XBiotech Inc (XBIT) News & EventsXBITNews & EventsXBiotech Inc

XBiotech's V-SPINE Clinical Trial Approved by FDA

XBiotech announced that its investigational new drug, or IND, application for V-SPINE, a Phase II, double-blind, placebo-controlled, randomized study evaluating the efficacy and safety of vilamakitug in participants with active axial spondyloarthritis, has successfully completed the FDA 30-day review period without a clinical hold. The study is now authorized to proceed with patient enrollment in the United States, marking the resumption of XBiotech's rheumatology program.

XBiotech pauses rheumatology program

XBiotech is halting its clinical program in rheumatological disease while it seeks to understand the outcome from its recently completed Phase II, Double-Blind, Placebo-Controlled, Randomized study in Rheumatoid Arthritis. The Phase II study failed to meet its primary endpoint amid substantial irregularities that make unequivocal interpretation of the findings difficult. XBiotech was planning launch of additional studies in arthritis as well as other areas of rheumatology, including ankylosing spondylitis, which are now on hold while recent findings are evaluated. About 230 subjects with moderate to severe rheumatoid arthritis were enrolled into the Phase II arthritis study, which examined the Company's candidate drug, Natrunix, in combination with methotrexate. The study's primary endpoint was the American College of Rheumatology 20 response rate after 12 weeks of treatment. Various other rheumatological assessments were also performed, including NRS-pain scores, arthritic joint counts, quality of life assessments, and safety. The study population was randomized into three groups in a 1:1:1 ratio: 200 mg or 400mg Natrunix weekly in combination with MTX; or placebo weekly with MTX. Irregularities in the Phase II study involved the highest enrolling clinical sites, including numerous subjects being enrolled multiple times. Although the study did not meet efficacy endpoints, discrepancies found during data analysis suggest caution in interpreting results. Findings of the study are still being analysed in order to better understand the implications of the findings and determine how these results can be used to guide potential further rheumatology studies for Natrunix.