Curemark is reporting that its phase III trail of its dietary enzyme for treating autism showed statistically significant improvements in both the core and non-core symptoms of autism. Of course this information is just from a press release and we shouldn't draw any conclusions before the results are published, but it does look promising.
For those of you who aren't familiar with this enzyme, its purpose is to help break down dietary proteins that people with autism might not be able to digest properly on their own. If this study has in fact managed to demonstrate improvements to the core symptoms of autism by altering the digestive process, that would be huge. The question would then no longer be whether there is a connection between GI symptoms and autism but rather what the connection is.
I look forward to the full results being published.
The press release from Curemark is below.
Curemark LLC Reports Positive Phase III Results of CM-AT In Children With Autism
Wednesday, December 7th - 2011
RYE, New York, Dec. 7, 2011 – Curemark LLC, a Rye, New York-based drug research and development company, today announced that its Phase III double blind randomized placebo controlled multicenter clinical trial of CM-AT for autism met its primary and secondary endpoints. The trial compared CM-AT to placebo in children with autism aged 3 – 8. Top line results demonstrate a statistically significant effect of CM-AT over placebo on both core and non-core symptoms of autism. Analysis of the full trial data is ongoing and the results will be presented at an upcoming medical meeting.
“We are extremely pleased with the results of our trial,” said Dr. Joan Fallon, CEO of Curemark. “We wish to thank all the children and their parents who participated in the study, and look forward to a full review of the data by the FDA.”
CM-AT has been granted Fast Track status by the Food and Drug Administration (FDA). The fast track programs of the Food and Drug Administration are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
(Read the rest, including relevant disclaimers, on the Curemark site).
Thanks MJ. A very interesting post indeed. A copy of the entry on the NIH Clinical Trials database can be found here: http://clinicaltrials.gov/ct2/show/NCT00881452
ReplyDeleteThis will hopefully be the place where all results are posted once published/patented.