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OM-85 is an oral immunostimulant composed of a standardized mixture of bacterial lysates derived from 21 strains across 8 species of common respiratory tract pathogens. It is primarily used to prevent recurrent respiratory tract infections (RTIs) and reduce exacerbations in chronic lung diseases such as asthma and COPD. The active components are obtained by alkaline or chemical lysis of bacteria including Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus pyogenes (including viridans group), and Moraxella catarrhalis. Mechanistically, OM-85 acts by stimulating both innate and adaptive immunity via the gut-lung axis. It promotes maturation of dendritic cells in Peyer’s patches leading to enhanced mucosal immune defense in the lungs. This results in upregulation of antiviral cytokines like interferon-gamma (IFN-γ), downregulation of Th2 cytokines (IL-4, IL-5, IL-13), reduction in IgE levels among allergic individuals, increased anti-inflammatory cytokine production (such as IL-10), and overall rebalancing toward a less inflammatory state[1][2][3][7][8]. OM-85 has been shown to reduce the frequency and severity of RTIs in children and adults with favorable safety comparable to placebo[1][3]. It may also have potential benefits for preventing COVID‑19 infection or complications[7], as well as reducing wheezing episodes/asthma development risk in children[4].
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