Genfit up 8% after DSMB issues positive recommendation for NASH trial
Genfit this morning announced that the Data Safety Monitoring Board issued a positive recommendation for the continuation, without any modifications, of the Resole-It Phase 3 trial evaluating elafibranor in nonalcoholic steatohepatitis. The company added, "The 42-month DSMB safety review supports GENFIT's continuation of the RESOLVE-IT study. This DSMB recommendation marks the seventh review with no safety signals that would justify modification or discontinuation of the study, including review of safety data from patients in the study who have received elafibranor for as long as three years." Top-line interim results from the Phase 3, Resole-It trial, based on the primary endpoint of NASH resolution without worsening of fibrosis, are expected to be announced in Q1 of 2020. If positive, Genfit aims to file a new drug application with the Food and Drug Administration and the European Medicines Agency by the end of 2020. Elafibranor has received fast track designation from the FDA for the treatment of NASH. Shares of Genfit are up 8%, or $1.13, to $14.68 in afternoon trading.