Policy & Regulation
Pneumagen doses first participant in Neumifil phase two controlled human infection challenge study
17 August 2022 -

Pneumagen, a UK-based clinical stage biotech company, announced on Tuesday that it has dosed its first participant in its phase two controlled human infection challenge study of Neumifil, an intranasal, broad-spectrum antiviral treatment to prevent or, if infected decrease and handle viral respiratory tract infections.

The Phase two trial, a single centre, randomised, double-blinded, placebo-controlled study, is to assess two dose levels of Neumifil administered as an intranasal spray in healthy participants subsequently infected with flu virus. This clinical proof of concept study is to enrol up to 100 individuals and follows a successful Phase one trial for the product that produced positive topline data assessing safety and tolerability in healthy volunteers.

The latest study's primary endpoints are the decrease of the incidence of symptomatic influenza infection and the reduction of the severity of symptoms, thus evaluating the efficacy of the product, to offer an early treatment or prophylaxis option for at-risk patients with influenza. Secondary endpoints include an assessment of the decrease or shortening of viral shedding and reduction of nasal discharge.

hVIVO, an organisation involved in human challenge studies and a subsidiary of Open Orphan, will carry out the study. The trial will be conducted at its London facilities. Initial topline data are likely to be revealed in the first half of 2023.