ELITE Disrupter Dr. Joan Fallon of CUREMARK

Dr. Joan Fallon





Discovering a Treatment for Autism

Dr. Joan Fallon likes to say she “went kicking and screaming into forming a biotech company.” She enjoyed treating children and wasn’t looking for a change. But when you make a potentially significant discovery about autism that could lead to a medical treatment, do you really have a choice?

Step one on Joan’s journey from clinician to biotech CEO took place 15 years ago when she noticed that children with autism ate bagels, waffles, and cereal, to the exclusion of protein. That piqued her curiosity, so she looked for an underlying cause of this dietary self-selection. What she found was that a large subset of children with autism have low levels of a major digestive enzyme that prevents them from fully digesting the protein they eat.

Step two for Joan was determining whether important behavioral changes were possible as a result of replacing the digestive enzyme. As a result, Joan needed to create a company, hire a team and finance a clinical program that could require tens of millions of dollars.

With a lack of venture capital in the autism space, Joan would have to raise the needed capital privately. To date, Curemark has raised more than $60M.

Curemark’s autism drug, CM-AT, has been given Fast Track designation from the FDA. Curemark was also granted a rolling review of its New Drug Application (NDA) for CM-AT and has commenced submitting its NDA. Curemark is in a second Phase III trial for an expanded population of children (that includes children with autism that have low levels and normal levels of the enzyme). Upon the successful completion of this trial, Curemark will be able to complete its NDA submission to the FDA. But Joan isn’t stopping at autism. Curemark is also working on potential treatments for ADHD, Parkinson’s disease, schizophrenia, and addiction.


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