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OM-85-IN is an investigational intranasal formulation of OM-85, a standardized bacterial lysate developed by OM Pharma. OM-85 is composed of lyophilized alkaline extracts from 21 strains of 8 common respiratory bacterial species, including *Haemophilus influenzae*, *Streptococcus pneumoniae*, and *Staphylococcus aureus*. The drug acts as an immunomodulator by activating innate immune cells via Toll-like receptors (TLRs), particularly TLR2, TLR4, TLR7, and TLR9. This activation leads to the maturation of dendritic cells and a shift in the adaptive immune response from a pro-allergic Th2 profile toward a protective Th1 profile, while also enhancing regulatory T cell (Treg) activity. While the oral version of OM-85 (marketed as Broncho-Vaxom) is established for preventing recurrent respiratory infections, OM-85-IN is specifically being evaluated for its safety and efficacy in treating and preventing allergic asthma by targeting the airway mucosa directly.
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