Drug intelligence / Profile preview

lyophilized bacterial lysates

Development stage
Phase 3
Lead developer
OM Pharma
Modality
Microbiome-Derived Products → Microbiome Therapeutics
Administration
Oral
01

Overview

Lyophilized bacterial lysates, specifically the formulation known as **OM-85** (brand name **Broncho-Vaxom**), is an oral immunomodulatory biologic derived from the alkaline lysis of eight common respiratory bacterial pathogens: *Haemophilus influenzae*, *Streptococcus pneumoniae*, *Streptococcus pyogenes*, *Streptococcus viridans*, *Staphylococcus aureus*, *Klebsiella pneumoniae*, *Klebsiella ozaenae*, and *Moraxella catarrhalis*. The drug acts as a mucosal immunomodulator by stimulating the innate immune system through Toll-like receptors (TLR2 and TLR4), which in turn activates dendritic cells and alveolar macrophages. This process promotes a Th1-biased immune response and enhances the production of secretory IgA, effectively "training" the immune system to better resist respiratory infections. It is widely used globally to prevent recurrent respiratory tract infections in both pediatric and adult populations. Current clinical research, such as the Phase 3 PROTEA study, is evaluating its efficacy in preventing lower respiratory tract infections and wheezing in moderate-to-late preterm infants.

Brand names
Broncho-VaxomBroncho-MunalPaxoralVaxom
Other names
Bacterial lysateOM85OM-85OM 85
02

Targets

TLR2 (Toll-like Receptor 2)TLR4 (Toll-like receptor 4)

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