Results from interim analysis of RESOLVE-IT phase III trial of elafibranor in adults with NASH and fibrosis. Genfit

Genfit announced results from an interim analysis of the RESOLVE-IT Phase III trial evaluating once-daily, 120mg of elafibranor in adults with non-alcoholic steatohepatitis (NASH).

The trial did not meet the predefined primary endpoint of NASH resolution without worsening of fibrosis in the ITT population of 1,070 patients. The response rate in the 717 patients enrolled on study drug was 19.2% for patients who received elafibranor 120mg compared to 14.7% for patients in the placebo arm. On the fibrosis key secondary endpoint, 24.5% of patients who received elafibranor 120mg achieved fibrosis improvement of at least one stage compared to 22.4% in the placebo arm. The other key secondary endpoint related to metabolic parameters did not achieve statistical significance.

Interim Results The RESOLVE-IT Phase III trial evaluated the effect of elafibranor compared to placebo in 1,070 patients (ITT population) with biopsy proven NASH as defined by NAS greater than or equal to 4, fibrosis stage 2 or 3. Patients were randomized 2:1 to receive elafibranor 120mg or placebo once daily, with a follow-up liver biopsy at week 72 to evaluate histologic endpoints (resolution of NASH without worsening of fibrosis or fibrosis improvement of at least one stage). Patients with no biopsy results at week 72 were considered as non-responders in the efficacy analysis.The full dataset will be presented at one of the international hepatology congresses that will take place in the second half of 2020.