Coronado Biosciences, Inc.
) 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
The 12-week, randomized (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
Coronado Biosciences carries a Zacks Rank #3 (Hold). Companies
that currently look well-positioned include
Gilead Sciences Inc.
) with a Zacks Rank #1 (Strong Buy), and
Jazz Pharmaceuticals Public Limited Company
) with a Zacks Rank #2 (Buy).
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