Shares in Genfit (GNFT) crashed 49% in after-hours trading on Monday after the late-stage biopharma announced disappointing results from an interim analysis of the RESOLVE-IT Phase 3 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.
“These results are highly disappointing, not only for the GENFIT team, but also for patients and healthcare providers as there continues to be considerable unmet medical need in the NASH space” commented Pascal Prigent, CEO of Genfit.
The GENFIT team is actively reviewing the full interim dataset, said Prigent, and will conduct additional analyses to gain a clearer understanding of the higher than anticipated response rates in the placebo arm.
“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” the CEO said.
The full dataset will be presented at one of the international hepatology meetings in the second half of 2020. Safety and tolerability of elafibranor was similar to previously conducted trials.
Prigent revealed that the company will continue as planned with the NIS4TM and Phase 3 PBC (primary biliary cholangitis) programs, which are independent of the NASH elafibranor program.
“We are not terribly surprised elafibranor failed in the RESOLVE-IT Phase 3 study in NASH as we were pretty skeptical ahead of results based on our diligence into elafibranor’s Phase 2 data and its mechanism” says Stifel Nicolaus analyst Derek Archila.
He has a hold rating on GNFT, arguing that the stock is now likely to remain range bound until management provides an update in the fall for elafibranor in NASH.
However, there is a glimmer of hope- elafibranor’s program in primary biliary cholangitis (PBC). Archila thinks here GNFT has solid proof-of-concept data from both an efficacy and safety perspective, and that this could provide a floor for shares.
“Until it is certain management plans terminate NASH and move forward with PBC as the lead indication, where it can benefit from orphan pricing, we remain on the sidelines” he explains.
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