Autism drugs move ahead
Even as Connecticut begins forcing insurance companies to cover medical bills for autism treatments, a pharmaceutical giant and startup alike are moving ahead with plans to produce drugs to treat the disorder.
As part of the American Recovery and Reinvestment Act, the National Institutes of Health is awarding as much as $60 million nationally for research into autism and related disorders. NIH has yet to reveal funding recipients. The agency hopes to finance research on developing and testing diagnostic tools and to initiate clinical trials to test early interventions.
According to the Centers for Disease Control, about one in 150 children is afflicted with an autism spectrum disorder; that number has been increasing in recent years, with researchers hypothesizing causes ranging from a environmental or genetic causes; to a controversial vaccine administered to children; to earlier and better diagnostic capabilities.
Children with autism and other pervasive developmental disorders like Asperger syndrome have more difficulty making social connections, manifested in forms as mild as repetitious behavior and as severe as complete social withdrawal and inability to communicate.
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In 2006, a Harvard School of Public Health study found that the societal cost for treating a child with autism over his or her lifetime was $3.7 million, including doctor bills, special education and lost productivity costs upon reaching adulthood.
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To date in the United States, autistic children have been treated through a mix of behavioral psychology approaches. Only a few antidepressants and antipsychotics have been approved by the Food and Drug Administration to treat symptoms in some autistic children, including Risperidone and Celexa.
Drug companies large and small are fast tackling the subject however. At its massive research lab in Groton, Pfizer Inc. reportedly has a created an autism spectrum disorders unit with more than a dozen researchers, even as it absorbs Wyeth Pharmaceuticals, a deal driven in part by Wyeth”™s research into ailments like Alzheimer”™s disease.
And last month, Rye, N.Y.-based Curemark L.L.C. revealed it had received $6.5 million in venture capital funding as it develops drug candidates that could potentially treat autism.
Just the month before, Curemark founder and CEO Dr. Joan Fallon gave a keynote address at a genetics conference held at Harvard Medical School.
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Curemark”™s treatment is based on Fallon”™s research on an observed phenomenon that many children with autism do not appear to digest protein.
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Curemark”™s powder would be taken with meals to help those children increase their digestion of protein, in theory giving their nervous systems easier access to the building blocks for manufacturing neurotransmitters and other natural systems that could help alleviate their symptoms.
In March, the Food and Drug Administration approved Curemark to proceed with a phase III clinical trial to assess the drug”™s impact on children with autism. Curemark has yet to provide an update on enrollment details and progress of the clinical trial.
“To the best of my knowledge, there are no other companies in phase III,” Fallon said. “Our trials have recently commenced are expected to last at least a year.”
Curemark was one of several life-science startups in Connecticut and New York to attract significant funding recently. Branford-based Marinus Pharmaceuticals Inc. received more than $20 million in the second quarter as it develops drugs for epilepsy and other disorders of the central nervous system, with investors including Westport-based Canaan Partners and Foundation Medical Partners of Norwalk. Stamford-based Purdue Pharma is also listed among Marinus”™ partners.