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

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

AUSTIN, Texas, June 15, 2026 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) today announced that its Investigational New Drug (IND) application for V-SPINE (PT064), 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 U.S. Food and Drug Administration’s (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.