Drug intelligence / Profile preview

ABI-M301

Development stage: Preclinical
Lead developer: Assembly Biosciences
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-M301 is a preclinical microbiome-based therapeutic candidate developed by Assembly Biosciences for the treatment of Crohn's disease. It is a live biotherapeutic product (LBP) designed to modulate the gut microbiota to address gastrointestinal inflammation. The candidate utilizes Assembly's proprietary GEMICEL® oral delivery technology, a pH-sensitive, capsule-in-capsule system engineered for the targeted release of live bacteria to specific regions of the intestine. In 2017, Assembly Biosciences entered into a significant research and development collaboration with Allergan to advance ABI-M301 and other microbiome programs. However, following AbbVie's acquisition of Allergan, the partnership was terminated in 2020 as part of a strategic portfolio decision, and worldwide rights to the program were returned to Assembly Biosciences.

Beyond the preview

Go deeper on ABI-M301.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Follow clinical development from study design and recruitment through results.

Trial phase
Status
Readouts

Indications & development

Explore development by indication, patient population, and geography.

Indications
Development status
Countries

Licensing & deals

Trace asset ownership, licensing agreements, and commercial partnerships.

Partners
Deal terms
Milestones

Patents & exclusivity

Explore the patent landscape and regulatory exclusivity around an asset.

Patents
Expiration dates
Exclusivity

Competitive landscape

Compare development programs by target, modality, and indication.

Competing assets
Targets
Development stage

Research & analysis

Connect source evidence and development news to your research questions.

Publications
News
Analysis

Bring the full picture into focus.

See how Gosset can support your research on ABI-M301.

Explore the full profile