Phase 3 study of GSK'786 for the treatment of Crohn's disease
GlaxoSmithKline and ChemoCentryx announced that the first patient with Crohn's disease has initiated treatment in its Phase 3 induction study comparing GSK'786 (‘786 or GSK1605786) to placebo. The study is a randomized, double-blind, placebo-controlled trial that will involve approximately 600 patients to evaluate 500mg of '786 once daily or twice daily compared to placebo in patients with moderately-to-severely active Crohn's disease. The primary and key secondary endpoints are the proportion of subjects achieving a treatment-induced clinical response based on the Crohn's Disease Activity Index (CDAI) and the proportion of subjects achieving clinical remission.
'786 (formerly known as Traficet-EN) is a non-biologic, orally bioavailable CCR9 antagonist. CCR9 is a chemokine receptor that plays a central role in the inappropriate inflammatory response thought to underlie Crohn's disease. By blocking CCR9, '786 selectively impairs the movement of activated T cells that are involved in causing inflammation of the digestive tract. Its mode of action is believed to reduce inflammation while preserving normal immune function.
For more information call (650) 210-2900 or visit www.chemocentryx.com.