Drug intelligence / Profile preview

CP101

Development stage
Phase 2
Lead developer
Finch 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
01

Overview

CP101 is an investigational, orally administered, lyophilized microbiome therapeutic. It is a "Complete Consortia" product designed to deliver a diverse community of microbes derived from screened, healthy human donors to restore a healthy gut microbiome. [2, 9, 15] Originally developed at the University of Minnesota and in-licensed by Crestovo, it became the lead asset for Finch Therapeutics following a merger. While its Phase 3 trial (PRISM4) for the prevention of recurrent *Clostridioides difficile* infection was discontinued in January 2023 as part of a corporate restructuring, the asset is still being explored in other indications. [1, 4, 16] An investigator-sponsored Phase 1 trial is currently evaluating CP101 for the treatment of mild-to-moderate ulcerative colitis. [3, 5, 9]

Brand names
FSM®
Other names
Complete Consortia microbiome therapeuticFull Spectrum Microbiota

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