XBiotech announces first patient enrolled in study evaluating bermekimab
XBiotech announced that the first patient was enrolled in its randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating bermekimab in patients with moderate to severe Hidradenitis Suppurativa. The multi-center, international study will enroll approximately 150 patients into three arms: two bermekimab dosing regimens versus a placebo arm over sixteen weeks of therapy. The study is chaired by renowned investigative dermatologist Alice Gottlieb, MD, PhD, Medical Director of dermatology at the Mount Sinai Beth Israel Campus and Clinical Professor at the Icahn School of Medicine at Mount Sinai. The study's primary endpoint is the percentage of subjects achieving Hidradenitis Suppurativa Clinical Response at week 12. Multiple secondary efficacy endpoints will be assessed after 12 and 16 weeks of therapy, including: Numerical Rating Scale for pain and itch; Modified Sartorius Score; Dermatology Life Quality Index; Hospital Anxiety and Depression Scale; and Patient Global Impression of Change and Severity. Bermekimab has demonstrated its safety and efficacy treating HS in two previous clinical studies. A recent open label study demonstrated that weekly bermekimab is an effective therapy, as measured by improvement in disease according to HiSCR, the key measure of disease in HS. In the study, 61% of patients with no prior biological therapy achieved positive HiSCR at 12 weeks1, and 63% of patients who had failed previous biological therapy achieved a positive HiSCR at 12 weeks. Another unrivaled finding in the study was a significant treatment-related reduction of pain in HS patients. Reducing pain is widely recognized among experts as a key objective for HS treatment, but this symptom has been largely unaddressed by available drugs. Pain was assessed with a patient questionnaire using a numerical rating scale from 0 to 10. A 30% and greater than or equal to1-unit reduction in pain score is considered a clinically important relief from pain, and no approved monotherapy for HS has elicited a clinically significant effect on pain. Remarkably, a substantial majority of patients treated with weekly bermekimab achieved this endpoint: 67% and 72% at week 12 who had prior or no prior anti-TNF therapy, respectively. An earlier double-blind, placebo controlled, randomized study also evaluated bermekimab in the treatment of HS. The study met its primary endpoint, demonstrating significant improvement of HiSCR in patients treated with bermekimab compared to control after 12 weeks of therapy.