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XBiotech Announces First Patient Enrolled in Placebo-Controlled Clinical Study Evaluating Its anti-IL-1⍺ Therapy Bermekimab in Patients with Atopic Dermatitis (Eczema)
The study will compare three groups of patients over 16 weeks of treatment: a weekly dosing group, a biweekly dosing group, and a placebo group. Percentage of patients who achieve a 75% reduction in skin disease after 16 weeks of treatment will be the primary measure of response. The Eczema Area Severity Index (EASI) scoring system will be used to assess severity of inflammatory skin lesions. Another crucial assessment will be patient itch, which is often severe and unrelenting in this disease. A numeric rating scale (NRS) will be used to assess itch and pain at various timepoints ranging from 4-16 weeks. For more information on this study please visit www.clinicaltrials.gov.
Dr. Forman commented, “We are now understanding that IL-1alpha (IL-1⍺) plays a primary role in inflammatory skin diseases. Earlier Phase 2 results using the IL-1⍺ blocker, bermekimab, showed unprecedented treatment effects such as reduction of inflammatory lesions, itch, and pain in patients with eczema. I look forward to the outcome of this study.”
Bermekimab was previously tested in a clinical study of patients with moderate to severe AD. Those results were previously presented at the annual conferences of the
Inflammation plays a major role in the induction and progression of several skin diseases, including eczema or atopic dermatitis1. Bermekimab blocks the action of the potent inflammatory substance IL-1⍺ found in skin. It has been demonstrated that IL-1⍺ is necessary for inducing chronic skin inflammation through aberrant stores of intracellular IL-1⍺ in keratinocytes, which constitute approximately 90% of skin cells. IL-1⍺ secretion has shown not only to be necessary component in driving skin inflammation, but by itself sufficient to do so2. Therefore, neutralizing IL-1⍺ activity through an inhibitor such as bermekimab has promise to resolve chronic skin inflammation and looks to be a key target for treating atopic dermatitis, along with other inflammatory skin diseases.
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 AD3. Loss of regulation of IL-1 results in systemic inflammation with extensive skin involvement4.
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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
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. doi: 10.1002/med.21406. Epub 2016
2 Archer NK et al. Injury, dysbiosis, and filaggrin deficiency drive skin inflammation through keratinocyte IL-1a release. J Allergy Clin Immunol. 2019 Apr;143(4):1426-1443.e6. doi: 10.1016/j.jaci.2018.08.042. Epub 2018 Sep 19.
3 Han et al. Interleukin-1alpha-induced proteolytic activation of metalloproteinase-9 by human skin. Surgery. 2005 Nov;138(5):932-9.
4 Askentijevich et al. An autoinflammatory disease with deficiency of the interleukin-1-receptor antagonist. N Engl J Med. 2009
Source: XBiotech Inc.