Coronado Biosciences, Inc.
) 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
Isis Pharmaceuticals, Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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