GENFIT announced that the phase 3 RESOLVE-IT trial of elafibranor in patients with nonalcoholic steatohepatitis (NASH) and fibrosis did not meet its primary and secondary end points.

The multicenter, double-blind, placebo-controlled phase 3 trial evaluated the efficacy and safety of elafibranor in 1070 adult patients with biopsy proven NASH as defined by NAS score greater than or equal to 4 and fibrosis stage 2 or 3. Patients were randomized 2:1 to receive elafibranor 120mg (n=717) or placebo (n=353) once daily, with a follow-up liver biopsy at week 72 to evaluate histologic end points (resolution of NASH without worsening of fibrosis or fibrosis improvement of at least 1 stage). 

The co-primary end points were the proportion of elafibranor-treated patients achieving resolution of NASH without worsening of fibrosis at 72 weeks and the composite long-term outcome composed of all-cause mortality, cirrhosis, and liver-related clinical outcomes for up to 4 years. A key secondary end point included the proportion of elafibranor-treated patients achieving improvement of fibrosis of at least 1 stage at 72 weeks.

Interim results showed a response rate of 19.2% among patients treated with elafibranor compared with 14.7% in the placebo arm (P =.0659). In addition, 24.5% of patients treated with elafibranor achieved fibrosis improvement of at least 1 stage vs 22.4% in the placebo arm (P =.4457). Moreover, changes in metabolic parameters were not observed to be statistically significantly different from placebo.

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“The GENFIT team is actively reviewing the full interim dataset and will be conducting additional analyses, to gain a clearer understanding of the higher than anticipated response rates in the placebo arm,” said Pascal Prigent, CEO of GENFIT. “We plan to share these detailed findings with the regulatory authorities in the coming months and with their guidance, determine a final decision regarding the continuation of the RESOLVE-IT trial.”

Elafibranor is a first-in-class double peroxisome proliferator-activated receptor alpha and delta (PPAR alpha/delta) agonist. In addition to NASH, the drug is being evaluated for the treatment of primary biliary cholangitis.

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