Seaside Therapeutics, Inc. announced today positive data from an open-label Phase 2 study of STX209 conducted in patients with autism spectrum disorders (ASD). The primary endpoint of the study, an improvement on the Irritability subscale of the Aberrant Behavior Checklist (ABC-I), achieved statistical significance (p<0.001). In addition, STX209 demonstrated statistically significant improvements across a number of other global and specific neurobehavioral outcomes, including improvements on the Social Withdrawal subscale of the Aberrant Behavior Checklist (ABC-SW, p<0.001), which assesses a core symptom of ASD. A significant number of patients enrolled in the study are participating in an open-label extension study. STX209 is a selective gamma-amino butyric acid type B (GABA-B) receptor agonist being studied for the treatment of ASD and fragile X syndrome (FXS). In July 2010, Seaside reported clinically meaningful data from a randomized, placebo-controlled study of STX209 in individuals with FXS. The Company intends to present the full results from both studies at future medical meetings.
“These study results add to a growing body of evidence supporting the potential of STX209 to play an important role in treating neurodevelopment disorders such as fragile X syndrome and autism spectrum disorders”