Phase II proof-of-concept clinical study of Namilumab for ankylosing spondylitis initiated


namilumabIzana Bioscience, a biopharmaceutical company focused on translational medicine, has announced the initiation of a phase II proof-of-concept clinical study of namilumab in ankylosing spondylitis, a debilitating arthritic disease of the spine that affects millions of people worldwide.

The randomised, double-blind, placebo-controlled NAMASTE study (Namilumab in Ankylosing Spondylitis Therapy) will enrol over 40 patients with moderate-to-severe ankylosing spondylitis at 10 specialist centres in the UK.  Study results are expected in early 2019.

Principal investigator, Peter Taylor, Norman Collinson professor of Musculoskeletal Sciences, University of Oxford, UK, says: “I am delighted to be part of the team developing this innovative new therapy targeting ankylosing spondylitis.  The condition can be devastating, and for many patients with more advanced disease current treatments are often ineffective.  With new research indicating namilumab targets a key pathway in ankylosing spondylitis, I am excited at the prospect of exploring its potential to become an effective new therapy for this greatly underserved condition.”

Currently, treatment options for more advanced ankylosing spondylitis are limited, with only one third of patients achieving disease remission with mainstay TNF inhibitor therapies; therefore, a significant unmet clinical need remains, as reported in Nature Communications. The condition is estimated to affect over four million people in major markets worldwide, and the prevalence of spondyloarthritis as reported in the literature is at least 0.5% in European and US populations.

Namilumab is a human monoclonal antibody targeting granulocyte macrophage-colony stimulating factor (GM-CSF).  The antibody has demonstrated efficacy in a phase II trial conducted in over 100 rheumatoid arthritis patients, and has been well tolerated in previous clinical studies.  Recently published research indicates GM-CSF is a highly promising target for ankylosing spondylitis therapeutics.


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