First Patient Begins Therapy with MABp1 for Treatment of Atopic Dermatitis
XBiotech Inc. (NASDAQ:XBIT) announced today that the first patient has been enrolled in its Phase 2 open label, dose escalation clinical study evaluating MABp1 in patients with moderate to severe Atopic Dermatitis (AD). The patient began treatment at Florida Academic Dermatology Center under the care of the Study’s Chair, Dr. Francisco Kerdel.
Dr. Kerdel commented, “Atopic dermatitis is a chronic inflammatory disease characterized by dry and scaly skin and severe, unrelenting itching. An inflammatory substance released by keratinocytes known as IL-1alpha, is believed to be a key trigger of inflammation in the disease. By neutralizing the activity of IL-1alpha, the new agent we are testing may arrest the disease process and offer relief from the debilitating symptoms. Today we treated a patient and I can report that within one hour of treatment, there was an unequivocal reduction in erythema [redness of the skin] and the patient reported an almost immediate reduction in associated pruritus [itching]. This is an extremely intriguing start for this promising therapy.”
John Simard, the Company’s President and CEO, added, “Interleukin-1alpha is emerging as a key therapeutic target in inflammatory skin diseases. We are extremely excited about the potential of our antibody to represent a breakthrough treatment for atopic dermatitis.”
XBiotech is developing a human-derived antibody which neutralizes IL-1 alpha (IL-1alpha), an inflammatory cytokine that plays a key role in the pathophysiology of a wide range of inflammatory skin disorder. 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 responses.
About the 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. Dose ranging in the present study will include evaluation of the Company’s new highly-concentrated subcutaneous formulation. 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.
The phase 2, open label, dose escalation, multicenter study will consist of two dose cohorts of MABp1 in patients with moderate to severe AD. Dose ranging in the present study will include evaluation of the Company’s new highly-concentrated subcutaneous formulation. 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 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-1alpha and may be a key source of inflammatory stimulus in AD. IL-1alpha is present on leukocytes, where its role in leukocyte trafficking and infiltration may represent a key step in the chronic inflammation of AD. IL-1alpha is a key inducer of matrix metalloproteinases activity which could be directly involved in the epithelial barrier breakdown in AD. Loss of regulation of IL-1 results in systemic inflammation with extensive skin involvement.
