ARTICLE | Clinical News

Seaside reports STX209 data

July 27, 2010 12:49 AM UTC

Seaside Therapeutics Inc. (Cambridge, Mass.) said it plans to start "late-stage" clinical trials of STX209 this year after reporting Phase II data of STX209 to treat fragile X syndrome. The GABA B receptor agonist showed clinically meaningful, but not statistically significant improvements in global and specific neurobehavioral outcomes vs. placebo, including investigators' assessments of Clinical Global Impressions of Improvement (CGI-I) (p=0.18) and Severity (CGI-S) (p<0.1), and investigator and caregiver treatment preference (p<0.1 for both). The trial missed the primary endpoint of significantly improving irritability subscale scores on the Aberrant Behavior Checklist (ABC-I) from baseline to week 4 vs. placebo in the per protocol population (n=54). ...