ENA Respiratory (ASK:ENA) has announced it has dosed the first participants in a Phase 2a flu-challenge study of its INNA-051.
INNA-051 is a first-in-class broad-spectrum antiviral innate immunomodulator for pre and post-exposure prophylaxis of respiratory viral infections in populations at risk of complications.
The Phase 2a trial is a single centre, prospective, randomised, double-blind, placebo-controlled study exploring two dose levels of INNA-051 administered as an intranasal spray to healthy adults. The trial will evaluate the safety, tolerability and antiviral efficacy of INNA-051 against H3N2 influenza virus infection.
The company said the study will enrol up to 123 participants.
Efficacy will be assessed based on the reduction of total viral load by RT-qPCR and total symptoms score in treated versus placebo participants.
“Patients at high-risk of complications from a respiratory viral infection, such as the elderly and those with pre-existing lung, cardiovascular, liver and kidney chronic diseases, urgently need therapies that help the body respond faster and reduce the risk of hospitalization or complications. This study will take us another step closer to determining whether INNA-051 can provide a fast-acting, easy-to-use therapy to address this unmet need,” said Christophe Demaison, a co-founder and CEO of ENA Respiratory.
The company said a Phase 2 COVID-19 post-exposure antiviral prophylaxis study to determine whether INNA-051 reduces the incidence and severity of symptomatic COVID-19 is also expected to begin shortly.