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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