FDA approves initiation of a Phase IIb study of Genfit's GFT505

French biotech firm Genfit (Alternext: ALGFT) says that the US Food and Drug Administration has approved the continuing development of GFT505 in non-alcoholic steatohepatitis (NASH), and the initiation of a Phase IIb clinical study in the USA.

The FDA approval follows an extensive review of the preclinical and clinical data obtained with GFT505 to date. The FDA experts thus confirm that GFT505 shows a favorable activity on the spectrum of biological markers associated with NASH, together with an excellent safety profile, said Genfit. The agency accepted the proposed Phase IIb protocol, and considered that it met the clinical objectives in NASH, while ensuring patient safety throughout the study. The FDA thus authorizes the immediate initation of this study on the entire US territory.

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