Coronado Biosciences, Inc. (CNDO) 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.
In Jul 2013, Coronado Biosciences completed patient enrollment for a phase II study, TRUST-I, which is evaluating TSO for the treatment of Crohn’s disease. Coronado expects top-line results from this study in the fourth quarter of 2013.
The company also expects data on TSO in the second half of 2013 from another phase II study, TRUST-II, which is being conducted by Coronado’s development partner, Dr. Falk Pharma GmbH, for the treatment of Crohn’s disease.
Coronado Biosciences also has a license and supply agreement with Ovamed GmbH related to TSO. In Dec 2012, the company amended its existing license and supply agreements with Ovamed. Coronado now has the manufacturing rights to TSO from Ovamed for North America, South America and Japan.
Apart from TSO, Coronado Biosciences’ other lead candidate is CNDO-109 which is being evaluated for the treatment of acute myeloid leukemia.
Coronado Biosciences carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Gilead Sciences Inc. (GILD) with a Zacks Rank #1 (Strong Buy), and Actelion Ltd. (ALIOF) and Jazz Pharmaceuticals Public Limited Company (JAZZ) with a Zacks Rank #2 (Buy).