Hidradenitis Suppurativa (HS) is a serious and debilitating 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 abscesses.
XBiotech recently completed an investigator sponsored randomized Phase 2 study evaluating XBiotech’s True Human antibody, MABp1, as a treatment for HS. The study met its primary endpoint, demonstrating significant improvement of HS patients compared to control after 12 weeks of therapy (Response rate of 60% vs 10%, respectively (p=0.035)).
The 20 patient double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of MABp1, the Company’s True Human antibody targeting interleukin-1 alpha (IL-1α), in patients with HS not eligible for anti-TNF therapy. Patients were randomized 1:1 to receive either MABp1 or placebo every 2 weeks for 12 weeks. Patients in the study underwent primary assessment of efficacy using Hidradenitis Suppurativa Clinical Response (HiSCR) scores at 12 weeks, continued by a follow up phase to assess time to relapse after an additional 12 weeks without therapy. Efficacy measures include assessment of HiSCR scores, a validated method for evaluating efficacy in HS patients, as well as quality of life assessment and ultrasonographic evaluation.
The results of this study have been published in the prestigious, peer-reviewed Journal of Investigative Dermatology. A link to the manuscript can be found below.
Based on the positive findings seen in the investigator initiated phase 2 study, the Company is now evaluating the subcutaneous formulation of MABp1 in a 12 week open label treatment regimen for HS in order to establish the basis for further randomized studies.
The phase 2, open label, dose escalation multicenter study will consist of two dose cohorts of MABp1 in patients with moderate to severe HS. Ten patients will receive a total of 12 weekly subcutaneous injections of MABp1 at a dose of 200mg. Following a safety assessment for patients in the first dose cohort, ten patients will receive 12 weekly subcutaneous injections of MABp1 at a dose of 400mg. 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.