XBiotech Inc. (NASDAQ:XBIT) announced today that it would evaluate
a new subcutaneous formulation of the Company’s True Human™
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-1⍺), 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 StudyThe 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 StudyThe 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
SuppurativaHidradenitis 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-1⍺ and may be a key source of inflammatory stimulus in AD.
IL-1⍺ is present on leukocytes, where its role in leukocyte
trafficking and infiltration may represent a key step in the
chronic inflammation of AD. IL-1⍺ 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™ Therapeutic
AntibodiesUnlike previous generations of antibody
therapies, XBiotech’s True Human™ 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™ 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
StatementsThis 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.
ContactAshley
Oteroaotero@xbiotech.com512-386-2930
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 1α, 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.
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