The U.S. Centers for Disease Control and Prevention estimate that 1 in 68 children in the United States have been diagnosed with Autism.
There is currently no approved drug on the market that treats the core symptoms of Autism. At Curemark, we are working to change that. Curemark’s lead drug candidate, CM-AT, has received “Fast Track” designation from the U.S. Food and Drug Administration (FDA). FDA has also granted Curemark a rolling review of its New Drug Application for CM-AT.
Many children with Autism exhibit impaired protein digestion, which may or may not manifest in self-restricted diets. The inability to digest protein affects the availability of essential amino acids in the body. CM-AT, our lead drug candidate, is designed to enhance protein digestion thereby potentially restoring the pool of essential amino acids. Essential amino acids play a critical role in the expression of several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine.
The Blüm™ Study, our Phase III clinical trial for CM-AT in children aged 3 – 8 years old, is underway in over 25 sites across the United States. For more information about the trial, visit clinicaltrials.gov.
We are enrolling children between ages 3 and 8 for Blüm™, a US-wide study of our biologic CM-AT for Autism. If you are interested in participating, visit the site below to learn more about the closest site near you.
In the video above, Curemark founder and CEO, Dr. Joan Fallon gives a quick overview of the critical “brain/gut” connection in Autism, which our treatment aims to address.