Drug intelligence / Profile preview

om-85 (OM Pharma)

Development stage
Phase 4
Lead developer
OM Pharma
Modality
Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Vaccines & Immunotherapeutics
Administration
Oral
01

Overview

OM-85 (marketed as Broncho Vaxom) is an oral immunostimulant composed of lyophilized bacterial lysates from multiple respiratory pathogens, including *Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Klebsiella pneumoniae* and others. It is used primarily for the prevention and treatment of recurrent respiratory tract infections and acute exacerbations of chronic bronchitis. The drug acts by modulating both innate and adaptive immune responses—stimulating cytokine production (such as IL-1, IL-6, TNF-alpha), activating dendritic cells via NF-kB and MAPK pathways (notably Erk1/2), enhancing B-cell activation (via BAFF and APRIL), increasing chemokine release to recruit immune effector cells (CXCL8/IL-8), promoting NK cell activity, and boosting mucosal immunity. These effects result in reduced frequency of respiratory infections and decreased antibiotic use in susceptible populations[1][4][6]. OM-85 is not approved in the United States but is widely used internationally.

Brand names
Broncho Vaxom
Other names
BVBroncho-Vaxom
02

Targets

NF-κB

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