Pneumagen, a clinical-stage biotechnology company developing Neumifil, a broad-spectrum antiviral intranasal drug, has reported positive topline data from a phase 1 study designed to evaluate safety and tolerability in healthy volunteers.
The phase 1, single-entre, two-part randomised, double-blind, placebo-controlled dose escalation study enrolled a total of 60 healthy volunteers who were evaluated for safety and tolerability of single and multiple doses of Neumifil. Top line data from the trial show that Neumifil is well tolerated with no dose limiting toxicities and a safety profile that strongly supports further development. No serious adverse events were reported at any of the doses evaluated in the study.
Neumifil is a unique multivalent carbohydrate binding molecule (mCBM) generated using Pneumagen’s proprietary GlycoTarge technology platform, that acts by binding to epithelial cell surface sialic acid receptors in the respiratory tract, thereby stopping viral entry at the site of infection by reducing their ability to enter host cells. Neumifil has shown potent antiviral activity against a broad range of infections caused by influenza viruses, respiratory syncytial virus (RSV), SARS-CoV-2 and rhinovirus in preclinical studies, and its differentiated mechanism of action means it is less susceptible to direct viral resistance.