It’s possible Austin-based XBiotech just doesn’t get it.
The EMA’s Committee for Medicinal Products for Human Use — the CHMP — put together an informal trend vote on the biotech’s application for Xilonix as a new drug for colorectal cancer, providing a hard signal the formal vote will go against XBiotech after concluding the biotech has no data to prove that the drug works.
Likely outcome: outright rejection. XBiotech’s shares cratered, dropping 35% on its latest setback, which has been coming hard and fast.
Back in late 2015 XBiotech outlined a series of embarrassing pratfalls that occurred in their first Phase III trial, with a batch of patients in the drug and placebo arm getting the wrong dose, 25 dropping out before the study began and 33 more unevaluable because they weren’t properly evaluated for a response — an error rate of 25% in the population.
The European regulators concluded that the clinical relevance was underwhelming with “no supportive evidence of efficacy.”
Not what you want to hear.
Nevertherless, XBiotech signaled it might appeal in CEO John Simard’s prepared response: “We are disappointed by the outcome of the meeting. We believe that the data speak in a clear and resounding voice to clinical relevance of a new antibody therapy in advanced colorectal cancer. We believe that findings from our Phase III study show that we have developed an important endpoint and methodology to evaluate anti-cancer therapy in advanced stage disease and that our monoclonal antibody represents a breakthrough treatment in patients with advanced colorectal cancer. The EMA marketing authorization application procedure enables the appeal of negative decisions from the oral explanation. We may seek access to this process at the appropriate time.”
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