Elafibranor (GFT505) is Genfits lead pipeline product. Its an oral once-daily treatment, positioned as a first-in-class drug to treat nonalcoholic steatohepatitis (NASH). Based on the beneficial activities that it demonstrates on the different features of the pathology, Elafibranor represents the ideal drug for NASH patients, including those suffering from the most severe forms of the disease.
The new non-proprietary name, Elafibranor, reflects the first-in-class nature of the drug candidate, since it does not contain a pre-existing INN stem. The novel pre-stem -fibranor may thus become an established stem over time, as other later developed drugs are recognized to be related in structure or activity.
Phase 3 launch in 2015
In March 2015, Genfit announced topline results from the phase 2b GOLDEN-505 trial in NASH (GFT505-2127) in which Elafibranor has been tested for clinical efficacy in NASH in a 1-year liver biopsy-based Phase 2b trial (GFT505-2127), one of the largest interventional studies ever conducted in NASH: