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Seaside publishes research supporting disease-modifying potential of STX209 for fragile X syndrome
Date:9/19/2012

de of effect observed with STX209 is comparable to that reported for selective mGluR5 antagonists. These results demonstrate that STX209 has the potential to modify the underlying disease of patients with FXS and support the development of STX209 in the clinic.

Study authors included Christina Henderson, Aileen M. Healy, Matthew Shumway, Rebecca S. Hammond, Friso R. Postima, Christopher Brynczka, Roger Rush and Randall L. Carpenter of Seaside Therapeutics; Lasani Wijetunge and Peter C. Kind of the University of Edinburgh; Mika Nakamoto Kinoshita and Stephen T. Warren of Emory University; Alicia Thomas and Richard Paylor of Baylor College of Medicine; Peter W. Vanderklish of The Scripps Research Institute; and Mark F. Bear of the Massachusetts Institute of Technology.

The accompanying paper, "Effects of STX209 (arbaclofen) on neurobehavioral function in children and adults with fragile X syndrome: a randomized, controlled, Phase 2 trial," detailed the results previously announced from the Company's Phase 2 trial. The randomized, double-blind, placebo-controlled Phase 2 study was designed to evaluate the clinical effects of STX209 in 63 subjects, age 6-40 years, with a full mutation of the FMR1 gene. As previously reported, STX209 was well-tolerated and no metabolic side effects were observed. The most common adverse events in subjects receiving STX209 were upper respiratory infections (13%), sedation (8%) and headache (8%), compared to 10%, 2% and 2%, respectively, while receiving placebo. In per-protocol analyses, improvement was seen on the visual analog scale (VAS) ratings of parent-nominated problem behaviors and positive trends were observed on multiple global measures. While improvement was noted on the Irritability subscale of the Aberrant Behavior Checklist (ABC-I), the study's primary endpoint, the magnitude was comparable to that observed on placebo and did not achieve statistical significance.

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Contact: Kari Watson
kwatson@macbiocom.com
781-235-3060
MacDougall Biomedical Communications, Inc.
Source:Eurekalert

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