XBiotech Announces Publication of Phase 2 Data from Hidradenitis Suppurativa Phase 2 Study in The Journal of Investigative De...
December 04 2017 - 8:00AM
YASTEST
Report Highlights Efficacy of anti-IL-1 alpha
Antibody Therapy in the Treatment of the Debilitating Skin Disease,
Hidradenitis Suppurativa
AUSTIN, Texas, Dec. 04, 2017 (GLOBE NEWSWIRE) --
XBiotech Inc. (NASDAQ:XBIT) announced today the publication of data
from its randomized phase 2 study evaluating XBiotech's True
Human(TM) 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-1alpha), 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(TM) Therapeutic
Antibodies
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.
Contact
Ashley Otero
aotero@xbiotech.com
512-386-2930
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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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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