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ARTICLE | Clinical News

Genfit's elafibranor meets in Phase II for primary biliary cholangitis

December 7, 2018 6:24 PM UTC

Genfit S.A. (Euronext:GNFT) said both doses of elafibranor (GFT505) met the primary endpoint in a Phase II trial to treat primary biliary cholangitis (PBC). The company said it believes the strength of the data qualify the program to rapidly advance into Phase III testing for the indication.

The double-blind, international trial enrolled about 45 patients who had an inadequate response to ursodeoxycholic acid (UDCA) to receive placebo or once-daily 80 or 120 mg oral elafibranor for 12 weeks. On the primary endpoint, elafibranor significantly reduced mean serum alkaline phosphatase levels (ALP) from baseline to week 12 by 48% at the 80 mg dose and by 41% at the 120 mg dose vs. an increase of 3% for placebo (p<0.001 for both)...