Drug intelligence / Profile preview

MaaT013

Development stage
Phase 3
Lead developer
MaaT Pharma
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
Rectal
01

Overview

MaaT013, branded as Xervyteg®, is a late-clinical-stage, pooled allogeneic fecal microbiotherapy developed by MaaT Pharma. It is classified as a Microbiome Ecosystem Therapy (MET) designed for acute, hospital use. [9, 10, 13] The therapy consists of a full-ecosystem, off-the-shelf, standardized suspension of diverse microbial species derived from multiple healthy donors, which is administered as an enema. [9, 10] Its mechanism involves restoring the gut microbiome's diversity and function to modulate the patient's immune system, control inflammation, and repair gut integrity. [1, 12] The primary indication for MaaT013 is the treatment of steroid-refractory gastrointestinal acute graft-versus-host disease (GI-aGvHD), a severe complication following allogeneic stem cell transplantation. [1, 6] It is also being investigated in a Phase 2 trial in combination with immune checkpoint inhibitors for metastatic melanoma. Following positive results from its pivotal Phase 3 ARES trial, MaaT Pharma has submitted a Marketing Authorization Application to the European Medicines Agency (EMA). [3, 6]

Brand names
Xervyteg
Other names
Microbiome Ecosystem Therapy

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