsertib has been tested in another study (STELLAR-3) in an earlier stage (F3) of NASH, where it has now been announced that also here, selonsertib failed to meet the primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH.
This is a disappointment to patients and the wider liver fibrosis community, and highlights the challenges in developing treatments for NASH. Reflecting on this result, presentations at the recent EASL meeting, and other observations, we believe that those aiming to develop a therapy in, or considering entering, the liver fibrosis area need to consider a number of factors, summarised in the diagram below.