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Actionable news in XBIT: XBiotech Inc,

Xbiotech: 'On The Doorstep To Market'

Summary

Lead product candidate Xilonix is being reviewed for marketing authorization in an Accelerated assessment by the European Medical Agency (EMA).

FDA fast tracked Phase III global study for Xilonix to be completed by the end of 2016.

FDA fast tracked study for the treatment of serious infections due to S. aureus, incl. MRSA, has advanced into Phase II.

Extended production facility to be completed in 2nd-half 2016.

Short squeeze ahead?

Xbiotech has delivered on major milestones ahead of time

Following my last article on Xbiotech (NASDAQ:XBIT), Aug 17, 2015, Xbiotech has advanced its business in several aspects and is closer than ever to receive marketing authorization in Europe for its lead product candidate Xilonix. The EMA (European Medical Agency) has recently granted Xbiotech Accelerated review for its new drug application, allowing marketing authorization to be due in Q3 2016 - press release, business update.

Xilonix Europe - EMA accelerated review

Only five months ago Xbiotech has announced positive results in European Phase III study for its breakthrough therapy for colorectal cancer. Patients were assessed for responders using improved lean body mass (LBM) and EORTC performance as co-primary endpoints - a novel design established in collaboration with the EMA. Although the company reported a flub in November with some of the patients, it still had 333 evaluable patients to conduct a responder analysis. Out of these patients 33% randomized to Xilonix met both co-primary endpoints vs. only 19% in the placebo group plus BSC. Further to this, the company reported in their recent business update call that there was a 76% relative improvement in objective response rate for patients receiving Xilonix. Patients receiving the antibody vs. placebo were 53% more likely to have stable disease and a 26% reduction of serious adverse events (SAEs). On the basis of these results, Xbiotech has been granted accelerated review by the EMA. According to the Guidelines of the EMA, Accelerated review is only granted for"… medical products for human use which are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation…". In this case it's hard for me to imagine that the EMA will not grant the approval. Xbiotech has especially designed this trial with its novel primary endpoints together with the EMA and now received an accelerated review. Anything else would be a big surprise.

514G8 for S. aureus - FDA Fast track

Xbiotech also advanced to the Phase II of the clinical study with the highest dose of its antibody 514G8 for treating serious infections due to S. aureus, including Methicillin-resistant S. aureus (MRSA) - yet an unmet medical need - after having no dose limiting toxicities in the Phase I portion of the study. The 2:1 randomized Phase II portion will enroll 36 patients across approximately 16 clinical sites in the United States. The findings of the Phase I portion show a reduction of 50% in SAEs compared to placebo. SAEs were defined in the study as an event that was life threatening or resulted in prolongation of hospitalization or death . The Food and Drug Administration (FDA) has granted another Fast Track designation to Xbiotech for this.

Xilonix US- FDA Fast track

Also the other Fast-tracked FDA Phase 3 global study for treatment of metastatic...


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