GSK moves Crohn’s disease drug into phase III
GlaxoSmithKline and its partner ChemoCentryx have started late-stage trials of GSK’786 for Crohn’s disease.
The initial 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.
GSK signed a $1.5 billion drug discovery alliance with ChemoCentryx in 2006 and ‘786 represents the most developed project from the partnership.
Bipharma firm ChemoCentryx focuses on discovering, developing and commercialising orally-administered therapeutics that target the chemokine and chemoattractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer.
Previously named Traficet-EN, ‘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 two biggest selling Crohn’s disease drugs are Abbott’s Humira and Merck’s Remicade, which made $1.6 billion and $674 million respectively in the second quarter last year.
UCB recently launched its inflammatory drug Cimzia for both rheumatoid arthritis and Crohn’s disease and it made 138 million euro in the first nine months of 2010.
Crohn’s is a chronic inflammatory condition of the gastrointestinal tract affecting more than half a million people in Europe and North America.