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Bermekimab Successfully Treats Hidradenitis Suppurativa, Including Significant Reduction in Pain
XBiotech (NASDAQ: XBIT) announced the successful outcome of its multicenter, open label, confirmatory study using bermekimab to treat patients with moderate to severe Hidradenitis Suppurativa (HS). As quoted in the press release: 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 …
XBiotech (NASDAQ: XBIT) announced the successful outcome of its multicenter, open label, confirmatory study using bermekimab to treat patients with moderate to severe Hidradenitis Suppurativa (HS).
As quoted in the press release:
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 in HS using bi-weekly, intravenous infusions of bermekimab in which safety and primary efficacy endpoints were met. The present study, which tested a new concentrated 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.
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