Izana starts proof-of-concept trial for spinal arthritis drug

U.K. startup Izana has started recruiting patients into its phase 2a trial of its anti-GM-CSF antibody namilumab in ankylosing spondylitis, a severe form of arthritis affecting the spine.

The Oxford-based company officially launched at the end of last year on the strength of an exclusive worldwide license to develop namilumab for AS from Takeda—which has an equity stake in Izana—and a $1.7 million grant from the U.K. government’s Innovate U.K. fund.

It’s chaired by biopharma veteran and serial entrepreneur Professor Bryan Morton, C.B.E., who founded EUSA Pharma and Zeneus Pharma before selling them for $700 million and $360 million, respectively.

Namilumab was originally developed by German biotech Micromet, which was sold to Amgen for $1.2 billion. Originally called MT203, the antibody has been in development for more than a decade and was originally investigated for psoriasis but failed to make progress for that indication.

Takeda ran a phase 2 study in rheumatoid arthritis with positive results but doesn’t list the drug—which lies outside its trimmed-down focus of oncology, gastroenterology, neuroscience and vaccines—in its latest pipeline update.

AS is a new and potentially huge indication for the antibody, as the disease affects an estimated 4 million people in major markets around the world and represents a market worth in excess of $5 billion. Research published last year in the journal Nature suggests that GM-CSF production by T cells is an important pathogenic process in the disease.

The NAMASTE trial will recruit 40-plus adult patients with moderate to severe AS at 10 centers in the U.K., including Oxford University, and results are due next year, says Izana. It will compare a 150-mg subcutaneous dose of namilumab to a matched placebo, both administered four times over a 10-week study period. The main outcome measure will be the number of subjects with a 20% improvement on the Assessment in Ankylosing Spondylitis scale at 12 weeks.

AS "can be devastating, and for many patients with more advanced disease current treatments are often ineffective," says Oxford University musculoskeletal disease specialist Peter Taylor, Ph.D., F.R.C.P., who will lead the NAMASTE trial. "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."

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