UMSOM Initiates Phase 2 Trial for Novel Intranasal Spray Against Respiratory Viruses

Researchers at the University of Maryland School of Medicine's (UMSOM) Center for Vaccine Development and Global Health (CVD) have launched a Phase 2 clinical trial for an experimental intranasal spray. This spray is designed to enhance immune defenses and reduce illness caused by respiratory viruses.

The Broad Impact of Respiratory Illnesses

Approximately one million people in the U.S. were hospitalized last year for respiratory virus illnesses, including influenza and COVID-19, according to the Centers for Disease Control and Prevention (CDC). Many of these individuals faced an increased risk of infection, often due to exposure to young children.

Trial Design and Participant Enrollment

The study, a randomized double-blind trial, is being conducted in collaboration with ENA Respiratory, the manufacturer of the therapy. It aims to enroll 1,100 healthy adults aged 18 to 45. Participants are specifically selected if they are at heightened risk of upper respiratory virus infections due to frequent close contact or exposure to young children. They will receive either the investigational intranasal spray, named INNA-051, or a placebo spray.

How INNA-051 Functions: A Prophylactic Approach

INNA-051 is intended as a prophylactic, not a vaccine, and is designed for weekly use during cold and flu season. It acts as a TLR2/6 agonist, working to prime the immune system's initial defenses directly in the nasal passages. This mechanism may accelerate the clearance of pathogens before an infection can fully establish. Importantly, the spray is virus-agnostic, meaning it potentially offers protection against a wide range of respiratory viruses, including the flu, common colds, and COVID-19.

Expert Perspectives on the Therapy's Potential

"This study represents a novel approach to reducing respiratory infections by strengthening early immune defenses against multiple pathogens."

— Justin Ortiz, MD, Professor of Medicine and UMSOM Principal Investigator for the trial

"INNA-051 has the potential to protect vulnerable individuals, including those with chronic lung disease, heart disease, and diabetes."

— James Campbell, MD, MS, Professor of Pediatrics at UMSOM and Interim Director of the CVD

"TLR2/6 agonists represent a promising prophylactic therapy against respiratory viral illness. They aim to strengthen mucosal immune barriers and reduce viral transmission."

— Mark T. Gladwin, MD, UMSOM Dean