Drug intelligence / Profile preview

oxalobacter formigenes

Development stage
Phase 3
Lead developer
OxThera
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
01

Overview

Oxalobacter formigenes is a live biotherapeutic product being developed by OxThera under the brand name Oxabact®. It is an oral capsule containing a lyophilized (freeze-dried) formulation of the anaerobic bacterium *Oxalobacter formigenes*, which exclusively uses oxalate as its energy source. [3, 12, 16] The drug is intended for the treatment of Primary Hyperoxaluria (PH), a rare genetic disease characterized by the overproduction of oxalate, leading to kidney stones, nephrocalcinosis, and kidney failure. [2, 5] The mechanism of action is bimodal: the bacteria directly degrade oxalate within the gut, and they also produce secretagogues that stimulate the active secretion of oxalate from the bloodstream into the gut, further reducing the body's systemic oxalate burden. [7, 9, 14, 15] Clinical trials have evaluated its efficacy in reducing both plasma and urinary oxalate levels. [3, 11] While a Phase 3 study did not meet its primary endpoint with statistical significance, long-term extension studies have shown benefits. [13, 16]

Brand names
Oxabact
Other names
oxalobacter formigenes HC-1O. formigenes HC-1
02

Targets

SLC26A6 (Perilipin-5)

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