XBiotech presents Phase 2 bermekimab data

XBiotech released findings for its Phase 2 clinical study for bermekimab presented at the American Academy of Dermatology’s annual meeting The company provided the results for 42 Hidradenitis Suppurativa, or HS, patients that received 12 weekly injections of bermekimab therapy. Aside from “excellent” safety, a major finding of the study was that patients achieved significant therapeutic benefit from bermekimab therapy regardless of whether or not they had previously failed treatment with the only existing FDA-approved biological drug treatment for HS. In what the company believes to be a breakthrough for the disease, patients having previously failed as well as those who never received anti-TNF therapy had significant reduction in pain. Pain is a hallmark of HS that has so far not been adequately addressed by any therapy. Data showed that by week 12 of treatment, 63% of patients who have previously failed anti-TNF therapy achieved a positive HiSCR; similarly, 61% of patients with no prior anti-TNF therapy achieved positive HiSCR. These results translated into a 46% and 60% reduction in the number of abscesses and inflammatory nodules, respectively, for the two groups. A breakthrough finding was that 67% and 72% of patients achieved a clinically meaningful reduction in pain by week 12.The existing FDA-approved biological therapy was only shown to reduce pain when used in combination with oral antibiotic. No antibiotics were used as part of the clinical study with bermekimab. The study enrolled 42 patients, each receiving 400mg subcutaneous weekly doses of bermekimab in a 12-week treatment regimen. There were two treatment groups: those who had failed prior anti-TNF therapy and those with no prior anti-TNF treatment history. The study was conducted at eleven different dermatology research centers across the U.S. An intravenous infusion formulation of bermekimab was previously used in a randomized, double-blind, placebo controlled Phase 2 study for patients with HS, where bermekimab treated patients had a significantly higher rate of HiSCR compared to placebo. However, this was the first study of bermekimab in HS using a new subcutaneous formulation that is administered from pre-filled syringes. XBiotech invested in new filling equipment and developed the pre-filled syringe manufacturing process to provide a more convenient subcutaneous bermekimab product candidate.
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