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SER-301

Development stage: Discontinued
Lead developer: Seres 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

**SER-301** is an investigational, orally administered, rationally designed live microbiome therapeutic developed by Seres Therapeutics for active mild-to-moderate ulcerative colitis. The product is a defined consortium of 18 cultivated human-commensal bacterial strains, delivered as capsules containing a spore-based component and a vegetative-bacteria component. It was designed to modify gastrointestinal microbiome functions and microbe-associated metabolites, dampen aberrant intestinal inflammation, promote immune homeostasis, and improve epithelial-barrier integrity. A Phase 1b study was initiated in Australia and New Zealand; the initial open-label cohort enrolled 15 participants, while Seres subsequently decided not to proceed with the planned placebo-controlled second cohort. ([businesswire.com](https://www.businesswire.com/news/home/20201106005080/en/Seres-Therapeutics-Announces-Initiation-of-Phase-1b-Trial-of-SER-301-for-the-Treatment-of-Ulcerative-Colitis))

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