XBIOTECH IN-HOUSE CLINICAL DEPARTMENT

XBiotech clinical operations are solely in house and responsible for all clinical and regulatory aspects of conducting a clinical study. With keeping clinical operations in house, the Company is able to quickly and efficiently execute studies across an array of different indications for a fraction of the cost of using Contract Research Organizations (CROs).

The team is currently contracting to provide clinical trial operation services for completion of the two ongoing Phase II clinical studies evaluating bermekimab in Hidradenitis Suppurativa and Atopic Dermatitis.

CLINICAL TEAM

The team is responsible for maintaining clinical studies throughout their entirety from pre-study preparations through database lock and study close. This includes regulatory affairs, protocol development, regulatory and IRB filings, clinical site and vendor selection and onboarding and data management.

XBiotech’s clinical team has completed numerous studies across various indications. The Company will plan future studies to develop product candidates.

CLINICAL HISTORY

 
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CLINICAL PUBLICATIONS

TO DATE THE COMPANY’S ANTI-IL-1⍺ THERAPY HAS BEEN FEATURED IN 9 PUBLICATIONS FROM 7 OF THE COMPANY’S PAST CLINICAL STUDIES.

ONCOLOGY

ONCOIMMUNOLOGY Interleukin-1 receptor antagonist levels predict favorable outcome after Bermekimab, a first-in-class true human interleukin-1α antibody, in a phase III randomized study of advanced colorectal cancer

INVESTIGATIONAL NEW DRUGS Xilonix, a novel true human antibody targeting the inflammatory cytokine interleukin-1 alpha, in non-small cell lung cancer

THE LANCET ONCOLOGY MABp1 as a novel antibody treatment for advanced colorectal cancer: a randomized, double-blind, placebo-controlled, phase 3 study

THE LANCET ONCOLOGY MABp1, a first-in-class true human antibody targeting interleukin-1α in refractory cancers: an open-label, phase 1 dose-escalation and expansion study

DERMATOLOGY

JAMA DERMATOLOGY Open-label trial of MABp1, a true human monoclonal antibody targeting interleukin 1α, for the treatment of psoriasis

JOURNAL OF INVESTIGATIVE DERMATOLOGY A Phase II Open-Label Study of Bermekimab in Patients with Hidradenitis Suppurativa Shows Resolution of Inflammatory Lesions and Pain

JOURNAL OF DRUGS IN DERMATOLOGY An open label, phase 2 study of MABp1 monotherapy for the treatment of acne vulgaris and psychiatric comorbidity

JOURNAL OF INVESTIGATIVE DERMATOLOGY MABp1 Targeting Interleukin-1Alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study

ENDOCRINOLOGY

JOURNAL OF VASCULAR SURGERY A randomized phase II study of Xilonix, a targeted therapy against interleukin 1α, for the prevention of superficial femoral artery restenosis after percutaneous revascularization

JOURNAL OF DIABETES AND ITS COMPLICATIONS Safety, pharmacokinetics, and preliminary efficacy of a specific anti-IL-1alpha therapeutic antibody (MABp1) in patients with type 2 diabetes mellitus

 
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