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Mbiotix HBI Caps

Development stage: Preclinical
Lead developer: Human Biome Institute
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

Mbiotix HBI Caps is an oral fecal microbiota transplantation (FMT) preparation developed by the Human Biome Institute, a Polish biotechnology company and spin-off of the Medical University of Warsaw. The product consists of a full consortium of donor-derived intestinal microbiota (live biotherapeutic product) encapsulated in a specialized double-shell delivery system featuring acid-resistant and enteric coatings. This design ensures the targeted release of the microbiota in the ileocecal area of the gastrointestinal tract. Mbiotix HBI Caps is primarily indicated for the treatment of recurrent Clostridioides difficile infections (rCDI), where it has demonstrated clinical cure rates exceeding 90% by restoring the natural balance of the gut microbiome. The preparation is produced under quality assurance systems with the intent to meet Good Manufacturing Practice (GMP) standards for use in clinical trials and medical practice.

Brand names: Mbiotix HBI Caps
Other names: Mbiotix HBI Capsules

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