Seaside Therapeutics commences STX209 Phase 2b study in autism spectrum disorders

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social impairment—a core symptom of autism spectrum disorders—including symptoms such as preference to be alone, being withdrawn or isolated, and lack of social reactivity.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