Coronado Biosciences, Inc., a biopharmaceutical company focused on the development of novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer, has initiated a National Institutes of Health (NIH)-sponsored phase 2 study evaluating TSO (Trichuris suis ova or CNDO-201) for the treatment of ulcerative colitis (UC). This multi-center study will be conducted by the Autoimmunity Centers of Excellence (ACE), which are funded through a multi-million dollar grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.

"The ACE grant funded by NIAID, in collaboration with Coronado Biosciences, will allow us to investigate not only the clinical impacts of TSO in ulcerative colitis but to also explore numerous mechanistic aspects and interfaces between mucosal immunology, the gut microbiome and genetics of this chronic immune-inflammatory disease," stated Dr Steven Hanauer, Principal Investigator of the study and Professor of Medicine and Clinical Pharmacology, Chief of Gastroenterology, Hepatology and Nutrition, and Director of The Logan Center for GI Clinical Research at the University of Chicago.

This phase 2 trial is a 12-week, randomized (1:1), double-blind, placebo-controlled clinical study 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 trial will randomize 120 patients to receive either TSO 7500 or placebo every two weeks for a total of six doses. The trial will evaluate the effect of TSO on clinical response of UC, intestinal mucosal immunological response, and inflammatory markers. 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.

"We are excited to have initiated the first phase 2 clinical trial studying TSO in ulcerative colitis and the third phase 2 clinical trial in our TSO program," said Dr. Harlan F. Weisman, Coronado's chairman and CEO. "This is another significant milestone for our clinical development program. 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 US and a second interim analysis from our development partner Dr Falk Pharma's TRUST-II trial in Europe."


TSO (Trichuris suis ova or CNDO-201), the microscopic eggs of the porcine whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and pro-inflammatory cytokines. The use of TSO as a therapeutic is based on the "hygiene hypothesis" and numerous animal and human studies. TSO was chosen as the biological agent of choice because it is not a human pathogen, and is spontaneously eliminated from the body within several weeks after dosing.

In February 2012, the company reported positive results from a phase 1 clinical study of TSO in patients with Crohn's disease, where TSO was shown to be safe and well tolerated. The phase 1 trial was a multi- center, sequential dose, dose-escalation, double-blind, placebo-controlled study of 36 patients with Crohn's disease. In August 2012, Coronado initiated TRUST-I (TRichUris Suis ova Trial), a phase 2 clinical trial of TSO in patients with Crohn's disease in the United States, which is expected to be completed in the fourth quarter of 2013.

Multiple investigator-sponsored clinical trials of TSO for the treatment of Crohn's disease, ulcerative colitis and multiple sclerosis have been completed, in which TSO demonstrated benefit with regard to accepted outcome measurements of remission of disease, and was shown to be well tolerated. In an open-label clinical trial with 29 patients reported in GUT in April 2004, TSO was shown to induce clinical remission in over 72 percent of patients with Crohn's disease after 24 weeks of treatment using the Crohn's Disease Activity Index as the primary outcome variable. As reported in the American Journal of Gastroenterology in April 2005, in a double-blind, randomized placebo-controlled trial in 54 patients with ulcerative colitis, TSO was shown to produce statistically significantly more responders than those treated with placebo (43.3% vs. 16.7%, p=.04).