Coronado Begins Phase 2 Study Of CNDO-201 For Treatment Of Ulcerative Colitis

(RTTNews) - Biopharmaceutical company Coronado Biosciences, Inc. (CNDO) Thursday said it initiated the phase 2 study evaluating TSO (Trichuris suis ova or CNDO-201), for the treatment of ulcerative colitis or UC. This multi-center study, which is sponsored through a multi-million dollar grant from the National Institute of Allergy and Infectious Diseases, part of National Institutes of Health, will be conducted by the Autoimmunity Centers of Excellence.

The trial is designed to examine the safety and efficacy of TSO treatment in active left-sided UC and its effects on mucosal immune state and microbiota. The primary endpoint is clinical response, defined as a reduction in the Mayo score of = 3 and = 30% from baseline, along with either a decrease from baseline in the rectal bleeding sub-score of >1 point or an absolute rectal bleeding sub-score of 0 or 1 at Week 12.

"This study further advances our inflammatory bowel diseases (IBD) program and compliments our lead indication, Crohn's disease. We completed enrollment of 250 patients in our phase 2 TRUST-I trial, which we announced on July 1, 2013, and expect to report data from two large phase 2 trials evaluating TSO in Crohn's disease during the fourth quarter of 2013: Top-line results from Coronado's TRUST-I trial in the U.S. and a second interim analysis from our development partner Dr. Falk Pharma's TRUST-II trial in Europe." said Harlan Weisman, Coronado's Chairman and CEO.