End of the line for Genfit's experimental NASH drug

Genfit has announced the termination of a late-stage trial testing elafibranor for treatment of nonalcoholic steatohepatitis (NASH) with fibrosis.

The move follows an interim analysis of data from the Phase III RESOLVE-IT trial which showed that the dual PPAR agonist failed to hit its primary efficacy endpoint of NASH resolution without worsening of fibrosis.

Following a detailed review of the available dataset, the company said it 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.

The decision, it noted, is the first step of a new corporate strategy and allows Genfit to accelerate its cost-saving plan and focus efforts on developing two major programmes: elafibranor for primary biliary cholangitis (PBC), and the commercial growth of NIS4, for NASH diagnostics.

“We believe the early termination of RESOLVE-IT is the appropriate decision from an ethical and clinical perspective, and this decision will contribute to accelerating cost savings and to focusing our efforts on our two top priorities: the PBC programme and NIS4, the technology to support a non-invasive diagnostic program in NASH,” said the firm's chief executive Pascal Prigent.