FDA Clears XBiotech’s Phase II Study of Vilamakitug in 150 Axial Spondyloarthritis Patients
XBIT•XBiotech received FDA clearance for its V-SPINE IND, enabling U.S. enrollment of 150 axial spondyloarthritis patients in a Phase II trial of vilamakitug after a 30-day review without clinical hold. The randomized, placebo-controlled study will assess ASAS40 response at Week 16 with a 12-week open-label extension.
1. FDA Clearance and Enrollment Path
The FDA completed its 30-day review of XBiotech’s IND application for the V-SPINE study without imposing a clinical hold, clearing the way for U.S. patient enrollment and marking a major milestone in the company’s rheumatology program.
2. V-SPINE Phase II Protocol
The Phase II, double-blind, placebo-controlled V-SPINE trial will randomize 150 adults with active axial spondyloarthritis to receive 400 mg of vilamakitug or placebo via weekly subcutaneous injections, with ASAS40 response at Week 16 as the primary endpoint and a 12-week open-label extension.
3. Expert Advisory Panel
The clinical protocol was developed under Study Chair Marina Magrey, M.D., supported by a panel of SPARTAN rheumatology experts, bringing leadership from top institutions such as University Hospitals Cleveland and UCSF to oversee trial conduct and safety.
4. Vilamakitug’s Mechanism and Potential
Vilamakitug is a True Human™ IgG4 monoclonal antibody targeting interleukin-1α to address unmet needs in axial spondyloarthritis by potentially reducing inflammation, bone erosion and chronic pain in patients with inadequate response to existing therapies.
