COVID-19 nasal spray trial seeks participants in Sydney
ENA Respiratory, an Australian biotech company developing a first-in-class nasal spray for the prevention of COVID-19, has initiated a Phase I human safety study in Sydney.
ENA Respiratory’s therapy, 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. Epithelial cells that line the nasal cavity play a key role in sensing and initiating innate immune responses to respiratory pathogen threats.
“Being agnostic to specific virus or viral variants is one of the potential key strengths of INNA-051,” said Dr Christophe Demaison, co-founder and CEO of ENA Respiratory.
“By stimulating the innate immune response, we hope to create an additional line of defence against COVID-19 and other respiratory viral infections.”
Shown in preclinical studies to be fast acting, INNA-051 has the potential to reduce the time required for nasal epithelial cells to initiate innate immune responses following virus exposure, providing an advantage to the body in its fight against the virus. In the case of COVID-19, innate immune responses are typically 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.
The therapy reduced COVID-19 replication by up to 96% in a peer-reviewed preclinical study performed by Public Health England (PHE) and published in the journal EBioMedicine. Now, the company is seeking 100 healthy Sydneysiders to participate in a Phase I human safety study which it hopes to complete by the end of September.
The Phase I study is a randomised, double-blind, placebo-controlled, single and multiple ascending dose study. Its goal is to investigate the safety and tolerability of INNA-051 in healthy adults aged 18 to 55 years old. The trial will also assess pharmacokinetics and pharmacodynamics of the therapy in study participants.
“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 ENA Respiratory 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.”
If results from the animal study carried out by PHE 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.
Sydneysiders who are interested in participating in the ENA Respiratory Phase I safety study can click here to find out more. Those successfully recruited into the study will be reimbursed for their time.
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