Oxford, UK – 13 August 2018: Izana Bioscience, a biopharmaceutical company focused on translational medicine, today 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 randomized, 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, said: “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.”
Izana Chief Executive, Dr Someit Sidhu, said: “The start of this clinical study represents an important strategic milestone for Izana and the development of namilumab as an innovative new treatment. As a recently-launched biopharmaceutical company, Izana has ambitious plans to translate world-class science into a world-leading business, and the initiation of this study marks the beginning of that journey.”
About ankylosing spondylitis
Ankylosing spondylitis is a form of arthritis that primarily affects the spine and can lead to severe chronic pain and long-term disability. In advanced cases, new bone can form causing sections of the spine to fuse. Treatment options are limited for more advanced disease, with over half of patients not responding or not achieving remission with mainstay anti-TNFα antibody therapies. The condition is estimated to affect over four million people in major markets worldwide. As a result, the treatment market is predicted to reach over $5 billion by 2020.
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.
Launched in December 2017, Izana is a translational medicine company focused on bringing innovative science to market. Izana was founded by a team of experienced pharmaceutical industry entrepreneurs and clinicians, led by Chairman Professor Bryan Morton CBE. The Company is initially focused on the development of namilumab in ankylosing spondylitis, and its clinical development plans are supported by a £1.35 million grant from Innovate UK. Izana licensed the exclusive worldwide rights to develop, manufacture and commercialise namilumab in all indications from Takeda, which holds a strategic equity stake in the Company.
Dr Someit Sidhu
Chief Executive Officer
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*Nat Commun 2017 Nov 15;8(1):1510. doi:10.1038/s41467-017-01771-2