Drug intelligence / Profile preview

OM-85 (OM Pharma, 4c7e20)

Development stage
Unknown
Lead developer
OM Pharma
Modality
Vaccines & Immunotherapeutics
Administration
Oral
01

Overview

OM-85 is an oral standardized bacterial lysate composed of lyophilized extracts from 21 strains of 8 common respiratory pathogens, including *Haemophilus influenzae*, *Streptococcus pneumoniae*, and *Staphylococcus aureus*. It acts as an immunomodulator by stimulating both innate and adaptive immune responses, primarily through the activation of Toll-like receptors (TLR2 and TLR4). This stimulation enhances airway epithelial barrier function, promotes antiviral properties, and induces immune tolerance. Marketed under brand names such as Broncho-Vaxom and Broncho-munal, it is indicated for the prevention of recurrent respiratory tract infections (RTIs) and acute exacerbations of chronic bronchitis. The Fondazione Policlinico Universitario Campus Bio-Medico is currently evaluating its efficacy in a Phase 4 clinical trial specifically targeting the reduction of lower RTIs in elderly nursing home residents aged 75 and older.

Brand names
Broncho-VaxomBroncho-munal
Other names
Bacterial lysateStandardized bacterial lysate
02

Targets

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

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