Genfit (NASDAQ:GNFT) +3.1% pre-market after reporting the Data Safety Monitoring Board issued a positive recommendation for the continuation without modifications of the RESOLVE-IT Phase 3 trial evaluating elafibranor in NASH.
GNFT says the 42-month DSMB safety review supports continuation of the RESOLVE-IT study, which will evaluate the efficacy and safety of elafibranor 120 mg versus placebo in patients with non-alcoholic steatohepatitis and fibrosis.
GNFT expects top-line interim results from the trial, based on the primary endpoint of NASH resolution without worsening of fibrosis, to be announced in Q1 2020; if positive, the company plans to file a new drug application with the U.S. FDA and the European Medicines Agency by year-end 2020.
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