Aclaris shares halved af­ter mid-stage skin dis­or­der fail

A Penn­syl­va­nia biotech missed the mark on mul­ti­ple fronts in a mid-stage tri­al — and in­vestors are not hap­py.

Aclaris Ther­a­peu­tics re­port­ed Mon­day that its can­di­date for mod­er­ate to se­vere hidradeni­tis sup­pu­ra­ti­va (HS) missed pri­ma­ry and sec­ondary ef­fi­ca­cy end­points in a Phase IIa tri­al. Shares of $ACRS fell more than 50% af­ter the Mon­day morn­ing bell.

The place­bo-con­trolled tri­al, ex­am­in­ing the oral MK2 in­hibitor zunseme­tinib in 95 pa­tients ran­dom­ized 1-to-1, failed to meet the pri­ma­ry end­point of a change in base­line of in­flam­ma­to­ry nod­ule/ab­scess count (AN). Pa­tients in the ac­tive arm took a 50 mg dose twice a day for 12 weeks. The study al­so failed to meet sec­ondary ef­fi­ca­cy end­points, in­clud­ing the per­cent­age of pa­tients achiev­ing HiS­CR-50 — an end­point where pa­tients see a 50% re­duc­tion in the to­tal num­ber of ab­scess­es and nod­ules.

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