PhI­II fail in Duchenne casts shad­ow over Fi­bro­Gen's top an­ti-fi­brot­ic pro­gram

Fi­bro­Gen has run in­to an­oth­er Phase III dead end with pam­revlum­ab, rais­ing doubts about the fu­ture of its most ad­vanced clin­i­cal pro­gram.

The an­ti­body failed to meet any of the end­points — pri­ma­ry or sec­ondary — in the Phase III LELAN­TOS-2 study in­volv­ing am­bu­la­to­ry pa­tients with Duchenne mus­cu­lar dy­s­tro­phy on back­ground sys­temic cor­ti­cos­teroids.

It’s the third straight Phase III tri­al that pam­revlum­ab has flunked af­ter Fi­bro­Gen re­port­ed dis­ap­point­ing re­sults in non-am­bu­la­to­ry pa­tients with Duchenne mus­cu­lar dy­s­tro­phy, and pa­tients with id­io­path­ic pul­monary fi­bro­sis. In the wake of those neg­a­tive read­outs, the com­pa­ny laid off a third of its staff in Ju­ly.

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