XBiotech to Launch Two Phase 2 Clinical Studies to Study
Subcutaneous Administration of MABp1 for Treatment of Hidradenitis
Suppurativa and Atopic Dermatitis
AUSTIN, Texas, April 16, 2018
(GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today
that it would evaluate a new subcutaneous formulation of the
Company's True Human(TM) monoclonal antibody, MABp1, in two
separate Phase 2, open label, dose escalation studies in patients
with moderate to severe Atopic Dermatitis (AD) and Hidradenitis
Suppurativa (HS). The Company is conducting final preparations for
study launch including the first clinical site initiation scheduled
later this month.
Francisco Kerdel, M.D., founder of
Florida Academic Dermatology Centers and the Study Chair for the
Atopic Dermatitis study, commented, "The antibody targeting
Interleukin-1 alpha represents potentially a new era in the
management of inflammatory skin disorders. MABp1 is a
first-of-its-kind being isolated from a human immunoregulatory
response that blocks inflammation. New therapies are needed and we
are excited about the potential for MABp1 in the clinic."
Alice Gottlieb, M.D., Ph.D.,
Professor of Dermatology at New York Medical College and Study
Chair for the Hidradenitis Suppurativa study, commented, "We need
new targets for therapies for Hidradenitis Suppurativa (HS).
The development of adalimumab, a TNF blocker, for HS represented a
major advance, however, patients still experience inadequate
responses. Targeting IL-1 alpha with the monoclonal
antibody MABp1 may provide more complete clinical responses
and new hope for patients suffering with HS."
MABp1 is a human-derived antibody
which targets and 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) as
well as one investigator sponsored study in Hidradenitis
Suppurativa. In these studies, MABp1 was well tolerated and showed
good therapeutic responses2,3,4. Dose
ranging of the Company's new subcutaneous formulation for MABp1 is
planned to be studied in 4 week and 12 week open label treatment
regimens for AD and HS. These findings will establish the basis for
further randomized studies with the subcutaneous formulation.
HS Study
The phase 2, open label, dose escalation multicenter study will
consist of two dose cohorts of MABp1 in patients with moderate to
severe HS. Patients entering the study will not have received any
previous approved biological therapies for the treatment of HS. Ten
patients will receive a total of 12 weekly 200mg subcutaneous
injections of MABp1. Following a safety assessment for patients in
the first dose cohort, ten patients will receive 12 weekly 400mg
subcutaneous injections of MABp1. Patients will be followed for 12
weeks to allow for assessment of safety and preliminary efficacy.
Various efficacy measures will be assessed including: Hidradenitis
Suppurativa Clinical Response (HiSCR) from baseline to 12 weeks,
changes in patient reported outcomes from baseline to week 12
including Dermatology Life Quality Index (DLQI), Visual Analog
Scale (VAS) for disease and VAS for pain, assessment of Physician's
Global Assessment (PGA), Disease Severity Score and modified
Sartorius score at week 12, and change in inflammatory lesion
count.
AD Study
The phase 2, open label, dose escalation multicenter study will
consist of two dose cohorts of MABp1 in patients with moderate to
severe AD. Ten patients will receive a total of 4 weekly 200mg
subcutaneous injections of MABp1. Following a safety assessment for
patients in the first dose cohort, ten patients will receive 4
weekly 400mg subcutaneous injections of MABp1. Patients will be
followed for 6 weeks to allow for assessment of safety and
preliminary efficacy. Various efficacy measures will be assessed
including changes in Eczema Area and Severity Index Score (EASI),
Dermatology Life Quality Index (DLQI), Patient Oriented Eczema
Measure (POEM) and SCORing Atopic Dermatitis (SCORAD), a measure of
disease severity in AD.
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 Atopic
Dermatitis
Atopic dermatitis (AD) is an inflammatory skin disease affecting as
much as 20% of the population in western industrial societies.
Chronic eczema in AD and associated pruritus can be a significant
cause of morbidity and impact life quality. Disease pathogenesis is
complex but ultimately converges on a pathological inflammatory
process that disrupts the protective barrier function of the skin.
Keratinocytes are a major reservoir of IL-1A and may be a key
source of inflammatory stimulus in AD. IL-1A is present on
leukocytes, where its role in leukocyte trafficking and
infiltration may represent a key step in the chronic inflammation
of AD. IL-1A is a key inducer of matrix metalloproteinases
activity which could be directly involved in the epithelial barrier
breakdown in AD9. Loss of
regulation of IL-1 results in systemic inflammation with extensive
skin involvement10.
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
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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 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.
3 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.
4 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.
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.
9 Han et
al. Interleukin-1alpha-induced proteolytic activation of
metalloproteinase-9 by human skin. Surgery. 2005
Nov;138(5):932-9.
10 Askentijevich
et al. An autoinflammatory disease with deficiency of the
interleukin-1-receptor antagonist. N Engl J Med. 2009 Jun
4;360(23):2426-37.