ENA Respiratory, a clinical-stage pharmaceutical company developing antivirals that enhance the body's natural viral defence mechanisms to minimise the impact of symptomatic viral respiratory infections, announced today that it has raised US$22.4m (AUD$34m) in its Series B financing.
The funding round was supported by existing investors Brandon Capital and Uniseed, with participation from Stoic Venture Capital. It also welcomed new international investment from the Gates Foundation and the previously announced contribution from Flu Lab.
The new funding will support the Phase II clinical development of INNA-051, ENA's virus-agnostic once-weekly dry powder nasal spray, which primes the natural antiviral host defences in the nose, where viruses like colds, flu, RSV and coronaviruses typically enter, enabling the body to respond more quickly when challenged. Preclinical and clinical studies conducted to date suggest that INNA-051 has the potential to shorten the duration of symptomatic infections, prevent progression to the lungs, and reduce complications.
The planned Phase II community study ('POSITS') will evaluate the safety, tolerability and efficacy of up to three months' treatment with INNA-051 and assess its impact on the incidence, duration and severity of symptomatic infections caused by common respiratory viruses, including influenza, RSV, rhinovirus, and coronaviruses in young adult participants at risk of illness due to living or working in crowded environments.
The study, which is due to start shortly, will recruit up to 1,100 participants and be conducted during the 2025-2026 North American respiratory virus season. Justin Ortiz, MD, MS, Professor of Medicine at the University of Maryland's renowned global health institution, CVDGH, and a global health physician scientist with expertise in respiratory virus protection and control, will lead as a Principal Investigator.
The INNA-051 therapy aims to reduce the incidence of complications in patients at higher risk of severe illness. Seasonal respiratory infections such as flu take a significant toll on health systems and the economy, driving costly hospitalisations and workplace absences. The impact is most significant for patients with underlying medical conditions like asthma, COPD, heart disease, kidney disease, diabetes, primary immunodeficiency and cancer, who face a much higher risk of complications, with over a million hospitalisations and up to 200,000 deaths in the U.S. in 2025 from respiratory-related viral infections.
ENA Respiratory's CEO, Christophe Demaison, PhD said: "This funding marks a major milestone for ENA Respiratory as we advance INNA-051 into a community Phase II trial. With an international investor syndicate and ongoing support from our Australian investors, we are now in a strong position to evaluate the impact of our once-weekly powder nasal spray, which stimulates the body's natural antiviral defences, in a community setting and moves us closer to bringing it to the patients who need it most. This is an exciting step forward in our mission to deliver a first-of-its-kind preventative option for safeguarding vulnerable populations and has the potential to ease the global burden of respiratory viruses."
Research by the patient advocacy group Global Allergy & Airways Patient Platform, supported by ENA, found strong interest in a convenient preventative option like INNA-051 among more than 3,000 U.S. adult respondents with relevant comorbidities. A majority of those who identify themselves as high risk for hospitalisation or emergency visits due to viral respiratory infections indicated that they would use a product such as INNA-051 once a week during the winter months.
These findings highlight a clear unmet need and potential high uptake for convenient therapies that can reduce hospitalisations, keep people healthier and ease pressure on health services.
Chris Smith, PhD, Non-Executive Director, ENA Respiratory and Brandon Capital partner, said: "Brandon Capital has supported ENA Respiratory since its earliest days because we recognised the potential of INNA-051 to transform the prevention and management of respiratory infections. With this new round of funding and the upcoming Phase 2 trial in the United States, ENA Respiratory is well on its way to delivering a therapy that could protect millions of vulnerable people worldwide."
