XBiotech Inc. (XBIT), a biopharmaceutical company, on Monday reported authorization of patient enrollment for the Phase 2 V-SPINE trial for Vilamakitug in treating active axial spondyloarthritis.
Vilamakitug (XP2001 or Natrunix) is an IgG4 monoclonal antibody neutralizing interleukin 1-alpha, a pro-inflammatory cytokine that promotes synovial and entetheseal inflammation, osteoclast-mediated bone resorption, cartilage degradation, and inflammatory joint pain in spondyloarthritis. By targeting the cytokine, vilamakitug shows potential to reduce structural damage and disease activity. The Phase 2 V-SPINE (PT064) is a planned randomized, double-blind, placebo-controlled trial, that expects to enrol 150 patients of active axial spondyloarthritis (axSpA). Patients will be administered a weekly subcutaneous injection of vilamakitug, followed by a 12-week open-label extension. The primary endpoint will be measured using the ASAS40 response at week 16.
The company submitted an investigational new drug (IND) application for vilamakitug, and successfully completed the 30-day review period without a clinical hold. The FDA granted clearance for the trial, thus enabling patient enrolment.
XBIT closed Monday at $2.35, up 0.43%.
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