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FB401

Development stage: Unknown
Lead developer: Freya Biosciences
Modality: Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics
Administration: Vaginal

Overview

FB401 is a clinical-stage microbial immunotherapy (live biotherapeutic product) developed by Freya Biosciences using its proprietary Dyscover™ multi-omics platform. It is designed to address local inflammation and immune dysregulation in the female reproductive tract by restoring a healthy, Lactobacillus-dominant vaginal microbiome. FB401 is being developed for the prevention of preterm birth, with bacterial vaginosis serving as the initial proof-of-concept patient population.

Targets

VDR (Vitamin D receptor)

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