About XBIT

Founded: 2005
Employees: 87
CEO: Sushma Shivaswamy
WebsiteView website: www.xbiotech.com

XBiotech Inc., a biopharmaceutical company, discovers, and develops, True Human monoclonal antibodies for treating various diseases. It develops a pipeline of product candidates targeting inflammatory and infectious diseases. The company is also developing interleukin-1 alpha therapies to various medical conditions, such as cancer, stroke, heart attack, or arthritis; and mediates tissue breakdown, angiogenesis, the formation of blood clots, malaise, muscle wasting, and general inflammation. The company was incorporated in 2005 and is headquartered in Austin, Texas.

Recent XBIT News & Updates

Announcement • Jun 15

XBiotech Launches Phase II Clinical Trial Evaluating Vilamakitug For The Treatment Of Active Axial Spondyloarthritis

XBiotech 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. 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. PT064 will evaluate 400 mg of vilamakitug administered as 16 weekly subcutaneous injections versus placebo in 150 adult participants with active axial spondyloarthritis (axSpA). The primary endpoint is the proportion of participants achieving an ASAS40 response at Week 16. The study also includes a 12-week open-label extension in which all participants receive vilamakitug. Despite the availability of approved biologic therapies, a substantial proportion of patients continue to experience inadequate disease control, representing a significant and persistent unmet medical need. Vilamakitug (also known as XB2001 and Natrunix™) is an IgG4 monoclonal antibody that neutralizes interleukin-1a (IL-1a), a proximal pro-inflammatory cytokine that can contribute to synovial and entheseal inflammation, osteoclast-mediated bone resorption, cartilage degradation, and inflammatory joint pain in spondyloarthritis. By targeting this upstream inflammatory mediator, vilamakitug is hypothesized to reduce both structural damage and disease activity, including in patients who have had an inadequate response to currently approved biologic therapies.

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Recent XBIT News & Updates

XBiotech Launches Phase II Clinical Trial Evaluating Vilamakitug For The Treatment Of Active Axial Spondyloarthritis

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