Encouraging preliminary results from an ongoing phase 1 study have triggered the announcement of phase 2 studies for a first-in-class nasal spray to protect people from respiratory viral diseases such as COVID-19 and influenza.
Hunter Medical Research Institute (HMRI) and University of Newcastle respiratory researchers have played an integral role in developing the spray for Australian biotech company, Ena Respiratory.
The treatment, INNA-051, was developed to boost the natural innate immune system to fight viruses that cause the common cold and flu in the nose and throat to prevent severe lung disease. The compound also proved successful in reducing shedding of the virus that causes COVID-19 (SARS-CoV-2) in a pre-clinical study.
Ena Respiratory has engaged research partners PPD, Inc. to conduct a randomised COVID-19 postexposure study across several countries, to determine whether INNA-051 reduces the incidence and severity of symptomatic COVID-19 in people aged 18-55 who have had close contact with other COVID-19 positive people.
In parallel, Ena Respiratory will partner with hVIVO (part of Open Orphan plc) to evaluate the safety and efficacy of pre-exposure INNA-051 treatment in reducing viral load of influenza in experimentally infected adult volunteers. Both studies will begin in January 2022.
Associate Professor Nathan Bartlett from the University of Newcastle, and head of HMRI's Viral Immunology and Respiratory Disease group, welcomed the development. Associate Professor Bartlett has been working with Ena Respiratory for six years as a key advisor and research collaborator. Using HMRI seed funding, his team was researching INNA-051 prior to COVID-19.
"We discovered that INNA-051 is very effective at priming the airways to more rapidly and effectively respond to a viral infection," Associate Prof Bartlett said.
"HMRI's proof of concept data was instrumental in ensuring the treatment was ideally placed to be tested against the virus that causes COVID-19," he said.
The INNA-051 compound works by stimulating the innate immune system, the first line of defence against viruses. If successful in clinical trials, INNA-051 could complement vaccines, particularly where a vaccine is likely to be less effective such as the elderly, patients with chronic lung disease and the immunocompromised.
The Phase 1 study in Sydney to investigate safety and tolerability of single and multiple administrations of INNA-051 in healthy adults aged 18 to 85, will be complete early next year.
Director of HMRI, Professor Mike Calford said it was exciting to see more HMRI research making its way from the lab and into patients. "HMRI researchers continue to be at the forefront of translational research into treatments that improve people's wellbeing and save lives."
* HMRI is a partnership between the University of Newcastle, Hunter New England Health and the community.
