XBiotech to Launch Two Phase 2 Clinical Studies to Study Subcutaneous Administration of MABp1 for Treatment of Hidradenitis Suppurativa and Atopic Dermatitis
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.
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.
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.