Biotech company Pneumagen says the first person has been dosed in its phase 2 controlled human infection challenge study.
Its product, Neumifil, is an intranasal, broad-spectrum antiviral treatment to prevent or, if infected, reduce and manage, viral respiratory tract infections.
The phase 2 trial is a single center, randomized, double-blinded, placebo-controlled study evaluating two dose levels of Neumifil administered as an intranasal spray in healthy participants subsequently infected with flu virus.
This clinical proof-of-concept study will enroll up to 100 individuals and follows a successful phase 1 trial for Neumifil that produced positive topline data evaluating safety and tolerability in healthy volunteers.
Study endpoints
The study’s primary endpoints are the reduction of the incidence of symptomatic influenza infection and the reduction of the severity of symptoms, thus assessing the efficacy of Neumifil, to provide an early treatment or prophylaxis option for at-risk patients with influenza.
Secondary endpoints include an evaluation of the reduction or shortening of viral shedding and reduction of nasal discharge.
The trial will be conducted by hVIVO, a subsidiary of Open Orphan, and will take place at its London, U.K., facilities. Initial topline data are expected in the first half of 2023.
Douglas Thomson, CEO of Pneumagen, said: “We are thrilled to announce the initiation of this key phase 2 influenza human challenge study, which is designed to deliver clinical proof of concept data with Neumifil. This phase 2 study builds upon the promising data from our Phase 1 clinical trial.
“Neumifil has the potential to prevent viral-induced exacerbations for patients at high risk of complications, reducing symptoms, hospitalisations and disease burden. This challenge study in healthy volunteers will help us prepare for a further phase 2 trial starting in the second half of 2023 in patients who experience viral induced exacerbation of their underlying pulmonary pathology.”