A phase 2 trial of Genfit’s elafibranor in primary biliary cholangitis has hit its primary endpoint. The readout sets Genfit up to start a pivotal trial in PBC and thereby expand its late-phase pipeline beyond NASH.
Elafibranor is one of a small band of drugs barreling toward phase 3 NASH readouts. That upcoming data drop remains the key moment in the near-term future of the peroxisome proliferator-activated receptor agonist. But with a U.S. listing in the works, the PBC readout gives Genfit a chance to show its fate is tied to more than just those results.
Investigators enrolled 45 patients with the chronic liver disease PBC who had tried ursodeoxycholic acid without success. Levels of serum alkaline phosphatase fell 48% and 41% in the 80 mg and 120 mg elafibranor arms of the study, compared to a 3% increase in the placebo cohort.
Elafibranor also performed well against a composite secondary endpoint previously used to support the approval of Intercept Pharmaceuticals’ Ocaliva. The two treatment arms recorded response rates of 67% to 79% against the endpoint, which looked at the proportion of patients to achieve a 15% or greater reduction in ALP and bilirubin. The placebo response rate was 6.7%. Ocaliva came to market with a response rate of 47%.
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Genfit plans to move into phase 3 on the strength of the midphase data. That puts Genfit on the heels of CymaBay Therapeutics, which is already in phase 3 with seladelpar and due to wrap up its pivotal studies late in 2020.
A comparison of the midphase data generated on elafibranor and seladelpar suggests Genfit’s drug should at least be competitive, although the current lack of information about the characteristics of its subjects at baseline makes it hard to draw firm conclusions. Even so, analysts at Kepler Cheuvreux saw enough in the data to say that “elafibranor should become the gold standard of PBC treatment.”
Date: December 12, 2018
Source: FierceBiotech
