Takeda’s subsidary initiates two Phase III inflammatory bowel disease studies

The trials, known as the Gemini program, will study vedolizumab for the treatment of ulcerative colitis and Crohn’s disease, the two main types of inflammatory bowel disease (IBD). Developed by Millennium, vedolizumab is a novel alpha4 beta7 integrin antagonist, a highly selective humanized monoclonal antibody.

If approved by the FDA, commercialization of vedolizumab will be the responsibility of Takeda Pharmaceuticals North America, a subsidiary of Takeda Pharmaceutical Company.

The two randomized, placebo-controlled, blinded Phase III studies will enroll nearly 2,000 patients in more than 40 countries. Each trial consists of a six-week induction Phase followed by 46 weeks of maintenance therapy. In addition, patients will be given the opportunity to continue treatment for up to 100 weeks as part of a follow-up study for safety and efficacy. Vedolizumab will be administered as an intravenous infusion.

Vedolizumab is being studied to induce and maintain clinical response and remission in moderately to severely active IBD patients who have failed at least one conventional therapy. In ulcerative colitis, vedolizumab is also being studied for its effect on inducing and maintaining mucosal healing.

Nancy Simonian, chief medical officer of Millennium, said: We are excited to advance vedolizumab to pivotal Phase III clinical studies with the goal of registration in both ulcerative colitis and Crohn’s disease. Unlike existing IBD therapies, the unique gut-selective targeting of vedolizumab has the potential to benefit IBD patients without compromising systemic immune function.