UCB, Bio­gen ad­mit de­feat in PhII lu­pus tri­al, adding to a string of late-stage fail­ures in the field

A late-stage lu­pus pro­gram at UCB and Bio­gen has fol­lowed sev­er­al ri­vals in­to a wall.

With­out pro­vid­ing de­tails, the part­ners re­port­ed that their drug, dapirolizum­ab pe­gol (DZP), had failed to meet the pri­ma­ry end­point, as mea­sured by dose re­sponse at 24 weeks on a scale called the British Isles Lu­pus As­sess­ment Group-based Com­pos­ite Lu­pus As­sess­ment (BI­CLA). The phase IIb tri­al in­volved 182 pa­tients suf­fer­ing from mod­er­ate­ly-to-se­vere­ly ac­tive sys­temic lu­pus ery­the­mato­sus, de­spite stan­dard-of-care treat­ment. Pa­tients in the study were ei­ther giv­en the drug or a place­bo, and al­though in­ves­ti­ga­tors cit­ed con­sis­tent im­prove­ments in pa­tients on the drug, the ex­per­i­men­tal treat­ment did not achieve a sta­tis­ti­cal­ly sig­nif­i­cant (p-val­ue of 0.06) ef­fect.

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