XBiotech's worst fears come true as EMA rejects colorectal cancer drug

CHMP is unimpressed with the clinical data and has concerns about the manufacturing of Xilonix.

The EU's drug review committee followed through on an earlier warning and rejected XBiotech's metastatic colorectal cancer candidate Xilonix, extinguishing the company's last hope of a positive outcome for its lead drug application.

Undeterred, XBiotech said in an SEC filing that it plans to file a request for the Committee for Medicinal Products for Human Use (CHMP) to look again at the dossier for the drug as it "believes it has a strong position for re-examination."

XBiotech is developing Xilonix, a monoclonal antibody targeting interleukin-1 alpha, to treat the debilitating symptoms seen in patients with advanced colorectal cancer, such as muscle wasting (cachexia).

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The CHMP is just as vehement as the biotech in its rejection of the drug, however, citing "a number of concerns," including that XBiotech's main trial "did not show clear improvements in either lean body mass or quality of life." It also said patients on XBiotech's candidate had a greater risk of infections, "which was not considered acceptable in vulnerable patients who will be receiving palliative care."

As if that weren't enough, the EU panel also has concerns about the production process for the drug, saying it wasn't satisfied that the controls were in place to make sure the medicine would have the same quality as the product used in clinical trials.

Shares in XBiotech have been in the doldrums since the prospects of a positive outcome for Xilonix started to wane last year, and the company looks set for a stormy ride today, falling more than 10% in premarket trading.

Despite what has been described as a catalog of errors in its main clinical trial—which was carried out at a single site in Poland—XBiotech was talking up the prospects for Xilonix as recently as last month, saying it was "confident it has addressed all outstanding issues raised in the application."

The company has a second phase 3 trial in play in the U.S. which according to clinicaltrials.gov is due to generate results in the near future.

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