Genfit announced the phase 3 RESOLVE-IT study will be terminated 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 provide results that would be sufficient to support elafibranor for registration in NASH in the USA and Europe. Genfit previously announced interim results which showed 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. Genfit is working with the RESOLVE-IT investigators to expedite the trial termination process and will meet with regulatory agencies to share key findings from the trial.
Genfit is shifting its strategic focus on developing two major programs: elafibranor development in Primary biliary cholangitis (PBC), and the commercial growth of NIS4, for NASH diagnostics.
Elafibranor demonstrated promising results in a Phase 2 clinical trial for PBC and Genfit’s clinical team is now fully focused on the initiation of the Phase 3 clinical trial.
Increased ease of NASH diagnosis and treatment efficacy evaluation are critical both for patients and healthcare professionals, but also for regulatory authorities and payers. With the NIS4 program, Genfit plans to develop efficient and cost-effective non-invasive solutions, to address this growing need.
Elafibranor is an oral, once-daily, first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways.
The FDA and EMA have granted Elafibranor Orphan Drug Designation for Primary Biliary Cholangitis and the FDA has granted a Breakthrough Therapy Designation for PBC.