Safety tolerability and proof of pharmacology of a dry powder formulation of the antiviral host defense enhancer INNA-051 in healthy adults aged 18-80

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INNA-051 is a novel TLR2/6 agonist, developed as a once-a-week nasal dry powder targeting the primary entry site of viral respiratory infections. It acts as an innate immune enhancer, locally priming and boosting antiviral host defenses. A randomized, double-blind placebo-controlled Phase Ib study of a novel dry powder formulation with extended shelf life at RT was conducted to assess safety, tolerability, and local activation of immune pathways. Forty-eight participants aged 18 - 80 were enrolled, including 24 in multiple ascending dose cohorts dosed weekly on three occasions, with a maximum dose of 900 mcg. Treatment at all doses was well-tolerated, with mainly mild, short-duration drug-related AEs limited to the upper respiratory tract. The tolerability profile aligned with what has been previously observed with the liquid spray formulation. Gene expression was analyzed using the NanoString nCounter Human Pan-Cancer Immune Profiling panel from nasal swabs of INNA-051 and placebo-treated participants, collected up to 7 days post-dosing. This confirmed local activation of innate immune pathways, including antiviral host defenses (Figure; Pathway scores of older adults), consistent with prior studies. Results support progression to Phase 2 clinical development in individuals at risk of exposure to viral respiratory infections in a community setting. erj;66/suppl_69/PA3911/F1 F1 F1

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