Additional Relevant Details
The decision to halt development of seladelpar was based on initial histological findings observed in the Phase 2b study of seladelpar in NASH. Planned, blinded histological assessments of the first tranche of liver biopsies in the trial revealed atypical histological findings, including histology characterized as an interface hepatitis presentation, with or without biliary injury. The company has initiated a series of investigative actions to better understand these findings.