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.
GENFIT will share the full dataset from the interim analysis at an upcoming meeting, likely AASLD, which will be of high interest due to the remaining assets still being evaluated in this drug class. RESOLVE-IT encountered high placebo response rates, and the field will be eager to learn of any trial design elements which may have contributed to this. Full results from the positive phase 2b trial of leading contender lanifibranor will also be presented at AASLD; these data are highly anticipated after lanifibranor outperformed previous frontrunners on key regulatory endpoints.
Source: GENFIT Press Release