[{"orgOrder":0,"company":"Allos Pharma","sponsor":"Seaside Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Allos Pharma Secures Exclusive License on Arbaclofen in Fragile X Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Allos Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Allos Pharma Inc. Presents New Positive Data Analyses at the 18th NFXF International Fragile X Conference","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Allos Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Allos Pharma Inc. Receives FDA Guidance for the Design of a Phase 3 Trial to Support a New Drug Application for Treatment of Fragile X Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"}]
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Arbaclofen selectively activates GABA-B receptors to decrease presynaptic release of excitatory neurotransmitters while simultaneously decreasing excitability of the postsynaptic neuron.
Clinically meaningful magnitudes of improvement were observed on all three ABCFX subscales for 45% of individuals receiving high dose of arbaclofen vs 4% treated with placebo (P=0.00003), clearly demonstrating efficacy of STX209 (arbaclofen) in individuals with Fragile X.
Arbaclofen is the active enantiomer of baclofen, a GABA-B receptor agonist. Statistically significant and clinically meaningful efficacy was observed in a prior Phase 3 trial conducted by Seaside Therapeutics in humans with Fragile X Syndrome.