Clinical trials evaluating seladelpar for the treatment of non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) have been halted after atypical histological findings were observed in a phase 2b study in NASH patients.

Seladelpar is a potent and selective peroxisome proliferator-activated receptor delta agonist. According to CymaBay Therapeutics, histological assessments of liver biopsies in the phase 2b trial revealed “an interface hepatitis presentation, with or without biliary injury.” An investigation into these findings is ongoing; in the meantime, the Company will put trials evaluating seladelpar in patients with primary biliary cholangitis (PBC) on hold.   

“The atypical histological findings in the NASH phase 2b clinical study of seladelpar were observed in patients who demonstrated on-study improvement or stabilization of their biochemical measures of inflammation and liver injury and no liver-related adverse events after 52 weeks of treatment,” stated Sujal Shah, CEO of CymaBay. “However, in light of the findings, we have decided to terminate our NASH and PSC studies and place our PBC studies on hold pending further review and follow-up.”

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