Aca­dia’s shot at beat­ing a ‘fick­le’ ma­jor de­pres­sion chal­lenge miss­es the mark in a failed PhI­II

Aca­dia’s hit-and-miss record with Nu­plazid (pi­ma­vanserin) has just missed a big Phase III mark by a wide mar­gin.

The biotech $ACAD re­ports that its re­vised late-stage ef­fort on their com­bined CLAR­I­TY-2 and CLAR­I­TY-3 tri­als for ma­jor de­pres­sion — which had each en­rolled about 50% of the pa­tients ini­tial­ly an­tic­i­pat­ed — failed the pri­ma­ry end­point with a p val­ue of 0.296.

The drug did clear the bar on a key sec­ondary end­point, with a mar­gin­al­ly pos­i­tive score on Clin­i­cal Glob­al Im­pres­sion – Sever­i­ty (CGI-S). And it fol­lows a suc­cess­ful Phase II in the first study, where the drug sig­nif­i­cant­ly re­duced HAMD-17.

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