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core symptom of autism spectrum        disorders—including symptoms such as preference to be alone, being        withdrawn or isolated, and lack of social reactivity.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