XBiotech, Inc: XBiotech Announces Publication of Phase 2 Data from Hidradenitis Suppurativa Phase 2 Study in The Journal of Investigative Dermatology

Report Highlights Efficacy of anti-IL-1 alpha Antibody Therapy in the Treatment
of the Debilitating Skin Disease, Hidradenitis Suppurativa 

AUSTIN, Texas, 2017-12-04 14:00 CET (GLOBE NEWSWIRE) --
XBiotech Inc. (NASDAQ:XBIT) announced today the publication of data from its
randomized phase 2 study evaluating XBiotech's True Human antibody, MABp1, as
a treatment for Hidradenitis Suppurativa (HS). The results have been published
online as an article in press in the prestigious, peer-reviewed Journal of
Investigative Dermatology in a manuscript titled, "MABp1 Targeting
Interleukin-1alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible
for Adalimumab: A Randomized Study." The article is planned to be featured in
an upcoming print issue of the journal. 

"This study features not only the clinical efficacy of MABp1 but also
demonstrates its mechanism of action, which is something that is truly unique
for a candidate drug treatment for HS," commented Prof. Evangelos
Giamarellos-Bourboulis, M.D., Ph.D., who supervises the Outpatients Department
for HS of the 4th Department of Medicine at Attikon University Hospital in
Greece where the featured study was conducted and also served as the Principal
Investigator of the study. He further stated, "MABp1 represents a potential
breakthrough in the treatment of HS as it could cover an overtly unmet need for
patients either failing or not eligible for adalimumab, the only registered
biological treatment of HS to date. Data acquired by this study shed light to
the promising efficacy of MABp1 even for naïve patients." 

The publication highlights the efficacy of MABp1, in which the study's primary
endpoint was met in 60% of MABp1 treated patients compared to 10% of placebo
patients (odds ratio 13.50, 95% confidence intervals 1.19-152.51; p=0.035). The
clinical efficacy of MABp1 was maintained until week 24 (12 weeks after
discontinuation of treatment) at which time point, no patients treated with
placebo had a positive HiSCR score (0%) compared to four out of 10 patients
(40%) treated with MABp1. Treatment with MABp1 was also accompanied by better
patient-reported outcomes. Decrease of the visual analogue scale (VAS) was
found in 30% of placebo patients compared with 70% of patients treated with
MABp1. 

About the Study
The 20-patient double-blind, placebo-controlled study was designed to evaluate
the safety and efficacy of MABp1, the Company's True Human antibody targeting
interleukin-1 alpha (IL-1a), in patients with HS not eligible for anti-TNF
therapy. Patients were randomized 1:1 to receive either MABp1 or placebo every
2 weeks for 12 weeks. Patients in the study underwent primary assessment of
efficacy using Hidradenitis Suppurativa Clinical Response (HiSCR) scores at 12
weeks, continued by a follow up phase to assess time to relapse after an
additional 12 weeks without therapy. Efficacy measures include assessment of
HiSCR scores, a validated method for evaluating efficacy in HS patients, as
well as quality of life assessment and ultrasonographic evaluation. 

About Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin disorder
affecting areas rich in apocrine glands. Nodules appear in the affected areas
and progressively become swollen with spontaneous rupture and release of pus.
This process occurs repeatedly leading to formation of deep sinus tracts and
painful dermal abscesses 1,2. Therefore, HS is often devastating for patients
with significant impact on quality of life 3. The Dermatology Quality Life
Index (DQLI) for HS is 8.9, being higher than any other skin disorder 4.
Traditional treatments comprise of antibiotics, antiandrogens and surgery. The
global prevalence for HS is estimated at up to 4% of the population 2. 

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. 

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,"
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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 Revuz J. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009; 23:
985-998. 
2 Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive
review. J Am Acad Dermatol. 2009 Apr;60(4):539-61; quiz 562-3. doi:
10.1016/j.jaad.2008.11.911. 
3 Vasquez BG, Alikhan A, Weaver, AL, et al. Incidence of hidradenitis
suppurativa and associated factors: a population-based study of Olmsted County,
Minnesota. J Invest Dermatol. 2013 Jan;133(1):97-103. doi:
10.1038/jid.2012.255. Epub 2012 Aug 30. 
4 Révuz JE, Canoui-Poitrine F, Wolkenstein P, et al. Prevalence and factors
associated with hidradenitis suppurativa: results from two case-control
studies. J Am Acad Dermatol 2008; 59: 695-701. 

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