Takeda Pharmaceutical Co is celebrating after presenting promising late-stage data on its investigational bowel drug vedolizumab.
The Japanese drugmaker has announced top-line positive results from its GEMINI I Phase III trial evaluating vedolizumab in 895 patients with moderately to severely active ulcerative colitis who have failed at least one conventional therapy, including tumour necrosis factor (TNF)-alpha antagonists, such as Abbott Laboratories' blockbuster Humira (adalimumab). Patients received a year of vedolizumab, also known as MLN0002 or placebo, starting with six weeks of induction therapy.
Takeda says both phases of the trial met their primary endpoints, providing statistically significant improvements in clinical response in the induction phase and clinical remission in the maintenance stage. Detailed results will be presented at an upcoming medical congress.
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". The drug is a novel alpha-4 beta-7 integrin antagonist, a highly selective humanised monoclonal antibody, which works by blocking a key inflammatory marker on white blood cells.
These cells have been shown to play a role in mediating the inflammatory process in UC and Crohn’s disease. Takeda got hold of vedolizumab, which is also in Phase III for Crohn's, through its $8.80 billion acquisition of the USA’s Millennium Pharmaceuticals in 2008 and analysts believe it has the potential to be a blockbuster.