FDA Grants Fast Track Status To Curemark CM-AT Autism Treatment

CM-AT is based on Dr Fallon’s research that showed enzyme deficiencies in autistic children, resulting in an inability to digest protein. The inability to digest protein affects the production of amino acids, the building blocks of chemicals essential for brain function.

Curemark said that CM-AT will be one of the first therapies to address the underlying physiology of autism, rather than just treat its symptoms.

Curemark is conducting Phase III clinical trials for CM-AT at 12 sites across the country with a total 170 children. Ten of the sites are now enrolling patients.

Joan Fallon, founder and CEO Curemark, said: “We are very excited about the FDA’s Fast Track designation for CM-AT. We’re making rapid progress with the CM-AT trials and being named as a Fast Track drug means that we potentially can get our autism treatment to market faster for the children and parents who will benefit from it.”