YASTEST
Open Label Extension Results, which Demonstrate
Significant Improvements in HS Patients Previously Treated with
Placebo, will be Presented at the 7th Conference of the European
Hidradenitis Suppurativa Foundation (EHSF)
AUSTIN, Texas, Jan. 19, 2018 (GLOBE NEWSWIRE) --
XBiotech Inc. (NASDAQ:XBIT) announced today that results from an
open label extension (OLE) phase of the randomized Phase 2 study
evaluating XBiotech's True Human(TM) antibody, MABp1, as a
treatment for Hidradenitis Suppurativa (HS), will be presented at
the European Hidradenitis Suppurativa Foundation (EHSF) Conference
occurring in Rotterdam Netherlands February 7-9th. The
oral presentation titled, "An open-label extension
study of MABp1 targeting interleukin-1alpha for hidradenitis
suppurativa (HS)" will be given by Theodora Kanni, M.D., Ph.D.,
Attikon University Hospital in Athens Greece, on 8 February 2018
between 1:50 and 2:50pm local time.
The findings being presented come from patients
that had received placebo in a previous Phase 2 double-blind,
placebo-controlled study. Patients that had originally been
allocated to placebo in the Phase 2 study were allowed to receive
treatment with the MABp1 antibody therapy in a so called open label
extension (OLE) study. Seven of 10 patients that had originally
received placebo were treated with MABp1 for 12 weeks. Main
endpoints used in the OLE included safety and HiSCR score at the
end of the 12 week treatment. At the conclusion of the
double-blinded study, only one patient (1 of 10, or 10%) receiving
placebo had achieved HiSCR. During the OLE, five patients (5 of 7,
or 71.4%) achieved the HiSCR response (p=0.035). There was a total
of 24 HS exacerbations during the blinded portion of the study
compared to just 1 exacerbation during the OLE phase.
Prof. Evangelos Giamarellos-Bourboulis, M.D.,
Ph.D., who supervises the Outpatients Department for HS of the
4th Department
of Internal Medicine at Attikon University
Hospital in Athens, Greece where the study was
conducted and also served as the Principal Investigator of the
study, commented, "Results of the OLE crossover study provide
further compelling evidence of the activity for MABp1 in HS. We
will work diligently to expand this work and avail this treatment
to patients in need."
Results of the Phase 2 study were recently
published in the Journal of Investigative Dermatology,
reporting that the study met its primary endpoint and demonstrated
a significant improvement in HS patients treated with MABp1
compared to control after 12 weeks of therapy (Response rate
of 60% vs 10%, respectively (p=0.035)). 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
included 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 abscesses1,2. Therefore,
HS is often devastating for patients with significant impact on
quality of life3.
The Dermatology Life Quality Index (DLQI) for HS is 8.9, being
higher than any other skin disorder4. Traditional
treatments comprise of antibiotics, antiandrogens and surgery.
Prevalence rates for HS have been estimated at up to 4%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.
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
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information contained therein.
Source: XBiotech, Inc via Globenewswire
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