July 22, 2020
- GENFIT has officially terminated its pivotal RESOLVE-IT trial of elafibranor for the treatment of NASH with fibrosis after it failed an interim analysis back in May.
- The trial did not meet the predefined primary surrogate efficacy endpoint of NASH resolution without worsening of fibrosis in the ITT population of 1,070 patients.
- Following a detailed review of the full interim efficacy dataset, GENFIT determined that the investment needed to continue the trial was not justified, as it was unlikely to support a regulatory filing.
- The company plans to share key learnings, including upcoming results from the second reading of liver biopsies that will help better understand inter-reader variability and its impact.
- GENFIT will continue to develop elafibranor in primary biliary cholangitis (PBC) and is committed to initiate a phase 3 program following positive phase 2 data in this indication. The company will announce its updated corporate strategy in September 2020.