Seaside reports positive data from STX209 Phase 2 study in ASD

Sep 9 2010

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”

"We observed marked improvement in the majority of patients treated in the STX209 autism spectrum disorders study, including reductions in agitation and tantrums," said Craig A. Erickson, M.D., Assistant Professor of Psychiatry, Chief of the Christian Sarkine Autism Treatment Center, Chief of the Fragile X Research Treatment Center at the Indiana University School of Medicine and an investigator in the study. "STX209 was well tolerated and most study participants continue to receive treatment in an open-label extension study. The importance of novel therapeutic development in neurodevelopmental disorders such as autism spectrum disorders and fragile X syndrome cannot be underestimated. This work will potentially open up a door to treating disorders that has, until recently, been firmly shut."

"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," said Randall L. Carpenter, M.D., President and Chief Executive Officer of Seaside Therapeutics. "In addition, we have now observed significant improvement in social interaction across two studies. We believe the reduction in social withdrawal is important as it suggests that STX209 is demonstrating efficacy for a core symptom of both fragile X syndrome and autism. We look forward to initiating later stage clinical studies of STX209 in both fragile X syndrome and autism spectrum disorders."