Goal is to add new medical countermeasure (MCM) against known and emerging viral respiratory threats
ENA Respiratory has been awarded a $4.38 million agreement from the U.S. Department of Defense to support ongoing research and development of INNA-051, a clinical stage broad-spectrum antiviral innate immunomodulator, administered intranasally for the prophylaxis of respiratory viral infections and their complications.
The agreement was awarded by the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in collaboration with the Defense Innovation Unit (DIU). Funding will support studies to develop an intranasal dry powder formulation of INNA-051 and scale-up manufacturing processes.
“Populations at high risk of exposure or complications continue to be significantly affected by influenza, SARS-CoV-2, RSV and other respiratory viruses, driving increased hospitalizations and health care utilization,” said Christophe Demaison, Ph.D., co-founder and CEO of ENA Respiratory. “This agreement with the DoD recognizes the necessity of developing a broad-spectrum and fast acting treatment to combat these debilitating viruses, and studying its use across a range of critical populations.”
The effort is expected to run for 12 months, paving the way to an Investigational New Drug (IND)-submission to the U.S. FDA aiming to support the Phase I bioequivalence study of an intranasal dry powder presentation of INNA-051. A dry powder formulation offers a number of advantages over the current spray solution formulation that will support deployment to distant or resource-limited settings and survival through the rigours of DoD logistics. INNA-051 was recently studied in a Phase 2a influenza challenge pre-exposure prophylaxis study, and results are expected soon. It was found to be well-tolerated in a Phase 1 study.
INNA-051 is a potent innate immune TLR2/6 agonist. It is currently in clinical development for self-administered intranasal delivery to target the primary entry site of viral respiratory infections as most respiratory viruses, including SARS-CoV-2 and influenza, initially infect and replicate in nasal mucosa epithelial cells. Fast-acting and inducing a durable biologic response supporting weekly administration, INNA-051 works by recruiting innate immune cells and priming epithelial cells of the nasal mucosa to respond more quickly to infections, rapidly eliminating viruses and other pathogens before they spread throughout the body. INNA-051 and close analogues have been shown in preclinical studies to be effective against multiple respiratory viruses, including SARS-CoV-2, influenza (H1N1 and seasonal H3N2), and rhinovirus.
Key features of INNA-051 intranasal administration include minimal or no systemic bioavailability, minimal or no systemic pro-inflammatory cytokine release, no direct type I interferon upregulation which is known to be associated with fever in humans, durable immune response supporting weekly administration, and compatibility with vaccine and intranasal corticosteroids.
Source: ENA Respiratory
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