CureMark preparing for the submission of treatment for autism: enzyme replacement therapy

researchCureMark, a New York based company has raised $18.5 million to aid its preparation for a new treatment that they believe will answer some of the problems regarding autism. Claiming to be the pioneer in researching and testing of the condition’s underlying physiology, CureMark posits that one of the major elements that comprise autism is a malfunctioning digestive process. It says that when the body fails to digest certain proteins, the production of amino acid is thereby affected. Consequently, the brain of that person also malfunctions.

CM-AT is one of the Fast Track drugs recognized by the U.S. Food and Drug Administration (FDA) back in 2010. Fast Track drugs are meant to cure serious medical conditions that still have gaps to fill. Since CureMark’s potential treatment is CM-AT, the U.S. FDA’s review process will move forward faster.

Through a series of tests, primary and secondary endpoints in the whole study were met. Children aged three to eight who were battling with autism were crucial to the study. CureMark has finished the Phase 3 of CM-AT trial.

Due to the promise CureMark’s recent advancement brings, Kimball Duncan, Allan Johnston and other investors have shown support for the project. Chief Executive Officer of CureMark, Dr. Joan Fallon, along with several other women entrepreneurs last June, had a dialogue with the White House. They were asking the government to lead the investments in life science companies that are just starting. Fallon suggested that the White House give what she calls a Federal Life Sciences Startup Package that will aid these emerging life science companies in research, development, and intellectual property protection costs.

Aside from CureMark, there are 380 clinical trials for autism. There are also companies that believe in early treatment of autism as the best time for treatment like SynapDx. However, there are also documented cases of failed clinical trials such as Seaside which just this year claimed to have pioneered the treatment for social deficiencies.