Drug intelligence / Profile preview

MH002

Development stage
Phase 2
Lead developer
MRM Health
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

MH002 is an orally administered, clinical-stage, live biotherapeutic product (LBP) being developed by MRM Health. [2] It consists of a rationally designed consortium of six well-characterized, commensal bacterial strains selected for their ability to address key mechanisms underlying inflammatory bowel disease (IBD). [7, 12, 14] The primary mechanism of MH002 is to restore balance to the gut microbiome. [14] The bacterial consortium is a significant producer of butyrate, a short-chain fatty acid that serves as a key energy source for colonocytes, helps restore intestinal barrier integrity, and exerts anti-inflammatory effects. [10, 13] MH002 is intended to induce remission through immunomodulation rather than immunosuppression. [11] The product is developed using MRM Health's proprietary CORAL® platform, which allows the entire six-strain consortium to be manufactured as a single drug substance. [7, 9] In April 2026, the U.S. FDA granted Fast Track designation to MH002 for the treatment of mild-to-moderate ulcerative colitis. [2]

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