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news.Seaside Therapeutics has initiated a Phase 3 study to evaluate the effects of STX209 (arbaclofen) on social impairment in adolescents and adults (ages 12 to 25) with fragile X syndrome (FXS), a neurodevelopmental disorder.
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The double-blind, placebo-controlled study is designed to measure the efficacy, safety and tolerability of STX209, an oral selective gamma-amino butyric acid type B (GABA-B) receptor agonist.
GABA-B receptors play an important role in modulating the release of glutamate and maintaining the optimal excitatory-inhibitory balance.
STX209 has demonstrated efficacy in preclinical models, suggesting that the functional deficits of individuals with FXS and autism spectrum disorders (ASD) may be ameliorated by modulating glutamate release and optimizing the ratio of excitatory to inhibitory neurotransmission.
STX209 has completed the randomized, blinded, placebo-controlled trial (Phase 2) in patients with FXS and an open-label Phase 2 exploratory trial in patients with ASD.
Seaside Therapeutics MD, president and CEO Randall Carpenter said the Phase 3 study in patients with FXS represents the first time that a drug candidate will be evaluated for a core symptom of FXS as the primary endpoint.
An additional Phase 3 study in children (ages 5 to 11) with FXS and a Phase 2b study in children, adolescents and adults (ages 5 to 21) with ASD are expected to begin in early summer 2011.