XBiotech Announces First Patient in Phase 2 Study Evaluating Subcutaneous MABp1 in Patients with Hidradenitis Suppurativa
July 10 2018 - 8:00AM
AUSTIN, Texas, July 10, 2018 (GLOBE NEWSWIRE) --
XBiotech Inc. (NASDAQ:XBIT) announced today that the first patient
has been enrolled in its Phase 2 open label, dose escalation
clinical study evaluating the Company's subcutaneous formulation of
MABp1 in patients with moderate to severe Hidradenitis Suppurativa
(HS). The patient began treatment at Tennessee Clinical Research
Center located in Nashville under the care of Dr. Michael Gold.
Dr. Gold commented, "We are very excited to be
participating with XBiotech in this ground breaking research
endeavor for patients suffering from hidradenitis
suppurativa. We are hopeful that this research will unlock
some of the important keys to successfully treating our
patients."
XBiotech is developing a human-derived antibody
(MABp1) which neutralizes IL-1 alpha (IL-1a), an inflammatory
cytokine that plays a key role in the pathophysiology of a wide
range of inflammatory skin disorders1. Three phase
II studies sponsored by XBiotech have been completed in
dermatologic indications (acne, psoriasis, pyoderma
gangrenosum) 2,3.
Results from an investigator sponsored phase 2 study evaluating
MABp1 for the treatment of Hidradenitis Suppurativa were published
in the Journal of Investigative
Dermatology with the study meeting its primary endpoint,
demonstrating significant improvement of HS patients treated with
MABp1 compared to control after 12 weeks of therapy (response rate
of 60% vs 10%, respectively (p=0.035)) 4,. This
previous HS study, however, involved intravenous infusion of the
antibody therapy. This will be the first use of the MABp1
subcutaneous formulation in HS, including the use of pre-filled
syringes with a newly developed concentrated formulation of MABp1
for convenient dosing.
For more information on this study, please
visit www.clinicaltrials.gov
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 abscesses5,6. Therefore,
HS is often devastating for patients with significant impact on
quality of life 7. The
Dermatology Quality Life Index (DQLI) for HS is 8.9, being higher
than any other skin disorder8. Traditional
treatments comprise of antibiotics, antiandrogens and surgery. The
global prevalence for HS is estimated at up to 4% of the
population 2.
About XBiotech
XBiotech is a fully integrated, global
biopharmaceutical company dedicated to pioneering the discovery,
development and commercialization of therapeutic antibodies.
XBiotech currently is advancing a pipeline of therapies based on
harnessing naturally occurring antibodies from patients with
immunity to certain diseases. The approach to use natural human
immunity as a source of new medicines offers the potential to
redefine the standards of care a wide range of diseases.
Headquartered in Austin, Texas, XBiotech also is leading the
development of innovative manufacturing technology to reduce the
cost and complexity of biological drug production. 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 Bou-Dargham
MJ et al. The Role of Interleukin-1 in Inflammatory and Malignant
Human Skin Diseases and the Rationale for Targeting Interleukin-1
Alpha. Med Res Rev. 2017 Jan;37(1):180-216.
2 Coleman
KM et al. Open-Label Trial of MABp1, a True Human Monoclonal
Antibody Targeting Interleukin 1a, for the Treatment of
Psoriasis. JAMA Dermatol. 2015 May;151(5):555-6.
3 Carrasco
D et al. An Open Label, Phase
2 Study of MABp1 Monotherapy for the Treatment
of Acne Vulgaris and Psychiatric Comorbidity. J Drugs
Dermatol. 2015 Jun;14(6):560-4.
4 Kanni T
et al. MABp1 Targeting Interleukin-1Alpha for Moderate to Severe
Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized
Study. J Invest Dermatol. 2017 Nov 9.
5 Revuz
J. Hidradenitis
suppurativa. J Eur Acad Dermatol
Venereol 2009; 23: 985-998.
6 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.
7 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.
8 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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Source: XBiotech, Inc via Globenewswire
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