AUSTIN, Texas, Feb. 22, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT ) announced that all subjects have been dosed in its pharmacokinetic (PK) study evaluating MABp1 half-life in healthy volunteers. This Phase I study will provide further PK data and will enable additional characterization of the PK of MABp1 at a 7.5mg/kg IV dose. Safety and tolerability will also be assessed. PK analyses at various time points ranging from pre-infusion to 336 hours post infusion will be collected. The study is on schedule to be completed as planned for the Company’s upcoming regulatory submission.
The Company previously reported it had been granted an additional 30 days to submit its responses to the Day 180 List of Outstanding Issues (D180LOI) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in connection with the Company’s Marketing Authorization Application for Xilonix. This extension was granted as a result of a clarification meeting held recently between XBiotech and the EMA. The extension was granted in order to allow sufficient time for the Company to complete the PK study in healthy subjects. These new PK data are intended to address relevant technical questions in the D180LOI and will be included in the Company’s response submission scheduled for March 22nd.
“We are happy to report the expeditious execution of this study, which will provide further PK data at multiple time points in the first 96 hours after dosing. This will enable additional and accurate characterization of the peak concentration, half-life and clearance, thus confirming PK is consistent with what would be expected from a monoclonal antibody,” commented Michael Stecher, XBiotech’s Medical Director. He further stated, “With these additional data in hand, we look forward to fully addressing the complete list of day 180 questions in March.”
About True Human™ Therapeutic Antibodies XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
About XBiotech XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com .
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Contact Ashley Otero aotero@xbiotech.com 512-386-2930
