XBiotech Completes Dosing of Subjects in PK Study Being Conducted in Connection with European Marketing Application
February 22 2017 - 8:00AM
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
AntibodiesXBiotech’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
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