Coronado Biosciences TSO in Phase II study., Coronado Biosciences, Inc. (CNDO – Snapshot Report) recently announced the initiation of a phase II study on TSO (trichuris suis ova or CNDO-201) for the treatment of ulcerative colitis (UC). The study will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), which is a part of the National Institutes of Healt (NIH). The sponsorship will come in the form of a multi-million dollar grant from the NIAID.
The 12-week, randomized (1:1), double-blind, placebo-controlled phase II study will evaluate the safety and efficacy of TSO for the treatment of active left-sided UC. The study will also study the effects of TSO on mucosal immune state and microbiota. The study will enroll 120 patients who will be given a total of six doses of either TSO 7500 or placebo every two weeks.
TSO is being evaluated for the treatment of autoimmune indications like Crohn’s disease, multiple sclerosis, autism, psoriasis, type I diabetes and rheumatoid arthritis.
This study adds to two existing phase II studies which are evaluating TSO for the lead indication, Crohn’s disease under the company’s inflammatory bowel diseases program.