Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
Naturalpha
Development Director Genfit, France

      Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting
      from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis
      and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is
      considered as the most common form of chronic liver disease in adults in the United States,
      Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the
      adult population.

      Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to
      hepatic steatosis associated with inflammation and liver cell injury upon microscopic
      examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and
      deserves serious medical management. Up to now, there is no effective drug which has clearly
      demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the
      resolution of NASH.

      In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the
      treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with
      the metabolic syndrome and type 2 Diabetes.

      This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once
      daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver
      biopsy assessments.
    
Drug