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.

Study Chair and the Axial Spondyloarthritis Scientific Advisory Board

The clinical protocol was developed under the leadership of Study Chair Marina Magrey, M.D., and with expert guidance from a distinguished panel of SPARTAN leaders and rheumatology experts. Dr. Magrey serves as Division Chief of Rheumatology at University Hospitals Cleveland Medical Center, Professor of Medicine at Case Western Reserve University School of Medicine, and Vice-Chair of the Spondyloarthritis Research and Treatment Network (SPARTAN).