Previously, Curemark announced the successful results of its FDA Phase III double blinded clinical trial for CM-AT in children ages 3-8 with Autism who had low levels of the digestive enzyme chymotrypsin.
This new trial will help determine whether all children with Autism could potentially benefit from CM-AT.
Dr. Joan Fallon, Curemark Founder and CEO stated, "From the beginning, our goal has been to bring our proprietary Autism drug to as many children with the condition as possible. This trial has the potential to dramatically deepen our understanding around which children with Autism can benefit from CM-AT."
Curemark is currently submitting its rolling New Drug Application for CM-AT under the FDA’s Fast Track designation.
A Fast Track designation is designed to help facilitate the development and expedites the review of new drugs that are intended to treat serious or life-threatening conditions that demonstrate the potential to meet unmet medical needs.
The company is initiating this trial at 20 centers of excellence for Autism throughout the United States. "We have chosen some of the pre-eminent clinical sites and clinicians to conduct this clinical trial," states Dr. Matthew Heil, Curemark’s Chief Scientific Officer.