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ABI-M201

Development stage: Discontinued
Lead developer: Xbiome
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

ABI-M201 is an investigational **oral live biotherapeutic product** developed by Assembly Biosciences for **mildly to moderately active ulcerative colitis**. It consists of a **rationally designed consortium of commensal bacteria** selected for their ability to modulate ulcerative-colitis-relevant cellular mechanisms in preclinical human cell-based assays and animal models. The product is delivered orally using Assembly's proprietary **Gemicel capsule-in-capsule system** for targeted gastrointestinal delivery. ABI-M201 entered a randomized, double-blind, placebo-controlled Phase 1b study in adults with ulcerative colitis receiving mesalamine, but the Allergan collaboration under which it was advanced was terminated in 2020, Assembly later wound down its microbiome program, and the ABI-M201-related assets were subsequently sold to an unnamed third party.

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