INNA-051

INNA-051
Clinical Trials

Acute upper and lower respiratory infections are a major public health problem and a leading cause of morbidity and mortality worldwide, particularly among at-risk populations such as older adults and individuals with underlying medical conditions, including chronic lung disease, diabetes, kidney disease, and cardiovascular disease.

At ENA Respiratory, we are committed to developing convenient, nasally administered preventive therapies that boost local host defences to stop respiratory viral infections in their tracks.

POSITS Study

A Study Assessing Safety, Tolerability, and Efficacy of INNA-051 in Preventing Respiratory Illness Due to Viral Infections in Healthy Adults 18 to 45 Years of Age

Locations: United States

Status: Recruitment for Part A of the study is complete. Recruitment for Part B of the study is scheduled to restart in mid-August 2026.

ClinicalTrials.gov Study ID: NCT07222670

Overview

A Randomized, Double-Blind, Two-Part, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of INNA-051 as Prophylaxis for Respiratory Tract Illness in Healthy Adults 18 to 45 Years of Age Who Are at Risk for Viral Respiratory Infections.

Protocol Summary

The aim of this clinical trial is to assess the safety of the investigational agent INNA-051, given intranasally, and its potential effectiveness in reducing the occurrence, severity, and/or duration of illness resulting from common respiratory virus infections, including influenza, rhinovirus, coronaviruses, and respiratory syncytial virus (RSV).

The trial is enrolling generally healthy adults (age 18 – 45 years) who are at risk of exposure to viral respiratory infections, for example, due to living conditions or occupation.

Participants are treated with INNA-051 or placebo once weekly for 4 weeks (Part A) or 12 weeks (Part B) during the respiratory virus season.

To learn more visit: https://clinicaltrials.gov/study/NCT07222670

Participant requirements

To participate in this study, you must be:

Resident in the USA
From 18 through 45 years of age
Healthy (without significant medical or psychiatric conditions)
At risk for exposure to viral respiratory infections, such as:
– Living in a crowded household, university dorm, or military barracks
– Working at a childcare center
– Living with children aged 10 or younger attending school or daycare
– Job-related exposure such as healthcare workers, factory workers, taxi and bus drivers, grocery clerks, and educators or counselors working in crowded environments or with multiple exposures with different people daily
There are other criteria that determine eligibility to join the study, find out more at:
https://clinicaltrials.gov/study/NCT07222670 or
https://positsclinicalstudy.com

We are recruiting at 5 locations in United States

Recruitment for Part A of the study is complete. Recruitment for Part B of the study is scheduled to restart in mid-August 2026.

See if you qualify - Visit POSITS study website

MARYLAND

Baltimore

Maryland, United States, 21201

Center for Vaccine Development and Global Health (CVD)

Bethesda

Maryland, United States, 20889

Naval Medical Research Command (NMRC)

North Carolina

Raleigh

North Carolina, United States, 27609

Accellacare of Raleigh

Statesville

North Carolina, United States, 28625

Accellacare of Piedmont HealthCare

Wilmington

North Carolina, United States, 20841

Accellacare – Wilmington

Phase 1 and 2a Trials: Completed

Previous First in Human clinical studies have demonstrated a favourable safety profile for INNA-051, supporting seasonal prophylaxis use.

In a phase 2a proof-of-principle study using a human influenza challenge model, INNA-051 accelerated viral clearance and stimulated antiviral host defences, including Interferon (IFN) Type I & III responses.

Read the published results from these trials

ERJ Open Research

View article

ENA Respiratory Announces Publication Supporting the Potential of its Novel Intranasal Therapy INNA-051 to Reduce the Impact of Viral Respiratory Infections in Older Adults

View press release

Resources

POSITS STUDY website

Clinical trial website

(intended for United States Residents only)

Visit website

Learn more about INNA-051

Mode of action video

View MoA video

NBC Washington news: Nasal spray could prevent respiratory viruses

View video

INNA-051 is an investigational drug product

INNA-015 is undergoing clinical studies to evaluate the safety and effectiveness in humans. It has not received marketing authorization or approval by any regulatory agency, including the US Food and Drug Administration, or the Australian Therapeutic Goods Administration and the European Medicines Agency.