December 5, 2019

Impact: High

  • CymaBay Therapeutics has terminated its phase 2b study of PPARδ agonist, seladelpar, in patients with NASH due to atypical histological findings.
  • Planned, blinded histological assessments of liver biopsies from trial participants revealed histology characterized as an interface hepatitis presentation, with or without biliary injury.
  • Notably, the atypical histological findings were observed in patients who demonstrated on-study improvement or stabilization of their biochemical measures of inflammation and liver injury and none of these patients experienced liver-related adverse events after 52 weeks of treatment. Evaluation is ongoing to better understand these findings.
  • The company also terminated its recently initiated phase 2 study of seladelpar in primary sclerosing cholangitis (PSC), and all studies in primary biliary cholangitis (PBC) have been placed on clinical hold.

inThought Analysis

Technically, the source of inflammation does not define the chronic pathology, so we are currently thinking this has more to do with the disease process itself, whether than be NASH or PBC etc., than the therapeutic intervention and we do not believe the entire drug class will be impacted.

Source: CymaBay Press Release