Monday, October 14, 2013

Coranado Biosciences: TRUST I Trial Fail for Crohn's...Trust II Data Due in December

So today in a press release Coronado Biosciences which has been developing the treatment of TSO pigworms to treat Crohn's disease. The stock as a result plunged 65% as a result. The trial consisted of 250 patients (125 in the placebo and 125 that received treatment). The treatment group received 7500 ova every 2 weeks for 12 weeks. The most common side effect was abdominal pain which occurred in 11% of the placebo group and treatment group (which really isn't a side effect if the placebo group had the same rate as the treatment group and Crohn's is general has this side effect anyways). 

The clinical endpoint or what they use to see if CDAI dropped 100 points in Crohn's patients (CDAI is used to measure how severe Crohn's disease is). The other clinical endpoint was to see if CDAI dropped by more than 150 points. What the trial did show was an improved response who had a CDAI of 290.

In December 2013 it is expected that TRUST II data from Europe will become available. 212 patients are enrolled in this trial according to Clinical Trials website. This trial actually gives patients three different doses (low, medium, and high doses) instead of just giving patients the treatment or placebo. 

Past studies have shown that TSO is quite remarkable. This study from Gut showed that close to 80% of patients had a response. In this study 86% of Crohn's patients achieved remission. This study from 2004 published showed that 43% of patients with ulcerative colitis saw improvement. This study talks about a 33 year old financial analyst (who had Crohn's since he was a teenager) took the treatment and saw a significant reduction in his symptoms and inflammation markers. 

I wish the FDA would only test drugs for safety and let consumers, doctors, and researchers figure out if the drugs are worth taking. Everyone has a different biology and make up and TSO pigworms may work in some while not working in others. Why should the FDA tell people how to use drugs? (I am okay with them just approving drugs on a safety basis). By not allowing people to experiment and try the TSO pigworms many people will be harmed. Experimentation is needed for a disease that harms so many and ruins the lives of many more. I hope the TRUST II results have positive results. Also Corando Biosicences is also studying the drug for autism, psoriasis, and multiple sclerosis (which if any were a big success would be worth some serious money).  

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