XBiotech Says IND Application For V-SPINE Study Completes 30-Day FDA Review Without Clinical Hold, Clearing Path For U.S. Patient Enrollment

XBiotech Launches Phase II Clinical Trial Evaluating Vilamakitug for the Treatment of Active Axial Spondyloarthritis

XBiotech announced that its IND application for the V-SPINE Phase II clinical trial evaluating vilamakitug (an IL-1α antibody) for treating active axial spondyloarthritis has completed FDA review without a clinical hold. The double-blind, placebo-controlled study will enroll 150 participants and evaluate the drug's efficacy and safety, with the primary endpoint being ASAS40 response at Week 16.