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fb001

Development stage: Unknown
Lead developer: Freya Biosciences
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: Vaginal

Overview

FB001 (also known as FRE01) is an investigational live biotherapeutic product (LBP) consisting of a donor-derived vaginal microbial consortium. Developed by Freya Biosciences, it is designed to restore a healthy, *Lactobacillus*-dominant vaginal microbiome in women with vaginal dysbiosis, including those with bacterial vaginosis (BV) or those undergoing infertility treatments such as IVF. The consortium aims to displace pathogenic bacteria associated with dysbiosis (e.g., *Gardnerella vaginalis*) and re-establish a protective acidic environment through the production of lactic acid and other metabolites. FB001 was evaluated in the FRE-01 clinical trial, which demonstrated its ability to achieve rapid and sustained engraftment of healthy microbiota. While Freya Biosciences is also developing FB301 specifically for bacterial vaginosis, FB001 remains the lead candidate for broader vaginal dysbiosis and reproductive health indications.

Other names: Vaginal Microbial Consortium

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