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Escherichia coli strain M17

Development stage: Phase 3
Lead developer: BioBalance
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

Overview

ProBactrix is the brand name for a live biotherapeutic product containing the non-pathogenic Escherichia coli strain M17. It is being developed as a prescription biologic drug. [1, 2, 4] Originally developed by BioBalance Corporation, the asset was acquired by Enterologics, which intended to pursue FDA approval for specific gastrointestinal conditions as an alternative to long-term antibiotic use. [2, 3] An Investigational New Drug (IND) application is active with the FDA for the treatment of chronic pouchitis, a complication following surgery for ulcerative colitis. [2, 3] A clinical trial has also been conducted to assess its efficacy and safety in patients with gastroesophageal reflux disease (GERD). [6] The proposed mechanisms of action include the production of colicins (antibacterial compounds), competition with pathogens, and stimulation of the immune system. [7, 8]

Brand names: Probactrix

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