Takeda Pharmaceutical Company has announced positive top-line results from a pivotal Phase III trial of vedolizumab in patients with moderately to severely active ulcerative colitis, who have failed at least one conventional therapy.
The randomised, placebo-controlled GEMINI I trial evaluating vedolizumab in 895 patients has met primary endpoints of improvements in clinical response in induction and clinical remission in maintenance.
In the double-blinded trial, patients were given vedolizumab (MLN0002) or placebo treatment for a year, starting with six weeks of induction therapy.
The most common adverse events (more than 10%) such as colitis, headache and nasopharyngitis were observed in both the vedolizumab arm and the placebo arm.
Takeda chief medical and scientific officer Tadataka Yamada said the company was pleased with the outcome of the trial and the potential that vedolizumab holds for patients with this debilitating disease.
"We are very pleased with the outcomes of this pivotal trial, and the potential that vedolizumab holds for patients with this debilitating disease," said Tadataka Yamada, M.D., chief medical and scientific officer, Takeda.
"We thank the patients and investigators for their engagement and participation in this clinical evaluation of vedolizumab."
Vedolizumab is an investigational humanised monoclonal antibody against a4ß7 integrin, which is expressed on a subset of circulating white blood cells.
The cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis and Crohn's disease.
Ulcerative colitis is a chronic, relapsing-remitting condition, caused by an overactive inflammatory response in the gastrointestinal tract.
Common symptoms of ulcerative colitis include diarrhoea, rectal bleeding, incontinence, abdominal pain, fever, malaise and weight loss.
Takeda is a research-based company focused on pharmaceuticals and is located in Osaka, Japan.