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2016-12-06

XBiotech, Inc: XBiotech Completes Enrollment in Global Phase I/II Study for its True Human(TM) Antibody Treatment for Serious Staphylococcus aureus Infections

Study for 514G3 Antibody has Fast Track Designation by the FDAAUSTIN, Texas, Dec. 06, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT),
developer of True Human(TM) therapeutic antibodies, today announced that
enrollment has been completed in its randomized, placebo-controlled Phase
I/II study evaluating dosing, safety and efficacy of the Company's novel
antibody therapy, 514G3. This proprietary antibody therapy has received Fast
Track Designation by the FDA for the treatment of all forms of Staphylococcus
aureus
infections, including Methicillin-resistant S. aureus
(MRSA). The Company reports that top-line findings from the 514G3 study
should be reported in first quarter 2017.

"We are pleased to announce enrollment completion in this study," said Dawn
McCollough, Vice President of Clinical Operations at XBiotech. "We are
dedicated to developing this novel therapy to treat these life-threatening
bacterial infections, which affect millions of people world-wide. This is an
important milestone, bringing us one step closer to potentially addressing
the urgent need for a safe and effective S. aureus
therapy. We look forward to presenting findings from this study early next
year."

Patients enrolled in the Phase II portion of the study were randomized to
receive the highest dose of 514G3, as determined by the Phase I portion of
the study, plus standard of care antibiotics vs. placebo plus antibiotics.
Patients were treated in hospital settings at sites in the United States,
Germany, Taiwan and Korea. In addition to safety and tolerability evaluation,
the study includes efficacy measures such as time to clearance of bacteremia
(as measured by blood culture), duration of fever, serious adverse events,
length of hospitalization and survival. The randomized, blinded Phase II
portion has enrolled 36 patients, with 24 of those patients randomized to
receive 514G3.

About 514G3
514G3 was developed from a healthy human donor with natural antibodies
effective at neutralizing MRSA and non-MRSA forms of S. aureus
. 514G3 knocks out the principle immune evasion mechanism of the bacteria,
allowing white blood cells to detect and destroy the bacteria. 514G3 has
potential to treat all strains of MRSA and can be used without consideration
for strain-specific resistance to various antibiotics. As a True Human
monoclonal antibody, 514G3 is expected to be well tolerated without the side
effects or risks of antibiotics, including the lack of risk of antibiotic
resistance.

About Staphylococcus aureus

Staphylococcus aureus
(S. aureus
) is a leading cause of bacteremia and is associated with higher morbidity
compared with other pathogens. S. aureus
bloodstream infections are among the most common but also most difficult to
treat1. The incidence of S. aureus
, specifically bacteremia caused by methicillin-resistant S. aureus
(MRSA) strains, has dramatically increased in recent years in the U.S. and
parts of Europe2,3. This is partly attributable to increased resistance of
S. aureus
strains to available antibiotics. The burden of MRSA bacteremia is high with
substantial costs and resources for healthcare systems4. Therefore, there
remains an urgent need for new treatment approaches.

About True Human(TM) Therapeutic Antibodies
Unlike previous generations of antibody therapies, XBiotech's True Human(TM)
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(TM) 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.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements, including declarations
regarding management's beliefs and expectations that involve substantial
risks and uncertainties. In some cases, you can identify forward-looking
statements by terminology such as "may," "will," "should," "would," "could,"
"expects," "plans," "contemplate," "anticipates," "believes," "estimates,"
"predicts," "projects," "intend" or "continue" or the negative of such terms
or other comparable terminology, although not all forward-looking statements
contain these identifying words. Forward-looking statements are subject to
inherent risks and uncertainties in predicting future results and conditions
that could cause the actual results to differ materially from those projected
in these forward-looking statements. These risks and uncertainties are
subject to the disclosures set forth in the "Risk Factors" section of certain
of our SEC filings. Forward-looking statements are not guarantees of future
performance, and our actual results of operations, financial condition and
liquidity, and the development of the industry in which we operate, may
differ materially from the forward-looking statements contained in this press
release. Any forward-looking statements that we make in this press release
speak only as of the date of this press release. We assume no obligation to
update our forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press release.

1 Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB.
Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases
from a prospective nationwide surveillance study. Clin Infect Dis 2004;
39:309-17.

2 Steinberg JP, Clark CC, Hackman BO. Nosocomial and community acquired
Staphylococcus aureus bacteremias from 1980 to 1993: impact of intravascular
devices and methicillin resistance. Clin Infect Dis 1996; 23:255-9.

3 EARSS management team. European Antimicrobial Resistance Surveillance System
annual report 2006. Bilthoven, The Netherlands: National Institute for Public
Health and the Environment, 2007.

4 Shorr AF, Lodise T. Burden of methicillin-resistant Staphylococcus aureus on
healthcare cost and resource utilization. ISMR Update 2006; 1:4-11.

Contact
Ashley Otero
aotero@xbiotech.com
512.386.2930

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This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: XBiotech, Inc via Globenewswire

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