Ipsen, Genfit unveil additional PhIII data for rare liver disease drug, further boosting regulatory ambition
Ipsen and Genfit revealed on Monday that their primary biliary cholangitis (PBC) drug candidate has met additional endpoints in a registrational trial, adding fuel to their approval efforts in a rare disease that needs increased awareness across both physician and patient groups.
The Phase III ELATIVE trial studied once-daily elafibranor versus placebo in 161 PBC patients with poor response or intolerance to standard-of-care ursodeoxycholic acid (UDCA). The new data followed topline readout in June, which showed that elafibranor met the primary endpoint of cholestasis response. However, the drug candidate did not reach significance in the secondary endpoint of reduction in pruritus or itch.
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