UK-based biopharmaceutical company Izana Bioscience has commenced a phase II proof-of-concept clinical study of namilumab in ankylosing spondylitis.
Ankylosing spondylitis is a painful and progressive type of arthritis, in which some or all of the joints and bones of the spine fuse together.
The disease is more progressive in the second decade of life with symptoms such as back pain and stiffness.
Namilumab is a human monoclonal antibody targeting granulocyte macrophage-colony stimulating factor (GM-CSF).
The antibody has showed efficacy in a phase II trial carried out in more than 100 rheumatoid arthritis patients and it was well tolerated in earlier clinical studies.
The study principal investigator Peter Taylor said: “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.”
The company will recruit more than 40 patients with moderate-to-severe ankylosing spondylitis in the randomized, double-blind and placebo-controlled namilumab in ankylosing spondylitis therapy (NAMASTE) at 10 specialist centers in the UK.
Izana intends to present the results from the study in early 2019.
The study, which will carry out in the UK, will demonstrate the efficacy of namilumab as measured by changes in clinical symptoms, markers of inflammation and MRI appearance of the spine.
Izana chief executive 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.”
Founded in December 2017, Izana is a translational medicine company initially focusing on the development of namilumab in ankylosing spondylitis. Its clinical development plans are supported by a £1.35m grant from Innovate UK.
The company has secured the exclusive worldwide rights to develop, manufacture and commercialise namilumab in all indications from Takeda, which has an equity interest in the company.