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.