XBiotech Meets Primary Endpoint in Phase 2 Study of MABp1 for Treatment of Hidradenitis Suppurativa (HS)
(Thomson Reuters ONE) -
Results Demonstrate Efficacy of MABp1 as a Treatment for HS
AUSTIN, Texas, Feb. 16, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT),
developer of next-generation True Human(TM) therapeutic antibodies, today
announced topline results from an investigator sponsored randomized Phase 2
study evaluating XBiotech's True Human antibody, MABp1, as a treatment for
Hidradenitis Suppurativa (HS), a serious and debilitating chronic inflammatory
skin disorder. The study met its primary endpoint, demonstrating significant
improvement of HS patients compared to control after 12 weeks of
therapy (Response rate of 60% vs 10%, respectively (p=0.035)).
A 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.
"The overall response rate observed in the data is, in my opinion,
groundbreaking for the treatment of HS," Dr. Giamarellos-Bourboulis commented,
"I am truly encouraged by these results and very much look forward to the future
use of MABp1 as a treatment for this devastating condition." Prof. Giamarellos-
Bourboulis is supervising the Outpatients Department for HS of the
4th Department of Medicine of ATTIKON University Hospital in Greece where the
study was conducted. This center is a well-recognized European reference center
for HS with more than 20 peer-reviewed publications in the field, conduct of
four randomized trials with biological therapies and active participation in the
PIONEER studies providing registration of adalimumab for HS.
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
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 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.
Contact
Ashley Otero
aotero(at)xbiotech.com
512-386-2930
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
Unternehmensinformation / Kurzprofil:
Datum: 16.02.2017 - 17:33 Uhr
Sprache: Deutsch
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