XBiotech rallies after disastrous Xilonix news
It was a bleak Friday for XBiotech (Nasdaq: XBIT), after the USA-based biotech announced the discontinuation of a Phase III trial of its colorectal cancer antibody therapy Xilonix, the firm’s lead monoclonal antibody immunotherapy, which does not seem to have established a generic name.
An Independent Data Monitoring Committee which performed a second prospectively planned, unblinded analysis of the XCITE study had no safety concerns from the unblinded analysis but recommended the early termination of the study since the findings were not sufficient to meet efficacy or the threshold for continuation, which involved a prospectively defined acceptance boundary for the interim analysis of less than or equal to p = 0.08.
That score was labelled “terrible” by biotech analyst John Carroll, writing in Endpoints News, who noted that “very little has gone right” with this drug, which received a negative opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in April.
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