While we wait for NASH da­ta, Gen­fit re­ports pos­i­tive elafi­bra­nor da­ta in PBC pa­tients

As a late-stage da­ta show­down from NASH drug de­vel­op­ers Gilead $GILD, In­ter­cept $ICPT and France’s Gen­fit (Eu­roNext: $GN­FT) looms, the Lille-based drug de­vel­op­er on Thurs­day re­port­ed pos­i­tive phase II da­ta on its drug elafi­bra­nor in pa­tients with pri­ma­ry bil­iary cholan­gi­tis (PBC), a rare and pro­gres­sive liv­er dis­ease.

The 12-week phase II tri­al test­ed two dos­es of the dual PPARα/δ ag­o­nist elafi­bra­nor against a place­bo in PBC pa­tients that did not de­rive ad­e­quate ben­e­fit from stan­dard treat­ment, ur­sodeoxy­cholic acid. Both dos­es of the once-dai­ly treat­ment con­ferred a sta­tis­ti­cal­ly sig­nif­i­cant de­crease in serum al­ka­line phos­phatase (ALP) lev­els. High ALP typ­i­cal­ly in­di­cates a liv­er in dis­tress.

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