XBiotech Inc. (NASDAQ:XBIT) today announces rapid enrollment in its randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating bermekimab in patients with moderate to severe Hidradenitis Suppurativa (HS). 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) and will enroll approximately 150 patients. XBiotech announced the first patient enrolled in the study on October 23, 2019. Today, XBiotech is already updating status of the study, reporting that 51 patients have now been randomized, or assigned to an investigational arm of the study.
Dr. Gottlieb commented, “The very strong participation by clinical sites and by patients is indicative of the substantial need for new therapy and of the favorable view of bermekimab.”
Ms. Ashley Otero, XBiotech’s Director of Clinical Operations, stated, “We are extremely excited about the robust enrollment seen to date. After only a few weeks since enrollment of the first patient, we have already randomized over one-third of the intended study population. If this pace continues, we will complete enrollment well ahead of our anticipated timing.”
Bermekimab has been tested in two previous clinical studies. In a recent open label study (n=42), 61% of patients with no prior biological therapy and 63% of patients who had failed previous biological therapy (i.e. adalimumab) achieved a positive HiSCR at 12 weeks. Additionally, the majority of patients in both groups achieved clinically significant reduction in pain from their disease. These results were presented at the American Academy of Dermatology (AAD) in 2019.
In an earlier double-blind, placebo controlled, randomized study which also evaluated bermekimab in the treatment of HS, the study’s primary endpoint was met, demonstrating significant improvement of HiSCR in patients treated with bermekimab compared to control after 12 weeks of therapy (response rate of 60% vs 10%, respectively (p=0.035)). These results have been published in a leading peer reviewed medical journal, the Journal of Investigative Dermatology1.
The primary endpoint for the current study is the percentage of subjects achieving a 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.