Sydney-developed COVID-19 nasal spray seeks trial participants

Australian biotech company ENA Respiratory is developing a first-in-class nasal spray for the prevention of COVID-19, which has entered a phase I human safety study in Sydney.

ENA Respiratory’s therapy, INNA-051, activates a person’s innate immunity in the nose, the primary entry portal of most respiratory viral infections. The treatment reduced COVID-19 replication by up to 96% in a gold-standard, peer-reviewed pre-clinical animal study published in EBioMedicine.

The company is seeking 100 healthy Sydneysiders to participate in its phase I human safety study which it hopes to complete by the end of September.

“Sydneysiders need no reminder of the continued threat COVID-19 poses to our way of life and participating in this clinical study is a way to contribute to the global fight against the pandemic,” said Dr Charlotte Lemech, Principal Investigator on the study and Medical Director at Scientia Clinical Research in Sydney.

“Despite the challenges of the current lockdown in Sydney, we have put in place additional safety procedures and our trial is continuing. We are seeking the support of any healthy adults aged 18–55 years to participate. We have dosed a number of cohorts so far and they are tolerating the therapy well.”

INNA-051 is a fast-acting and convenient nasal spray that could be used prior to, or shortly after, exposure to a virus, prompting the body to respond faster to protect patients from illness and reduce the chance of community spread.

“Vaccines have been slowing the spread of COVID-19 in a number of countries, but the world remains at risk, with the emergence of variants with increased transmissibility, such as the Delta variant, first discovered in India. Being agnostic to specific virus or viral variants is one of the potential key strengths of INNA-051,” ENA Respiratory co-founder and CEO Dr Christophe Demaison said.

ENA Respiratory co-founder and CEO Dr Christophe Demaison.

“As we continue to combat current and emerging COVID-19 variants, there is a significant need for convenient therapies that boost protection in at-risk populations, such as the elderly, and those with known COVID risk factors, such as obesity, diabetes and hypertension. By stimulating the innate immune response, we hope to create an additional line of defence against COVID-19 and other respiratory viral infections.”

INNA-051 works by priming the innate immunity in the nasal cavity to rapidly eliminate viruses and other pathogens at the site of infection before these spread to other parts of the body.^1,2 In the case of COVID-19, innate immune responses are triggered within 48 hours following virus exposure and symptom onset. By contrast, the adaptive immunity which is triggered by vaccination or virus exposure and leads to the production of neutralising antibodies takes about two weeks to establish.³

If results from the gold-standard animal study are replicated in humans, INNA-051 could be used to protect against COVID-19 after exposure to it and its variants. Non-clinical studies also suggest INNA-051 has the potential to protect against other viral illnesses, such as influenza and the common cold.

“As a broad-spectrum therapy, INNA-051 could be used in reducing illness associated with other common respiratory viruses, such as flu or common cold that circulate annually,” ENA Respiratory Chairman Dr Chris Smith said. “The easy-to-use nasal spray could be helpful in protecting at-risk populations, such as the elderly or patients with chronic respiratory diseases.”

Those from the Sydney region who are interested in participating the ENA Respiratory phase I safety study can find out more here. Those successfully recruited into the study will be paid for their time.

References

1. Girkin, J et al. TLR2-mediated innate immune priming boosts lung anti-viral immunity. European Respiratory Journal. 2020. 2001584; DOI: 10.1183/13993003.01584-2020
2. Deliyannis, G. et al. TLR-mediated activation of innate responses in the upper airways confers antiviral protection of the lungs. JCI Insight. 2021. 6(5):e140267. https://doi.org/10.1172/jci.insight.140267
3. Vetter, P et al. Daily Viral Kinetics and Innate and Adaptive Immune Response Assessment in COVID-19: a Case Series. mSphere. 2020. 5 6. https://doi.org/10.1128/mSphere.00827-20.