The once-weekly INNA-051 treatment from ENA Respiratory aims to prime the immune system to protect high-risk patients from influenza, RSV, and other respiratory viruses.
RT’s Three Key Takeaways:
- Phase II Progress: ENA Respiratory completed Part A of its Phase IIa study for INNA-051 and received endorsement to begin a larger Part B trial during the next respiratory virus season.
- Innate Immune Support: The virus-agnostic dry powder nasal spray works by priming the body’s natural defenses in the nose to enable a faster response to viral challenges.
- High-Risk Focus: The therapy is being developed to reduce complications in vulnerable populations, including the elderly and individuals with chronic lung conditions or other underlying medical issues.
ENA Respiratory has successfully completed Part A of its Phase IIa community study of INNA-051, a dry powder nasal spray designed to minimize the impact of symptomatic viral respiratory infections. Following a safety review, the study is now progressing to Part B.
The treatment is a virus-agnostic, once-weekly therapy that primes natural antiviral host defenses in the nasal passages, where most respiratory viruses enter the body. By enhancing the innate immune response, the therapy aims to reduce the incidence and severity of complications in patients at higher risk of severe illness.
The study, known as POSITS, is evaluating the safety, tolerability, and efficacy of the treatment over a three-month period. Researchers are assessing its impact on infections caused by common viruses, including influenza, respiratory syncytial virus (RSV), rhinovirus, and coronaviruses.
In Part A, 200 participants were recruited across five sites in the USA and completed four weeks of dosing. The Safety Review Committee identified no safety concerns and endorsed the progression to the next phase of the trial.
Part B will recruit 900 participants during the upcoming North American respiratory virus season. This phase will involve three months of dosing and will target individuals living or working in crowded environments, including military personnel, university students, and childcare workers.
“The successful completion of the first part of this Phase IIa study and the Safety Review Committee’s endorsement to progress to larger scale and longer dosing represent important milestones in the development of INNA-051,” said Ruth Tal-Singer, PhD, medicine development leader.
The lead product is being developed for populations at risk for severe complications, including the elderly and those with underlying medical conditions such as chronic obstructive pulmonary disease (COPD), diabetes, kidney disease, and cardiovascular disease.
INNA-051 is a potent agonist of toll-like receptor 2/6 (TLR2/6), which recognizes pathogens and boosts innate immune responses. In previous proof-of-principle studies using a human influenza-challenge model, the therapy demonstrated accelerated virus clearance and stimulation of antiviral host defenses.
