OSAKA, Japan, Jan. 8, 2014
Takeda Pharmaceutical Company Limited ("Takeda") announced today that vedolizumab (development code: MLN0002), an investigational drug for the treatment of moderate and severe ulcerative colitis (UC) and Crohn's disease (CD), has entered into two new phase 3 clinical trials in Japan.
The clinical trials are both placebo-controlled, multicenter, randomized, double-blind, parallel-group studies designed to evaluate the efficacy, safety and pharmacokinetics of vedolizumab as an induction and maintenance therapy for ulcerative colitis and Crohn's disease. Primary endpoints include clinical response at the 10th week (induction phase), and clinical remission after 60 weeks (maintenance phase).
"Many patients suffering from ulcerative colitis and Crohn's disease are eagerly awaiting new treatment options," said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. "We are striving to accelerate the development of this drug to deliver this effective and highly anticipated treatment option for patients in Japan as soon as possible."
Takeda has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in March 2013, as well as a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in June 2013, seeking approval for vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis or Crohn's disease.
About ulcerative colitis and Crohn's disease
Ulcerative colitis (UC) and Crohn's disease (CD) are the two most common forms of inflammatory bowel disease (IBD), which is marked by inflammation in the GI tract. UC usually only affects the large intestine, which includes the colon and the rectum. The most common symptoms of UC include abdominal discomfort and blood or pus in diarrhea. CD can impact any part of the digestive tract and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. There is no known cause for UC or CD, although many researchers believe that the interaction between genes, the body's immune system, and environmental factors may play a role. The aim of UC and CD treatments is to induce and maintain remission, or achieve extended periods of time when patients do not experience symptoms.
Vedolizumab, under development for the treatment of UC and CD, is a humanized monoclonal antibody that specifically antagonizes the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in UC and CD. By inhibiting alpha4beta7, vedolizumab limits the ability of these lymphocytes to infiltrate gut tissues.