Phase IIb study with STX 209 (Seaside Therapeutics) reports on efficacy in Autism Spectrum Disorder

Study 209AS208 is a randomized, double-blind, placebo-controlled Phase IIb study which , evaluated the safety, tolerability, and efficacy of STX 209 ( arbaclofen) from Seaside Therapeutics, in 150 subjects (age 5 to 21 years) with Autism Spectrum Disorder (ASD), with a particular focus on the core impairments of social function.

Patients were randomized to receive either arbaclofen or placebo and treated for 12 weeks. While the study did not show improvement on the primary endpoint of social withdrawal, it did demonstrate significant improvement on the Clinical Global impression of Severity scale. Secondary analyses of the data revealed significant improvement on the Vineland-II Socialization scale, a gold-standard psycho-educational measure of social function, in higher functioning patients.

.Seaside intends to confirm its results by initiating another controlled trial of arbaclofen in patients with ASD.