Shares of Coronado Biosciences, Inc. (CNDO) fell 66.9% to $1.90 as a phase II study (n=250) on its pipeline candidate TSO (trichuris suis ova/CNDO-201) failed to meet both primary and secondary endpoints. Coronado Biosciences announced top-line data from a phase II study (TRUST-I), which is evaluating TSO for the treatment of Crohn’s disease.
Coronado Biosciences failed to achieve the primary endpoint of improved response defined by a 100-point reduction in the Crohn's Disease Activity Index (CDAI) and also the secondary endpoint of remission, indicating CDAI of 150 points. As patients treated with placebo did better than expected, patients treated with TSO did not reach target levels of improvement.
The 12-week, randomized, double-blind, placebo-controlled phase II study evaluated the safety and efficacy of TSO for the treatment of Crohn’s disease. The enrolled patients received either TSO 7500 or placebo once every two weeks. After the completion of this study, the patients were given an option of enrolling in a 12-week open-label extension trial, where they will receive TSO 7500 once every 2 weeks.
TSO is being evaluated for the treatment of autoimmune indications like Crohn’s disease, multiple sclerosis, ulcerative colitis, psoriasis, type I diabetes and rheumatoid arthritis.
Coronado Biosciences expects interim data on TSO in the fourth quarter of 2013 from another phase II study, TRUST-II, which is being conducted by Coronado’s development partner, Dr. Falk Pharma, for the treatment of Crohn’s disease. This study is evaluating the efficacy and safety of three different dosages of TSO in patients with active Crohn's disease.
Coronado Biosciences carries a Zacks Rank #3 (Hold). Currently, companies like Roche (RHHBY), Isis Pharmaceuticals, Inc. (ISIS) and Actelion Ltd. (ALIOF) look more attractive with a Zacks Rank #1 (Strong Buy).
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