FLAMOD (Nebulized Recombinant Flagellin): A Comprehensive Report on a First-in-Class Host-Directed Adjunct Therapy for Drug-Resistant Respiratory Infections

Executive Summary

FLAMOD is an investigational, first-in-class immunomodulatory biologic being developed as an adjunct therapy for severe respiratory infections, specifically targeting the escalating global crisis of antimicrobial resistance (AMR). The active pharmaceutical ingredient is a recombinant form of flagellin, a potent bacterial protein, which is administered as an aerosol directly to the lungs via a vibrating mesh nebulizer. This localized delivery is a key strategic element, designed to maximize therapeutic effect at the site of infection while minimizing systemic side effects.

The drug's mechanism of action is fundamentally different from conventional antibiotics. Instead of directly targeting the pathogen, FLAMOD functions as a host-directed therapy by stimulating the innate immune system. As a specific agonist of Toll-like receptor 5 (TLR5), it triggers a rapid, localized, and controlled immune cascade within the lung tissue. This response enhances the body's natural defenses, leading to the recruitment of neutrophils and the production of antimicrobial peptides, thereby augmenting the efficacy of co-administered antibiotics.