As reported in StreetInsider, XBiotech (NASDAQ: XBIT) announced today the successful outcome of its multicenter, open label, confirmatory study using bermekimab to treat patients with moderate to severe Hidradenitis Suppurativa (HS). Primary and key secondary endpoints were met in this study with significant, differentiating findings. The company previously published data from its double-blind, placebo-controlled study on HS, using bi-weekly, intravenous infusions of bermekimab, in which safety and primary efficacy endpoints were met. The present study, which tested a new concentration of subcutaneous formulation in a convenient pre-filled syringe, confirmed and expanded upon the previous findings.
The present study enrolled 42 patients, each receiving 400mg subcutaneous weekly doses of bermekimab in a 12-week treatment regimen. There were two treatment groups of subjects: those who had failed prior anti-TNF therapy (n=24); and those with no prior anti-TNF treatment history (n=18). The study was conducted at eleven different dermatology research centers across the U.S..
Bermekimab was well-tolerated with no safety concerns. Statistically significant improvement was seen for efficacy endpoints in both anti-TNF and anti-TNF naïve groups, including the Hidradenitis Suppurativa Clinical Response Score (HiSCR); Dermatology Life Quality Index (DLQI); Physician’s Global Assessment (PGA); change in inflammatory lesion count; Disease Activity Score (DAS); and Visual Analogue Scales (VAS) for Disease Impression and Pain. These efficacy findings differentiate bermekimab from the available treatments for HS.