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Takeda’s inflammatory bowel disease drug meets phase III targets

Positive late-stage clinical trial results for monoclonal antibody treatment vedolizumab

Takeda has reported positive phase III trial results for vedolizumab, its monoclonal antibody in development to treat inflammatory bowel disease (IBD).

The GEMINI I trial enrolled 895 patients with relatively hard-to-treat ulcerative colitis, in other words those who had already failed at least one conventional therapy, including biologic treatment with tumour necrosis factor (TNF) antagonists.

The subjects were randomised to receive either monthly or bimonthly doses of vedolizumab or placebo via intravenous infusion over one year, after a six-week induction phase in which they received three loading doses. The primary outcome measures were the proportion of patients with a clinical response and the proportion in clinical remission.

The top-line data has not yet been disclosed and will be presented at a forthcoming medical congress, but in a statement Takeda said that the trial met its endpoints with vedolizumab "providing statistically significant improvements in clinical response in the induction phase and clinical remission in the maintenance phase".

Adverse events which occurred in more than 10 per cent of patients across both the vedolizumab and placebo arms included colitis, headache and nasopharyngitis, said Takeda.

Takeda's chief medical officer Tadataka Yamada said: "We are very pleased with the outcomes of this pivotal trial, and the potential that vedolizumab holds for patients with this debilitating disease."

Vedolizumab is a novel alpha4 beta7 integrin antagonist and originally developed by Millennium Pharmaceuticals, which Takeda acquired for $8.8bn in 2008. The drug works by blocking a key inflammatory marker on white blood cells, preventing the migration of the cells into the intestinal wall. The antibody is also in phase III testing for Crohn's disease, another form of IBD.

Analysts at Decision Resources predicted towards the end of last year that sales of ulcerative colitis drugs across seven key markets (the US, France, Germany, Italy, Spain, the UK and Japan) will increase from $1.7bn in 2010 to $3bn by 2020.

Growth will be driven by advancing sales of TNF antagonists - particularly Abbott/Eisai's Humira (adalimumab) and Janssen Biotech/Merck/Mitsubishi Tanabe's Simponi (golimumab) - as well as vedolizumab and Pfizer's tofacitinib, another novel therapy for the condition which acts as a JAK inhibitor.

21st February 2012

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