Drug intelligence / Profile preview

GUT-103

Development stage
Preclinical
Lead developer
Gusto Giusto
Modality
Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, 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

**GUT-103** is a rationally designed live bacterial consortium consisting of 17 metabolically interdependent strains isolated from healthy human stool samples, developed by Gusto Global for treating inflammatory bowel disease (IBD). It synergistically provides redundant therapeutic functionalities, including mucosal homeostasis, immune modulation, pathobiont competition via bacteriocins, short-chain fatty acid (SCFA) production like butyrate and propionate, and secondary bile acid metabolism (e.g., LCA, DCA), to restore functional gut microbiome dysbiosis in inflamed environments. In preclinical gnotobiotic and humanized mouse models of Th1/Th17-mediated colitis mimicking Crohn's disease, oral GUT-103 rapidly colonized the colon, outcompeted colitogenic pathobionts (e.g., adherent-invasive E. coli, Ruminococcus gnavus), reduced inflammation (e.g., lower IFNγ, IL-12p40, TNFα), promoted regulatory immunity (e.g., IL-10-producing T cells, Tregs), increased protective metabolites, and demonstrated both preventive and therapeutic efficacy by reversing established colitis without inducing inflammation.[1][2][3][5]

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