The causes of autism and how prevalent it really is have been the stuff of impassioned debate and controversy. It has stirred a variety of opinions from its definition to diagnosis tools to the best treatment approach. A biotechnology company has developed a treatment for the disorder by focusing on the physiology. CureMark takes the view that digestive enzyme problems are a major component of autism. It argues that body’s inability to digest certain proteins affects amino acid production, which can interfere with brain function.
New York-based CureMark has raised $18.5 million as it prepares to submit a new drug application for its enzyme replacement therapy to the U.S. Food and Drug Administration, the company said in the statement. Earlier this year it completed a Phase 3 multicenter clinical trial of CM-AT for autism. The drug met primary and secondary endpoints in the double-blind, randomized, placebo-controlled study of children with autism aged 3 to 8.
A European institutional investor led the financing round according to the statement. Other investors identified on AngelList are Kimball Duncan and Allan Johnston.
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CM-AT was designated as a Fast Track drug in 2010 by the FDA. Drugs that qualify for that classification are for the treatment of serious conditions that fill an unmet medical need. It expedites the review process.
CureMark claims its drug is one of the first to go after the underlying physiology of autism. Earlier this year, a drug Seaside claimed was the first drug to treat the social impairments associated with autism failed in clinical trials.
There has been a great deal of interest in developing ways to diagnose autism faster with the idea that it can be treated more effectively at an early age. Among the companies developing diagnostics are SynapDx,
There are 380 clinical trials in various stages of development for autistic disorder, according to ClinicalTrials.gov’s website.
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Dr. Joan Fallon is the CEO of CureMark. In June she was part of a group of women entrepreneurs who spoke at the White House and urged government investment in early stage life science companies. She proposed a Federal Life Sciences Startup Package to help these companies manage costs for research and development and intellectual property protection.
