Genfit’s NASH drug fails Phase 3 clinical trial

pharmafile | May 12, 2020 | News story | Manufacturing and Production FDA, nash 

The Phase 3 trial for Genfit’s drug elafibranor has failed to improve outcomes for patients with the fatty liver disease NASH.

This study enrolled over 1,000 patients who had NASH, including measurable levels of liver fibrosis. After 72 weeks, 19% of the patients treated with elafibrinor showed NASH resolution compared to 15% of the patients treated with placebo. The study failed to achieve its primary endpoint as this difference was not statistically significant. In terms of its secondary goal, the drug also failed to reduce liver fibrosis significantly more than placebo.

The company believes the Phase 3 trial failed due to the placebo having a higher than expected response. However, this is not the first time elafibranor has performed poorly in a study. In 2015, it also failed to show any improvements in NASH symptoms compared to a placebo.

Genfit CEO Pascal Prigent said the results of the study were “highly disappointing.”

Intercept Pharmaceutical’s drug called obeticholic acid remains on track to be the first treatment for NASH after its earlier approval by the FDA for the treatment. It will be reviewed by the FDA on 9 June who will have a final decision by 24 June.

Conor Kavanagh

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