Curemark has reported 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.
CM-AT has been granted Fast Track status by the FDA. The fast track programs of the FDA 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.