GlaxoSmithKline (GSK) and ChemoCentryx, Inc. announced today that the first patient with Crohn's disease has initiated treatment in the initial pivotal induction study comparing Traficet-EN, now designated GSK1605786 ('786), to placebo. This marks the start of the Phase III clinical development programme for '786 for the treatment of this serious and chronic disease.
'786 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.
The Phase III clinical development programme, that is anticipated to include another pivotal induction study and a pivotal maintenance study, in addition to other studies, will evaluate the efficacy and safety of '786 for inducing a response and remission (reduction or disappearance of symptoms) and maintaining remission in over 2,500 patients with moderately-to-severely active Crohn's disease.
Earlier trial data of '786 for Crohn's disease have been presented at recent congresses including DDW and UEGW, 2010.
Study design
The initial pivotal induction study is a randomised, double-blind, placebo-controlled study 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.
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