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FB-001

Development stage: Phase 1
Lead developer: Kanvas 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: Oral

Overview

FB-001 is an investigational oral therapy developed by Federation Bio for the treatment of hyperoxaluria, including enteric hyperoxaluria. It consists of a defined consortium of 148 bacterial strains derived from multiple healthy donors. The drug is designed as a live biotherapeutic product intended to modulate the gut microbiome and reduce oxalate levels in patients with hyperoxaluria, a condition characterized by excessive urinary oxalate excretion that can lead to kidney stones and renal complications. FB-001 has undergone Phase 1 clinical trials evaluating its safety and tolerability in both healthy volunteers and patients with enteric hyperoxaluria[3][4]. Its mechanism of action involves altering the intestinal microbiota to enhance oxalate degradation, thereby reducing systemic oxalate burden.

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