ENA, COPD Foundation Team Up on INNA-051 Antiviral Nasal Spray

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by Steve Bryson PhD |

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ENA Respiratory is developing its first-in-class, broad-spectrum antiviral nasal spray — known as INNA-051 — for populations at risk of developing complications from respiratory viral infections, including COVID-19.

Now, the Australian company is teaming up with the COPD Foundation, a nonprofit with a mission to improve the lives of those affected by chronic obstructive pulmonary disease (COPD) and other lung conditions, such as bronchiectasis and nontuberculous mycobacterial (NTM) lung disease, to advance INNA-051 in these patient populations.

“We are excited to partner with ENA Respiratory to advance the development of INNA-051,” Ruth Tal-Singer, PhD, COPD Foundation president and chief scientific officer, said in a press release. “Millions of people are impacted by chronic lung diseases and are at a greater risk of complications from common respiratory illnesses.”

Respiratory viral infections are associated with worsening of chronic lung conditions, including asthma and COPD — a chronic inflammatory lung disease in which the airways become blocked, leading to cough with mucus, wheezing, and shortness of breath.

Viruses that can worsen lung disease symptoms include rhinovirus, or the common cold, respiratory syncytial virus (RSV), influenza, and SARS-CoV-2, which causes COVID-19.

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The presence of these viruses has been linked with poor outcomes, including acute exacerbations — a sudden worsening of symptoms — hospitalization, and an increased risk of hospital readmission among chronic lung disease patients. As such, there is an unmet need for therapies that reduce the incidence and impact of respiratory infections.

According to ENA Respiratory, INNA-051 is the first of its kind antiviral nasal spray.

“There continues to be a need for convenient treatments that can be used over the winter months or after known short-term exposure to a respiratory virus, to reduce the incidence of acute exacerbations of patients with chronic lung diseases,” said Christophe Demaison, PhD, CEO of ENA Respiratory.

“People with chronic lung diseases continue to be impacted not just by the COVID-19 pandemic but by the resurgence of other common respiratory viruses,” Demaison said.

INNA-051 is a potent activator of the innate immune system, the body’s first line of defense against microbial infections. Delivered as a spray to the nasal cavity — the primary entry site of viral respiratory infections — the antiviral therapy can be given before or after an infection sets in.

The therapy is designed to recruit innate immune cells and prime epithelial cells that line the nasal mucosa to respond to viruses more quickly, rapidly eliminating them before they spread to the lungs and other parts of the body.

In cell-based and preclinical studies, INNA-051 and similar compounds were found to be effective against multiple respiratory viruses, including SARS-CoV-2, influenza, and rhinovirus, and worked rapidly — in less than a day — to prime the airways to respond to viral infections. The therapy triggered a sustainable response, which supports weekly administration, and was compatible with vaccines and intranasal corticosteroids.

“Our patient community surveys highlight an urgent need for treatments that prevent flare-ups triggered by viral infections, now more than ever,” Tal-Singer said. “This fast-acting nasal spray could be used before or shortly after virus exposure to help the body respond faster and reduce the chances of complications.”

ENA Respiratory reported that a Phase 1 safety study evaluating single and multiple doses of INNA-051 showed the therapy was well-tolerated; the company expects to release more data this year.

A Phase 2 trial (NCT05118763) is planned to confirm the antiviral potential of INNA-051 in up to 423 adults who had household contact with an individual with a confirmed SARS-CoV-2 infection. This study is not yet recruiting.

Another Phase 2 trial will test the therapy’s ability to prevent infection in an influenza challenge pre-exposure study.

This new partnership will add INNA-051 to the COPD Foundation’s COPD360Net pipeline, accelerating its clinical development program by accessing its global network of research centers, scientific expertise, and patient investigators.

“We are thrilled to partner with the COPD Foundation to support the clinical development of INNA-051 in chronic lung diseases,” Demaison said. “They bring significant scientific and medical expertise in addition to providing access to patient feedback on the adoption of INNA-051 by this patient population.”