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Gut-X-001

Development stage: Phase 2
Lead developer: Beijing Tiantan Hospital
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

Overview

Gut-X-001 is an investigational oral live biotherapeutic product (LBP) developed by Beijing Tiantan Hospital for the treatment of Alzheimer's disease. It is the lead candidate in the Metabolic ReConstruction (MRC) program, which focuses on therapeutic modulation of the gut-brain axis. Gut-X-001 is designed to alter the composition of the gut microbiota and the profile of microbial metabolites, which are hypothesized to influence systemic inflammation, oxidative stress, and neurodegenerative processes. The drug is currently being evaluated in the ESCAPE-AD clinical trial to determine its safety, feasibility, and preliminary efficacy in improving cognitive function and AD-related biomarkers in patients with Alzheimer's disease.

Other names: Metabolic ReConstruction Oral Biologics

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