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IBP-9414

Development stage: Phase 3
Lead developer: Infant Bacterial Therapeutics
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

IBP-9414 is a pharmaceutical-grade live biotherapeutic product containing the active substance *Lactobacillus reuteri*, a bacterial strain naturally found in human breast milk. [2, 3] It is developed by Infant Bacterial Therapeutics as a potential first-in-class treatment for premature infants. [5, 9] The drug has been evaluated in a large, global Phase 3 clinical trial ('The Connection Study') for the prevention of necrotizing enterocolitis (NEC) and for improving sustained feeding tolerance. [1, 12] While the trial did not meet its primary endpoints, it demonstrated a significant 27% reduction in all-cause mortality in infants treated with IBP-9414 compared to placebo. [2, 4] Based on this mortality data, the U.S. FDA granted IBP-9414 Breakthrough Therapy Designation in March 2025 for its potential to reduce gastrointestinal-related mortality in premature infants. [2, 10] The company plans to seek marketing approval in the U.S. and Europe. [11]

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