ChemoCentryx, Inc., announced today that Phase II/III clinical data from the Company's PROTECT-1 (the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial) of Traficet-EN(TM) (CCX282-B) in patients with moderate-to-severe Crohn's disease demonstrated clinical efficacy with a favorable safety and tolerability profile. The study demonstrated evidence of clinical efficacy in the reduction of disease severity as defined as a 70-point decrease in the Crohn's Disease Activity Index (CDAI) in patients treated with Traficet-EN over the course of 12 weeks; the more stringent measure of at least a 100-point decrease in the CDAI score was also met by week 12. In addition, Traficet-EN treatment benefited patients who had previously not responded to anti-TNF treatment. These results reported from the Induction phase of the PROTECT-1 trial, were presented today in a poster titled "PROTECT-1 Study of Intestine-Specific Chemokine Receptor Antagonist CCX282-B (TRAFICET-EN) in Crohn's Disease" by Satish Keshav, M.D., Department of Gastroenterology, John Radcliffe Hospital, Oxford University at the GASTRO 2009 United European Gastroenterology Federation and World Gastroenterology Organization (UEGW/WCOG) conference in London.
Traficet-EN is an orally-active inhibitor of the chemokine receptor known as 'CCR9', which is selectively expressed by inflammatory T cells to migrate to the digestive tract in a process that ultimately results in the persistent inflammation underlying the disease. Targeting the CCR9 chemokine receptor represents a novel approach for the treatment of Crohn's disease and other inflammatory disorders of the gastrointestinal system.
Study Results
Results showed that the CDAIs disease treated with 500 mg once-daily dose (QD) of Traficet-EN for 12 weeks was 61% versus 47% for placebo>