Pneumagen announced the initiation of a Phase 2 challenge study of its Neumifil multivalent carbohydrate binding module (mCBM) nasal spray, which is the company is developing as a universal treatment for influenza, RSV, and COVID-19. The Phase 2 trial is expected to enroll up to 100 subjects who will receive one of two dose levels of Neumifil or a placebo nasal spray and then will be infected with a flu virus. The primary endpoints for the study are reduction in the incidence of infection and reduction of symptom severity; secondary endpoints include reduction of nasal discharge and reduction of viral shedding. Topline data are expected by mid-2023.
In January 2022, Pneumagen said that it had closed a £3.8 million funding round to support Phase 2 development and GMP manufacturing of Neumifil. In May, the company announced positive results from a Phase 1 trial of the nasal spray.
Pneumagen CEO Douglas Thomson 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, hospitalizations 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.”
Read the Pneumagen press release.
