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Two Phase 3 Studies of Vedolizumab Initiated in Patients with Inflammatory Bowel Disease

OSAKA, Japan, Jan. 22 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") announced today that its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc., has initiated two Phase III clinical trials for vedolizumab (MLN0002), an investigational compound for inflammatory bowel disease (IBD). The trials, known as the GEMINI(TM) program, will study vedolizumab for the treatment of ulcerative colitis and Crohn's disease, the two main types of IBD. Developed by Millennium, vedolizumab is a novel alpha4 beta7 integrin antagonist, a highly selective humanized monoclonal antibody.

"Dosing of the first patient in the Phase III development program of vedolizumab is an exciting milestone," said Brian Feagan, M.D., professor of Medicine at the University of Western Ontario, London, Canada and principal investigator of the GEMINI(TM) studies. "This treatment has great potential to improve the lives of patients with Crohn's disease and ulcerative colitis."

Though current IBD treatments have been effective for many patients with mild to moderate disease, a significant unmet need exists for those patients with moderate to severe IBD. Failure of current medical therapy for ulcerative colitis and Crohn's disease frequently leads to surgical removal of the colon in the case of ulcerative colitis, and multiple bowel resections in the case of Crohn's disease.

If approved by the U.S. Food and Drug Administration (FDA), commercialization of vedolizumab will be the responsibility of Takeda Pharmaceuticals North America, Inc., a subsidiary of Takeda Pharmaceutical Company Limited. Takeda has been a leader in gastroenterological therapies, such as Prevacid(R), for more than 10 years and is committed to bringing new therapies to market that may benefit patients.

"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," said Nancy Simonian, M.D., chief medical officer, Millennium. "Unlike existing IBD therapies, the unique gut-selective targeting of vedolizumab has the potential to benefit IBD patients without compromising systemic immune function."

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. Studies have demonstrated that vedolizumab works by blocking a key inflammatory marker on white blood cells, thereby preventing the migration of these inflammatory cells into the intestinal wall.

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. The GEMINI(TM) program was built upon the basis of favorable results of two randomized Phase II trials, one of which was published in the New England Journal of Medicine in 2005.

About Ulcerative Colitis and Crohn's Disease
Ulcerative colitis and Crohn's disease are chronic, relapsing-remitting conditions, caused by an overactive inflammatory response in the gastrointestinal tract. Common symptoms include diarrhea, rectal bleeding, incontinence, abdominal pain, fever, malaise and weight loss.

Source: Takeda Pharmaceutical Company

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