ChemoCentryx, Inc., today announced that it reported one-year results from the Company's PROTECT-1 Study (the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial) of Traficet-EN™ (CCX282-B) in patients with moderate-to-severe Crohn's disease. Traficet-EN, an orally bioavailable CCR9-specific chemokine receptor antagonist showed clinical efficacy in a 12-week Induction period, as well as a 36-week Maintenance period. Specifically, Traficet-EN demonstrated evidence of clinical efficacy in the reduction of disease activity as defined by a 70-point or 100-point decrease in the Crohn's Disease Activity Index (CDAI) during the Induction period. Furthermore, approximately 50% of patients receiving Traficet-EN in the Maintenance period were in clinical remission (CDAI less than 150) by the end of the 36 weeks compared to 31% of patients receiving placebo. Traficet-EN continued to be safe and well tolerated. Phase III clinical trials designed to evaluate Traficet-EN in patients with moderate-to-severe Crohn's disease are expected to initiate before the end of the year.
Additionally, conclusive evidence was provided that the involvement of CCR9 and its chemokine ligand (TECK) in inflammatory bowel disease (IBD) is not just restricted to the small bowel, but is relevant to inflammation of the large bowel as well. These findings as well as the Traficet-EN one-year study results were highlighted at the 18th United European Gastroenterology Federation (UEGW) meeting in Barcelona, Spain in a poster presentation entitled "One-Year Results from PROTECT-1 Study of Intestine-Specific Chemokine Receptor Antagonist CCX282-B (Traficet-EN) in Crohn's Disease" and in an oral presentation entitled "CCR9 Inhibition in the Treatment of Colonic Inflammation" presented by Dr. Juan C. Jaen, Senior Vice President, Drug Discovery and Chief Scientific Officer, ChemoCentryx, Inc.
"The PROTECT-1 study data provide a powerful validation for targeting the chemokine system to treat inflammatory diseases," stated Thomas J. Schall, Ph.D., President and Chief Executive Officer, ChemoCentryx. "Maintaining remission in patients with a complicated disease such as Crohn's through this novel mode of action is nothing short of groundbreaking. Complementing the success of this trial is the fact that our scientists have for the first time definitively identified CCR9 and its chemokine ligand in the large bowel which will no doubt expand the number of digestive disorders that Traficet-EN could potentially treat. We are proud of these accomplishments which further validate the strength of our technology as we continue to advance novel chemokine-based medicines through the clinic to treat inflammatory and autoimmune diseases."
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