Genfit Not Fully Exiting NASH, Despite Terminating RESOLVE-IT

Genfit SA said on 22 July that it is terminating the Phase III RESOLVE-IT study of elafibranor in non-alcoholic steatohepatitis following an in-depth review of interim data, first unveiled in May, which showed the PPAR alpha/delta agonist missed its primary endpoint of resolving NASH without worsening of fibrosis. The French firm also said it now will focus its business on two efforts: Phase III development of elafibranor for primary biliary cholangitis and advancement of its NIS4 biomarker test as an in vitro diagnostic for NASH treatment.

The interim top-line results from the pivotal NASH study were a major blow for Genfit, when they showed a 19.2% response rate for the therapeutic arm compared to 14.7% for...