Monday, May 14, 2012

CROHN'S DISEASE - GEMINI Trial - Vedolizumab meets primary endpoint

In a Phase 3 trial (GEMINI) which enrolled 1,115 patients with   moderate to severe active Crohn’s disease who have failed at least one conventional therapy, including TNFα antagonists.Vedolizumab met the primary endpoint of clinical remission  Many of the patients included in the study had failed two or more TNFα antagonists. Patients received a year of vedolizumab (MLN0002) or placebo treatment, starting with six weeks of induction therapy.

Takeda is developing Vedolizumab and is currently in Phase  3.  It is a humanized monoclonal antibody against α4β7 integrin, which 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 ulcerative colitis and Crohn’s disease.