XBiotech is set to go ahead with patient enrolment for the V-SPINE (PT064) Phase II clinical trial to assess the safety and efficacy of vilamakitug in adults with active axial spondyloarthritis.
This move comes following the clearance of the company’s investigational new drug application (NDA) by the US Food and Drug Administration (FDA).
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The authorisation marks the restart of XBiotech’s rheumatology programme in the US.
The placebo-controlled, double-blind trial will randomise 150 adult participants with active axial spondyloarthritis to receive either 400mg of vilamakitug via 16 weekly subcutaneous injections or placebo.
Its primary endpoint is the proportion of patients achieving an ASAS40 response at week 16.
A 12-week open-label extension phase will follow, in which all participants will be given vilamakitug.
Despite existing biologic therapies, a segment of patients experiences inadequate disease control, highlighting an ongoing unmet medical need.
The clinical protocol was developed with guidance from a scientific advisory board chaired by University Hospitals Cleveland Medical Center rheumatology division chief and Spondyloarthritis Research and Treatment Network (SPARTAN) vice-chair Dr Marina Magrey.
Vilamakitug, also known as XB2001, is a monoclonal antibody targeting interleukin-1 alpha (IL-1α), involved in spondyloarthritis-related inflammation and bone resorption.
The therapy aims to reduce structural damage and disease activity, even in patients not responding adequately to currently approved biologics.
XBiotech interim CEO and chief scientific officer Sushma Shivaswamy said: “FDA clearance of the PT064 protocol is a significant step forward for our vilamakitug programme and for patients living with axial spondyloarthritis.
“Vilamakitug is a True Human antibody indistinguishable from one naturally occurring in a healthy person with immunity to IL-1α, and we believe it represents a meaningful new approach to treating the inflammation that drives this disease.”
