Coronado: Autism Data May Be Interesting Print E-mail
By Brian Wilson-Lead Contributor   
Monday, 16 December 2013 08:55
Coronado Biosciences (NASDAQ: CNDO) is a company that is still picking up the pieces after the company’s most promising therapy – TSO (Trichuris suis ova, or CNDO-201) failed to meet its primary endpoint in the Phase II TRUST-I trial. This endpoint was defined as an improved response in the treatment arm versus placebo arm as measured by the Crohn’s Disease Activity Index (CDAI).

The release of top-line results, which came in October 2013, marked a huge catalyst for CNDO shares indeed. Had the company succeeded, we believe the company could have been trading at $15 or higher based on the large patient population (n=250). But it’s not very useful to speculate on this specific development program anymore, since the remaining value is found in other indications and other drugs.

Crohn’s disease was the company’s most promising indication for TSO due to the sheer size of it and the lack of effective autoimmune therapies to treat the condition. However, there are still development programs in Ulcerative Colitis, Multiple Sclerosis, Autism, and Psoriasis. The program for autism produced some interesting data that sent CNDO stock up over 20% last Friday.

Autism Data

Interim data collected by Dr. Eric Hollander from a pilot study of orally administered CNDO-201 as a treatment for autism was presented at the American College of Neuropsychopharmacology Annual Meeting in Hollywood, Florida.

The study is a double-blind, randomized, placebo-controlled study with crossover. High-functioning adult autistics were enrolled (n=10) if they demonstrated a history of allegies and/or a family history of immune-inflammatory illness. Treatment lasted for 12 weeks with either CNDO-201 (@ 2,500 ova total) or the placebo, and this was followed by a 4-week washout phase. Another 12 weeks of therapy was given.

Five patients completed the study, and demonstrated a statistically significant separation from placebo patients in the Montefiore-Einstein Rigidity Scale (MERS), the Repetitive Behavior Scale-Revised (RBS-R) Sameness Scale, and the Social Responsiveness Scale (SRS) – Repetitive Behaviors Scale. No serious adverse events or tolerability issues were witnessed, and we expect final results in the middle of 2014.

This is very interesting stuff that could revive CNDO-201 and draw some attention to the other indications that the drug was being developed for prior to the Crohn’s Disease setback.


CNDO-201 is a very strange therapeutic that is based on the “hygiene hypothesis”, which states that our immune systems have become “overactive” as a result of modern lifestyle – hence a rise in autoimmune disease. CNDO-201 is actually a therapy made of (safe) microscopic parasites that redirect the immune system’s attention.


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