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XBiotech Announces First Patient Enrolled in Randomized Multi-Center Clinical Study Evaluating Bermekimab Therapy in Patients with Hidradenitis Suppurativa
AUSTIN, Texas, Oct. 23, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today that the first patient was enrolled in its randomized,
About this update from Xbiotech Inc.
[{"type":"text","content":"AUSTIN, Texas, Oct. 23, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today 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 (HS). The multi-center, international study will enroll approximately 150 patients into three arms: two bermekimab dosing regimens versus a placebo arm over sixteen (16) 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.\n The study’s primary endpoint is the percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12. Multiple secondary efficacy endpoints will be assessed after 12 and 16 weeks of therapy, including: Numerical Rating Scale (NRS) for pain and itch; Modified Sartorius Score; Dermatology Life Quality Index (DLQI); Hospital Anxiety and Depression Scale (HADS); and Patient Global Impression of Change and Severity (PGI-c, PGI-s). Please visit www.clinicaltrials.gov for a more complete description of the study. Dr. Gottlieb commented, “With bermekimab we now have a potential new tool in the toolbox to treat diseases like hidradenitis suppurativa. Targeting IL-1⍺ represents a new class of medication. I am pleased that we are underway with a large randomized study that we can expect will provide definitive findings for this novel therapy.” John Simard, XBiotech CEO, stated, “HS is a cornerstone for our bermekimab dermatology franchise. We are excited to launch this large randomized study. We expect this study will corroborate the promising safety and efficacy results seen in our previous clinical trials of bermekimab to treat HS, including rapid and dramatic reduction of pain. Our True Human antibody platform harnesses the human body’s natural antibody response to disease, and we hope that in the case of HS, bermekimab will offer an effective, safe relief to people with this difficult condition.” 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...