Drug intelligence / Profile preview

roseomonas mucosa

Development stage
Phase 2
Lead developer
Forte 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
Topical
01

Overview

**Roseomonas mucosa** is a topical live biotherapeutic product based on a commensal Gram-negative skin bacterium isolated from healthy volunteers and developed primarily for **atopic dermatitis**. In NIH/NIAID-led preclinical and clinical studies, live healthy-volunteer strains of *R. mucosa* reduced *Staphylococcus aureus* burden, improved barrier function and eczema severity, and showed persistence on skin after treatment cessation. Mechanistically, the therapeutic effect appears to be mediated mainly through production of beneficial bacterial lipids, including glycerophospholipid and sphingolipid-related mediators, with downstream promotion of epithelial repair pathways involving **TNFR2**, IL-8/CXCR2 signaling, cholinergic signaling via nicotinic acetylcholine receptors, and effects linked to TLR5/flagellin biology. The initial NIH Phase 1/2 BACTERiAD study was followed by development as **FB-401** under license to Forte Biosciences; however, a later placebo-controlled Phase 2b program did not meet its primary commercial endpoints, although post hoc analyses suggested modest benefit in protocol completers.

Other names
Roseomonas mucosaR. mucosaRoseomonas mucosa from healthy volunteersRmHVRSM2015RSM-2015RSM 2015
02

Targets

TNFR2 (Tumor necrosis factor receptor superfamily member 1B)

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