ENA Respiratory Concludes Dosing for Older Adults in Phase Ib Trial

ENA Respiratory, a clinical-stage pharmaceutical firm focused on creating antiviral host defense immune boosters to reduce the effects of viral respiratory infections in vulnerable groups, reports that it has successfully finalized dosing for the older adult groups in its phase Ib trial of a dry powder version of INNA-051. Intranasal delivery of the new and more stable formulation of INNA-051 was well-accepted and resulted in local activation of innate immune pathways' gene expression.

The research aimed to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of INNA-051 delivered intranasally as a dry powder formulation, expected to have a shelf life exceeding two years at room temperature.

A total of thirty-two participants who were 60 years old or older took part in the study. Participants in the multiple ascending dose cohorts received weekly doses on three separate occasions, culminating with a maximum dose of 900 mcg (which is three times higher than the maximum dose used in the previous trial with the liquid formulation).

All doses of the treatment were well-tolerated, primarily showing mild, brief drug-related adverse events confined to the upper respiratory tract. The tolerability seen at these elevated doses resembles the profile noted in earlier clinical trials with the liquid nasal spray formulation. Analysis of biomarkers from nasal samples showed that treatment results in a notable local activation of innate immune pathways, including those for antiviral host defense, aligning with prior clinical observations.