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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Seaside Therapeutics, Inc. announced today the initiation of a randomized, double-blind, placebo-controlled Phase 2b study to evaluate the effects of STX209 (arbaclofen) on social impairment in children, adolescents and adults (ages 5 to 21) with autism spectrum disorders (ASD). The Company announced positive results from an open-label Phase 2a study of STX209 in September of 2010.“There are currently no FDA-approved therapeutics to treat the core symptoms of autism spectrum disorders, creating a vast unmet need for the millions of individuals and their families affected by this condition in the US and EU alone,” said Randall L. Carpenter, M.D., President and Chief Executive Officer of Seaside Therapeutics. “In our open-label Phase 2a study of STX209, we observed significant improvements in social impairment—a core symptom of autism spectrum disorders—including symptoms such as preference to be alone, being withdrawn or isolated, and lack of social reactivity. We are spearheading late-stage development of a drug candidate that has the potential to change the treatment paradigm for autism spectrum disorders—addressing core symptoms—and are truly excited about the prospect of helping patients and their families achieve an improved quality of life.”
The Phase 2b study is expected to involve approximately 25 clinical sites in the United States and enroll 150 subjects. Patients will be randomized to receive STX209 or placebo. A flexible dose titration schedule will be utilized during the first 4 weeks of the treatment period to achieve the optimal titrated dose. The total duration of treatment is 12-weeks. The study is designed to measure the efficacy, safety and tolerability of STX209. The primary efficacy endpoint will evaluate social behavior. Subjects who complete the entire study may be eligible to enroll in a subsequent open-label study. Details of the study can be obtained at www.clinicaltrials.gov and at www.seasidetherapeutics.com or by calling 1-877-713-9009, option 8.
About STX209:
STX209 is an oral selective gamma-amino butyric acid type B (GABA-B) receptor agonist. Pathologies observed in certain neurodevelopmental disorders, including fragile X syndrome (FXS) and autism spectrum disorders (ASD), are believed to be caused by excessive activation of glutamate receptors and abnormally high ratios of excitatory to inhibitory neurotransmission in the brain. GABA-B receptors play an important role in modulating the release of glutamate and optimizing the ratio of excitatory to inhibitory neurotransmission. STX209 has demonstrated efficacy in preclinical models, suggesting that it may improve function in individuals with FXS and ASD.
With STX209, Seaside has successfully completed the largest, randomized, blinded, placebo-controlled trial (Phase 2) in patients with FXS and an open-label Phase 2a exploratory trial in patients with ASD. A Phase 3 study in adolescents and adults (ages 12 to 25) with FXS began in May of 2011 and a Phase 2b study in children, adolescents and adults (ages 5 to 21) with ASD began in June of 2011. An additional Phase 3 study in children (ages 5 to 11) with FXS is expected to begin in early summer 2011.
About Autism Spectrum Disorders:
Autism Spectrum Disorders (ASD) are characterized by three hallmark symptoms that can range from mild to disabling, including difficulties with social interaction, problems with verbal and nonverbal communication and repetitive behaviors or narrow, obsessive interests. Experts estimate that as many as 1 in 110 children are diagnosed with an autism spectrum disorder, with boys being four times more likely than girls to be diagnosed with the disorder. There is no cure for autism and there are currently no FDA-approved therapeutics to treat the core symptoms of ASD.
About Seaside Therapeutics:
Seaside Therapeutics, Inc. is creating novel drug treatments to correct or improve the course of fragile X syndrome, autism and other neurodevelopmental disorders. The Company is dedicated to translating breakthrough discoveries in neurobiology into therapeutics that improve the lives of patients and their families. For more information please visit www.seasidetherapeutics.com.
Contacts
MacDougall Biomedical Communications
Sarah Cavanaugh/Kari Watson
781-235-3060
scavanaugh@macbiocom.com
kwatson@macbiocom.com
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