A nasal spray invented by researchers from Telethon Kids Institute and The University of Western Australia to prevent childhood ear infections is being produced for human trials planned for 2025.
Lead inventor Associate Professor Lea-Ann Kirkham, a research microbiologist from Telethon Kids Institute, has worked on the therapy for 10 years. She said it had been shown to work in the laboratory and work was now underway to start clinical trials.
If successful, the spray could help prevent 700 million childhood ear infections globally a year, including severe infections that can lead to hearing loss. It could also slash millions of antibiotic prescriptions and surgeries to insert grommets, saving Australia $500 million a year.
The therapy aims to reduce the incidence of painful otitis media in young children by using ‘friendly bacteria’ to guard the ear from infection.
The Perth team is currently working out how often the spray would need to be given for optimal effectiveness but it envisages it would be suitable for any child at the onset of any respiratory infection to prevent the development of middle ear infections and in particular for those prone to infections or with a family history of ear infections.
Friendly bacteria shield
An institute video explains the low-cost spray, Spritz-OM, takes friendly bacteria commonly found in the noses of healthy children – and rare in children who suffer ear infections – and uses it like a probiotic for the nose, guarding the ear from infections and repeat infections and stopping respiratory viruses developing into bacterial ear infections.
The spray targets the major pathogen responsible for more than 50% of ear infections, Nontypeable Haemophilus influenzae (NTHi). NTHi is also a major pathogen in sinusitis, pneumonia and chronic lung diseases. There are no approved vaccines that successfully target the pathogen.
Kirkham and Professor Peter Richmond, a paediatric immunologist from Perth Children’s Hospital and head of the Telethon Kids Institute Vaccine Trials Group in the Wesfarmers Centre of Vaccines and Infectious Diseases, are leading the team. Richmond is also clinical advisor for the project, guiding product development for clinical trials.
Kirkham, who is co-head of the Bacterial Respiratory Infectious Disease Group at the centre, said the product was being made for trials which are planned to start next year.
Trials in adults, children and babies
“The first human trial will be in healthy adults to confirm safety before moving into a trial in children,” she told Hearing Practitioner Australia. “All children will be invited to participate, Aboriginal and non-Aboriginal. We will start with older children and move down in age to six months.
“The trials will involve placebo and we will monitor for up to six months, recording incidence of ear infections. We have strong community support for these trials to occur in Western Australia; many parents are looking forward to it.”
Kirkham said a $500,000 CUREator grant earlier in 2024 would springboard Spritz-OM toward trials to assess the nasal spray’s safety and efficacy for preventing ear infections.
More than 700 million children worldwide suffered an ear infection every year, she said on the institute website, and nearly every child suffered one by their second birthday. One in four experienced repeat infections, requiring antibiotics and often surgery to insert grommets.
“For Aboriginal children, this figure increases to one in two children,” she added.
Treatment costs $7.6 billion annually in the US
Globally, otitis media was the main reason children were prescribed antibiotics and underwent surgery with treatment costing $500 million a year in Australia and $7.6 billion annually in the United States.
“Ear infections are the main reason children are taken to see their GP, the main reason they are prescribed antibiotics and the main reason they undergo surgery at preschool age,” Kirkham told a CSIRO presentation.
If successful, the spray may also help curb the alarming rise in antimicrobial resistance by reducing consumption.
“Otitis media prevention would mean fewer GP visits, fewer antibiotics, and fewer surgeries, allowing redirection of healthcare resources and reduced antimicrobial resistance pressure,” she said.
“Socioeconomic value from otitis media prevention includes reduced absenteeism, improved hearing and educational outcomes, mitigation of health inequity, and enhanced wellbeing.”
CUREator is a national biotechnology incubator run by Brandon BioCatalyst to support development of Australia’s biomedical and research innovations. Funded by the Medical Research Future Fund and the CSIRO, CUREator provides grant funding for biomedical opportunities from discovery to clinical development.
It was one of five grants awarded as part of the Minimising Antimicrobial Resistance (AMR) stream of funding to target the growing threat of antimicrobial resistance. The World Health Organization says AMR is one of the biggest threats to global health.
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