ENA Respiratory begins Phase I study on COVID-19

– First, fast-acting nasal spray designed to boost innate immunity against respiratory viruses, including SARS-CoV-2 and its variants, influenza and colds as the first portal of entry for most infections

– The company is recruiting study participants in the Sydney area, Australia

SYDNEY, Australia, July 13, 2021 (GLOBE NEWSWIRE) – ENA Respiratory, a biotechnology company developing a first-class nasal spray for the prevention of COVID-19 and other respiratory viral infections, today announced it has launched a phase I human safety study of INNA-051, under development to activate innate immunity in the nose, the main portal of entry for most respiratory viral infections. The quick-acting and convenient nasal spray could be used before or soon after exposure to a virus, prompting the body to respond more quickly to protect patients from the disease and reduce the chances of it spreading in the community.

“Vaccines have slowed the spread of COVID-19 in a number of countries, but the world remains at risk with the emergence of variants with increased transmissibility, like the Delta variant, first discovered in India. Being agnostic towards a specific virus or viral variant is one of the main potential characteristics of INNA-051 ”, said Christophe Demaison, Ph.D., co-founder and CEO of ENA Respiratory. “As we continue to fight current and emerging variants of the virus that causes COVID-19, there is a significant need for practical therapies that strengthen the protection of populations at risk 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 defense against COVID-19 and other respiratory viral infections. “

INNA-051 works by priming innate immunity in the nasal cavity to quickly clear viruses and other pathogens at the site of infection before they spread to other parts of the body.1 & 2 The epithelial cells that line the nasal cavity play a key role in detecting and initiating innate immune responses to threats from respiratory pathogens.3 In the case of COVID-19, innate immune responses are triggered within 48 hours of exposure to the virus and the onset of symptoms. In contrast, adaptive immunity that is triggered by vaccination or exposure to the virus and leads to the production of neutralizing antibodies takes about two weeks to establish.4

Preclinical studies have shown that INNA-051 works quickly. It has the potential to reduce the time it takes for nasal epithelial cells to initiate innate immune responses following exposure to the virus, providing an advantage to the body in its fight against the virus.

The Phase I study is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study. Its objective is to study the safety and tolerability of INNA-051 in healthy adults aged 18 to 55 years. The trial will also assess the pharmacokinetics and pharmacodynamics of therapy in study participants. It is being carried out at Scientia Clinical Research in Randwick, New South Wales, Australia. Amid a new COVID-19 outbreak in the Sydney area, the organization is actively recruiting people interested in participating in the study.

Previous research conducted by Public Health England (PHE) and published in the peer-reviewed journal EBioMedicine5 demonstrated that INNA-051 reduced viral replication by up to 96%. If the results of the benchmark animal study are replicated in humans, INNA-051 could be used to protect against COVID-19 after exposure to SARS-CoV-2 and its variants. Non-clinical studies also suggest that INNA-051 has the potential to protect against other viral illnesses, such as the flu and the common cold.

“As a broad spectrum therapy, INNA-051 could be used to reduce disease and the spread of other common viral infections that circulate in humans each year and cause millions of infections,” Demaison said. “The easy-to-use nasal spray could be useful in protecting populations at risk, such as the elderly or patients with chronic respiratory diseases. “

The first two cohorts of the phase I ascending single dose study have been successfully dosed and the study is expected to be completed by the third quarter of 2021. Recently, the company announced that it had secured additional funding. $ 24 million (A $ 32 million) from Brandon. Capital Partners and Minderoo Foundation, with a co-investment from Uniseed, to support the continued development of INNA-051.

ENDS

Notes to Editors

If you would like to arrange an interview, please contact:

About the Respiratory ENA and the INNA-051

ENA Respiratory aims to transform the treatment and prevention of respiratory viral infections in populations at risk. The company is based in Melbourne and Sydney, Australia.

INNA-051 is a potent innate immune agonist that targets the TLR2 / 6 receptor. It is being developed for intranasal administration to target the primary entry site for viral respiratory infections, as most respiratory viruses, including SARS-CoV-2 and influenza, initially infect and replicate in epithelial cells nasal mucosa which express TLR2 and TLR6 on their surface. Topical nasal administration of INNA-051 and related analogues has been shown in preclinical studies to protect treated animals against infections with SARS-CoV-2 (the causative agent of COVID-19), the virus of flu (flu) and rhinovirus (common cold). The main features of intranasal administration of INNA-051 include limited or no systemic bioavailability, minimal or no systemic release of pro-inflammatory cytokines, no direct upregulation of type I interferon, sustained immune response taking supports biweekly administration and compatibility with vaccine and intranasal corticosteroids.

For more information, please visit https://enarespiratory.com

The references:

  1. Girkin, J et al. Innate immune priming mediated by TLR2 enhances pulmonary antiviral 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 respiratory tract confers antiviral protection of the lungs. JCI Overview. 2021. 6 (5): e140267. https://doi.org/10.1172/jci.insight.140267
  3. Hewitt, RJ, Lloyd, CM Regulation of immune responses by the airway epithelial cell landscape. Nat Rev Immunol. 2021. 21, 347-362 https://doi.org/10.1038/s41577-020-00477-9
  4. Vetter, P et al. Daily viral kinetics and assessment of the innate and adaptive immune response in COVID-19: a case series. mSphere. 2020. 5 6. https://doi.org/10.1128/mSphere.00827-20.
  5. Proud PC et al. Prophylactic intranasal administration of a TLR2 / 6 agonist reduced upper respiratory viral excretion in a SARS-CoV-2 challenge ferret model. EBioMedicine. January 2021; 63: 103153. doi: 10.1016 / j.ebiom.2020.103153. Online publication of Dec. 2020

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/73dd9321-bca5-4abc-be71-255c08fc85ac

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5f941b60-2331-4005-8bbd-0768dcfd7ef3


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