Seaside Therapeutics to announce arbaclofen trial results

Seaside Therapeutics has confirmed that it will reveal the results of its Phase 2b trial to evaluate arbaclofen as a treatment for autism spectrum disorder (ASD).

The company is working on study 209AS208, which is a randomised, double-blind, placebo-controlled Phase 2b study, which reviews the safety, tolerability and efficacy of the drug in 150 subjects with ASD.

Patients were randomised to receive either arbaclofen or placebo and were treated for 12 weeks. The study did not demonstrate improvement on the primary endpoint of social withdrawl, though it did show improvement on the Clinical Global Impression of Severity scale.

As well as this, secondary analyses of the information showed substantial improvement on the Vineland-II Socialization scale, which is a psycho-educational measure of social function.

Paul Wang, vice-president for clinical and medical affairs, said: “There currently are no FDA-approved therapeutics to treat the core impairments of ASD. These data represent an important advance towards addressing this serious unmet medical need.

“ASD is a heterogeneous disorder, in terms of its etiology and its clinical presentation. This study helps us better understand which patients with ASD respond most readily to treatment with arbaclofen.”

Seaside is aiming to confirm its results by starting another controlled trial of arbaclofen in patients with the condition.

The drug is an oral, selective gamma-aminobuytric acid type b (GABA-B) receptor against pathologies observed in particular neurodevelopment disorders, such as autism spectrum disorder and fragile X syndrome.

Arbaclofen has shown efficacy in preclinical models, indicating that the drug may improve functions in people with autism spectrum disorder and fragile X syndrome.

Seaside is set to carry out two phase 3 studies in fragile X syndrome in 2013, with one of these focusing on adults (aged 12 to 50) and one in children (aged five to 11).

Posted by Ben Evans