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 (bermekimab), 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 bermekimab, 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 bermekimab 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 bermekimab in a 13 week open label treatment regimen for HS in order to establish the basis for further potential randomized studies.
XBiotech has launched a Phase 2, open label clinical study to evaluate bermekimab in patients with moderate to severe Hidradenitis Suppurativa (HS). The HS study will evaluate subcutaneous administered of bermekimab in a 13 week open label treatment regimen, treating both patients having failed anti-TNF treatments and those with no prior anti-TNF treatment history. There is currently an antibody therapy to block TNF. However, it is estimated that approximately 75% of patients will either fail to respond to the anti-TNF therapy or relapse after an initial response. The Company has already demonstrated in a double-blind, placebo controlled study that bermekimab, when administered as an intravenous therapy, is effective in treating patients that have failed anti-TNF therapy. The current study will evaluate whether subcutaneous administration, using pre-filled syringes, is similarly effective as bermekimab intravenous therapy. If so, the pre-filled syringe product candidate will have a beneficial impact on the convenience of the candidate therapy. If the subcutaneous therapy is found to be similarly effective, additional studies will need to be conducted to obtain marketing approval.