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Proof of Concept clinical trial for Izana Biosciences’ Namilumab in ankylosing spondylitis patients.

Funder InnovateUK (part of UKRI)
Recipient organisation Izana Bioscience Limited
Funding £1.3M
Period Dec 2017 — Nov 2019

In plain English

AI plain-English summary

A new antibody drug, Namilumab, is about to be tested in patients with ankylosing spondylitis, a form of arthritis that fuses the spine. This matters because current treatments fail nearly half of the roughly 4.1 million people worldwide who have the condition. Ankylosing spondylitis is three times more common in men than women, and about 45% of working-age sufferers are unemployed or have had to retire early due to the disease. Namilumab works by blocking a different immune signal than existing drugs—targeting a protein called GM-CSF rather than TNF-alpha—and has already shown promising safety and efficacy in rheumatoid arthritis trials. If this proof-of-concept trial succeeds, it would lead to a larger Phase 3 study and, eventually, market availability. For patients, that could mean a treatment option that works when current ones do not, potentially keeping more people in work and reducing the economic burden on healthcare systems. The drug is being developed by Izana Biosciences Ltd, with a target market availability date of 2022.

View original technical description
Ankylosing Spondylitis (AS) is a painful, debilitating and progressive arthritis where the joints and bones of the spine fuse together. It affects over 4.1 million people across the world, and is three times more common in men than in women. AS impacts on all aspects of the sufferer’s life, especially their ability to work and earn a living. Around 45% of sufferers of working age are unemployed or have had to retire early, imposing a high social and economic burden on healthcare providers and governments. AS is inadequately treated and almost half of patients have a poor, or no response, to current therapy. NAMILUMAB is a new monoclonal antibody with promising efficacy and safety in Rheumatoid Arthritis clinical trials. It works differently from current medicines, and there is good evidence to suggest it will provide a more effective and targeted treatment for AS sufferers. Izana Biosciences Ltd intend to progress Namilumab into a Phase 2 clinical proof-of-concept trial in AS patients. Success would herald a larger Phase 3 trial and eventual registration, and market availability in 2022.

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