Data from phase III trials of Takeda’s inflammatory bowel disease (IBD) drug vedolizumab suggests the company’s optimism for the candidate may be well-founded.
The results – published in the New England Journal of Medicine (NEJM) – show that the drug is effective for induction and maintenance therapy in patients with both ulcerative colitis (UC) and Crohn’s disease (CD), the two principal forms of IBD.
Vedolizumab (formerly MLN0002) is a gut-selective humanised monoclonal antibody targeting alpha4beta7 integrin, a receptor on white blood cells thought to play a pivotal role in UC and CD.
The GEMINI I trial in UC showed that vedolizumab achieved a clinical response at week six in 47 per cent of vedolizumab-treated patients, compared to 26 per cent of the placebo arm. Remission rates at 52 weeks were 45 per cent in patients given vedolizumab every four weeks and 42 per cent when dosed every eight weeks, compared to 16 per cent of patients on placebo.
In the GEMINI II study in CD – which tends to be harder to treat than UC – vedolizumab achieved clinical responses at six weeks in 15 per cent of vedolizumab patients versus 7 per cent of controls, with remissions seen in 36 per cent of the four-week dose patients and 39 per cent of the eight-week group. Clinical remissions occurred in a little under 22 per cent of patients receiving placebo.
Takeda has suggested for some time that vedolizumab is one of the brightest stars in its pipeline as it weathers the loss of patent protection on big-selling diabetes treatment Actos (pioglitazone), but there has been little visibility on data ahead of the NEJM publication.
The drug was filed for approval in the US in June and in the EU in March, but remains in early-stage development in Japan, according to Takeda’s first-quarter results statement.
The drug is being billed as a potentially safer alternative to tumour necrosis factor (TNF) blockers such as Johnson & Johnson/Merck/Mitsubishi’s Remicade (infliximab) and AbbVie’s Humira (adalimumab), which have a systemic immune-suppressing effect which can lead to serious infections, including tuberculosis.
Takeda’s drug has shown efficacy in both TNF-naïve patients and those who have failed on TNF blockers, according to Takeda.
Overall, the Crohn’s sector is expected to increase from a value of around $3.8bn in the seven-largest pharma markets to $5.6bn in 2021, while the market for UC will increase from $1.7bn in 2010 to $3bn by 2020, according to Decision Resources.