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Wednesday, 07/22/2020 4:52:53 PM

Wednesday, July 22, 2020 4:52:53 PM

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GNFT formally axes NASH drug—will continue work on NASH diagnostics:

https://www.globenewswire.com/news-release/2020/07/22/2066135/0/en/GENFIT-Provides-Initial-Update-on-Corporate-Strategy.html

GENFIT…today announced the discontinuation of the RESOLVE-IT Phase 3 clinical trial of elafibranor in adults with non-alcoholic steatohepatitis (NASH) and fibrosis.

On May 11, 2020, GENFIT announced the results from the interim analysis of the RESOLVE-IT Phase 3 trial, which did not meet the predefined primary surrogate efficacy endpoint of NASH resolution without worsening of fibrosis in the ITT population of 1,070 patients.

Following the detailed review of the full RESOLVE-IT interim efficacy dataset, which involved several experts in the NASH field, GENFIT 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.

In other words, the drug doesn’t work.

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