Pneumagen’s intranasal flu antiviral has stood up to the challenge—a human challenge study, that is. The Scottish company has found that Neumifil reduced the symptomatic infection rate and severity of viral respiratory tract infections during a phase 2 proof-of-concept trial.
Neumifil was tested in a rare human challenge study, where volunteers are intentionally given an infection and carefully monitored. The midstage trial featured 104 healthy adults who received two doses of the intranasal treatment before they were exposed to the influenza virus.
The therapy showed a clinically significant reduction in the incidence of symptomatic flu infection and in symptom severity, meeting the main goal of the trial. Neumifil was well tolerated, and there were no treatment-emergent adverse events or safety signals of note compared to an earlier phase 1 study, the company said.
With the proof of concept in hand, Pneumagen now plans to advance more clinical trials for Neumifil, including to reduce viral exacerbations in patients with chronic obstructive pulmonary disease, or COPD. A phase 2b trial is expected to get underway in 2024.
Neumifil is the lead therapy for St. Andrews, U.K.-based Pneumagen, which spun out of the University of St Andrews in Scotland. The company announced 8 million pounds sterling ($9.6 million) in financing in June to support the clinical development program.