UPDATE: Coronado Says Top-Line Results from Trust-I Phase 2 Trial of TSO for Crohn's Did Not Meet Primary Endpoint

Coronado Biosciences, Inc.

, a biopharmaceutical company focused on the development of novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer, today announced top-line results from TRUST-I, its Phase 2 clinical trial evaluating TSO (Trichuris suis ova or CNDO-201) in 250 patients with moderate-to-severe Crohn's disease. The TRUST-I study did not meet its primary endpoint of improving response, defined as a 100-point decrease in the Crohn's Disease Activity Index (CDAI), nor the key secondary endpoint of remission, defined as achieving CDAI < 150 points. In the overall patient population, response rate of patients on TSO did not separate from that of placebo. The randomization was stratified by disease activity as measured by CDAI. In the corresponding pre-defined subset analysis, TSO showed a non-significant improved response in patients with CDAI > 290. The lack of overall response was driven by higher-than-expected placebo response rate in patients with CDAI < 290. "While we are disappointed with the topline results, we are encouraged to see TSO's effect in patients with CDAI > 290. These results support the potential of TSO to regulate the immune system in patients with Crohn's disease, particularly those with higher level of disease severity," said Dr. Harlan F. Weisman, Coronado's Chairman and CEO. "We look forward to further analyzing the data from TRUST-I, along with the anticipated data from Dr. Falk Pharma's TRUST-II study in Crohn's disease, to identify the most appropriate development path for TSO." TSO was safe and well-tolerated, and adverse events were balanced between the TSO and the placebo group. The most common adverse event reported was abdominal pain and occurred in 11% of both TSO and placebo groups. Detailed trial results will be reported at upcoming medical and scientific meetings.  TRUST-I is a randomized, double-blind, placebo-controlled, U.S. multicenter study designed to evaluate the safety and efficacy of TSO in Crohn's disease. The trial enrolled and randomized 250 patients with moderate-to-severe Crohn's disease to receive either 7500 ova (n=125) or placebo (n=125) once every 2 weeks, for 12 weeks. The primary endpoint for the study is induction of response at 12 weeks, with induction of remission being a key secondary endpoint. Patients who completed the TRUST-I study had the option of enrolling in a 12-week open-label extension trial. All patients in the extension trial receive 7500 ova once every 2 weeks.  Coronado's development partner for TSO in Crohn's disease, Dr. Falk Pharma GmbH, is conducting TRUST-II, a phase 2, double-blind, randomized, placebo-controlled, multi-center study in Europe to evaluate the efficacy and safety of three different dosages of TSO in active Crohn's disease. The results from a second interim analysis are expected in the fourth quarter of 2013.