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FB-301

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

FB-301 is a clinical-stage microbial immunotherapy being developed by Freya Biosciences. It is a live biotherapeutic product composed of a defined consortium of multiple Lactobacillus strains administered as a vaginal capsule. [2, 6] The therapy is designed to restore a healthy, Lactobacillus-dominant vaginal microbiome by displacing pathogenic bacteria and resolving local inflammation and immune dysregulation. [4, 6] FB-301 is being investigated for its potential to improve outcomes for women undergoing in-vitro fertilization (IVF) by correcting vaginal dysbiosis, which is linked to embryo implantation failure. [3] It is also in development for the treatment of bacterial vaginosis (BV). [2, 6] Clinical studies have shown FB-301 to be safe and well-tolerated, demonstrating the ability to modulate the vaginal microbiome and durably engraft the therapeutic strains without the need for antibiotic pre-treatment. [2, 4]

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