Genfit SA said on 22 July that it is terminating the Phase III RESOLVE-IT study of elafibranor in non-alcoholic steatohepatitis following an in-depth review of interim data, first unveiled in May, which showed the PPAR alpha/delta agonist missed its primary endpoint of resolving NASH without worsening of fibrosis. The French firm also said it now will focus its business on two efforts: Phase III development of elafibranor for primary biliary cholangitis and advancement of its NIS4 biomarker test as an in vitro diagnostic for NASH treatment.
Genfit Not Fully Exiting NASH, Despite Terminating RESOLVE-IT
A fuller look at interim Phase III data shows no path forward to accelerated approval in NASH, company says. Genfit turns focus to developing elafibranor for PBC, as well as a NASH diagnostic.
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