Pneumagen Announces Positive Top Line Results from Phase 1 Study Evaluating Neumifil, a Product Designed for the Prevention and Treatment of Viral Respiratory Tract Infections

Pneumagen Announces Positive Top Line Results from Phase 1 Study Evaluating Neumifil, a Product Designed for the Prevention and Treatment of Viral Respiratory Tract Infections 

- Neumifil is a novel broad-spectrum anti-viral product that was shown to be well-tolerated with no safety signals at all doses tested 

- Pneumagen plans to conduct a Phase 2 Influenza challenge study in the second half of 2022 to demonstrate clinical proof of efficacy of Neumifil 

St Andrews, UK – 12^th May 2022 - Pneumagen, a clinical stage biotech company developing Neumifil, a broad-spectrum antiviral, intranasal drug for the prophylaxis and treatment of viral respiratory tract infections (RTIs), today reports positive topline data from a Phase 1 study with Neumifil designed to evaluate safety and tolerability in healthy volunteers. 

The Phase 1, single centre, two-part randomized, 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.  

Dr. Geoff Kitson, Pneumagen’s Chief Medical Officer commented, “The availability of an effective intranasal broad-spectrum anti-viral therapeutic for patients who experience viral induced exacerbations of underlying pulmonary pathology would be transformational and would provide an early treatment option with significantly improved quality of life. This successful Phase 1 safety study is the first important step in our development path that could make Neumifil available to vulnerable and at-risk patients, offering them protection against a range of respiratory viruses.“ 

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 anti-viral activity against a broad range of infections caused by influenza viruses, Respiratory Syncytial Virus (RSV), SARS-CoV-2 and rhinovirus in pre-clinical studies, and its differentiated mechanism of action means it is less susceptible to direct viral resistance. 

Douglas Thomson, CEO of Pneumagen commented, “We are encouraged by these first clinical data, which confirm that Neumifil is well tolerated and safe. These data represent the first clinical evidence supporting the development of this new intranasal therapeutic for patients who experience viral induced exacerbations of chronic lung disease, including those with COPD and asthma. Neumifil has the potential to deliver a significant impact on decreasing the risk of hospitalization, complications and death for the many susceptible patients around the world.”  

A Phase 2, proof of concept, controlled human influenza challenge study of Neumifil to be conducted by hVIVO is planned to commence in the second half of 2022. Following this trial, which is designed to demonstrate clinical proof of concept, Pneumagen plans to initiate full development studies in 2023, in patients who experience viral induced exacerbations of underlying pulmonary pathology.