Genfit Says Safety/Tolerability Will Give Elafibranor An Edge In NASH

Lack of pruritus and a positive cardiometabolic profile could give elafibranor an advantage as it competes with Intercept’s Ocaliva to be the first drug therapy to market in NASH. The French biotech also is working on a biomarker algorithm to optimize patient selection.

With two companies in Phase III in non-alcoholic steatohepatitis (NASH) and another candidate on the cusp of pivotal trials, Genfit SA is making an argument that its elafibranor – advancing on roughly the same timeline as the other Phase III candidate, Intercept Pharmaceuticals Inc.’s Ocaliva – will hold an edge due to a better safety and tolerability profile and emerge as the therapy of choice in first-line usage.

Chief Scientific Officer/Chief Operating Officer Dean Hum conceded in an interview that elafibranor – a peroxisome proliferator accelerator receptor (PPAR) alpha/delta agonist – has shown relatively similar efficacy in clinical studies compared to the farnesoid X receptor (FXR) agonist Ocaliva (obeticholic acid)

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