Drug intelligence / Profile preview

cap-FMT

Development stage: Unknown
Lead developer: University of Minnesota Medical School
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

Cap-FMT is a capsule-based fecal microbiota transplant (FMT) being developed by the University of Minnesota's Microbiota Therapeutics Program for the prevention of postoperative recurrence in adults with Crohn's disease. [6-13] The active ingredient is lyophilized FMT, with each capsule containing 5 x 10^11 bacteria. The treatment regimen involves a daily dose for five days, reaching a total of 2.5 x 10^12 bacteria. [6-4, 11] This product is classified as a microbiota-based therapeutic, a type of biological drug, which functions by modifying the gut microbiome rather than targeting a specific molecular pathway. A Phase 1 clinical trial (NCT05248191) is underway to compare the efficacy of the capsule formulation against FMT administered via colonoscopy in establishing beneficial bacteria in the gut of postoperative Crohn's disease patients. [6-13, 9, 11]

Other names: capsule-based fecal microbiota transplantcap-FMT-University of Minnesota-Crohn's disease

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