Coronado Biosciences, Inc.’s candidate, TSO, is currently under development for the treatment of autoimmune diseases, such as, ulcerative colitis, multiple sclerosis, autism, psoriasis, type I diabetes and rheumatoid arthritis.
Coronado presented interim data from a pilot study of oral TSO (Trichuris suis ova or CNDO-201) for the treatment of autism.
The data was presented at the American College of Neuropsychopharmacology annual meeting.
The study enrolled 10 patients with autism spectrum disorder. In this double-blind, randomized, placebo-controlled, cross-over study, patients were under a 12-week treatment regimen either with TSO or placebo. This was followed by a 4-week washout phase and then 12 weeks of placebo or TSO treatment.
The TSO treatment was well tolerated. Interim data from the study revealed that TSO was statistically significant in three measures: the Montefiore-Einstein Rigidity Scale (MERS), the Repetitive Behavior Scale-Revised (RBS-R) Sameness Scale, and the Social Responsiveness Scale (SRS)-Repetitive Behaviors Scale. The final results are expected in the middle of 2014.
The company suffered a setback in Oct 2013 when TSO failed to meet both primary and secondary endpoints in its phase II study (TRUST-I), which is evaluating TSO for the treatment of Crohn’s disease. In Nov 2013, Coronado Biosciences announced the Independent Data Monitoring Committee Recommendation to discontinue the Falk phase II trial of TSO in Crohn’s disease.
Earlier this month, Coronado submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the commencement of a phase II study of TSO to treat moderate-to-severe chronic plaque psoriasis
The company currently does not have any marketed product. Hence, the progress on TSO candidate is encouraging. The share price rose 20.8% on the news.
Coronado currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks include Aeterna Zentaris Inc. (AEZS - Snapshot Report), Actelion Ltd. (ALIOF - Snapshot Report) and Jazz Pharmaceuticals plc (JAZZ - Analyst Report), each carrying a Zacks Rank #1 (Strong Buy).