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AB-2004
- Development stage
- Phase 2
- Lead developer
- Vertero Therapeutics
- Modality
- Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Small Molecules, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
- Administration
- Oral
01
Overview
AB-2004 is a first-in-class, small molecule therapeutic developed by Axial Therapeutics for the treatment of irritability associated with autism spectrum disorder (ASD). It targets the microbiome gut-brain axis by selectively sequestering certain neuroactive microbial metabolites in the gut before they can enter the bloodstream and reach the brain. This mechanism aims to reduce levels of key gut bacterial metabolites, such as 4-ethylphenyl sulfate (4EPS), which are implicated in ASD-related behaviors. The drug is formulated as an oral powder and has demonstrated strong safety and tolerability in clinical trials, with evidence suggesting improvements in co-occurring conditions like irritability and anxiety[1][2][3][4][5][6][8].
- Other names
- colon-targeted AB-2004
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