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.

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