Drug intelligence / Profile preview

MB310

Development stage
Phase 1
Lead developer
Microbiotica
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

MB310 is an investigational **oral live biotherapeutic product** from Microbiotica being developed for **ulcerative colitis**. It consists of a **defined consortium of eight live gut commensal bacterial strains** formulated as capsules and is intended as a **once-daily precision microbiome therapy** designed to induce long-term remission without immunosuppression. MB310 was derived from analysis of clinical and microbiome data from a **faecal microbiota transplantation** study in ulcerative colitis conducted with the **University of Adelaide**, where engrafting bacteria associated with clinical remission were identified and selected into the product. Preclinical data indicate that MB310 acts through multiple complementary mechanisms relevant to ulcerative colitis pathology, including **repair of the damaged gut epithelial barrier**, **modulation of inflammatory and immune-regulatory cytokine balance such as TNF and IL-10**, and **induction of regulatory T-cell responses**. Additional mechanistic work suggests individual strains may enhance barrier integrity through **nicotinic acid release**, **polyamine production**, and expression of a novel protein called **IZOR**. MB310 entered first-in-human clinical testing in the randomized, placebo-controlled, double-blind **Phase 1b COMPOSER-1** study in adults with active mild-to-moderate ulcerative colitis.

Other names
COMPOSER-1COMPOSER1COMPOSER 1
02

Targets

TNFA (Tumor necrosis factor alpha (soluble))IL10 (Interleukin-10)

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