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, Scotland, May 12, 2022 /PRNewswire/ -- 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.

For further information, please contact:
Pneumagen 
Douglas Thomson, CEO
Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)
Frazer Hall, David Dible, Sandi Greenwood, Evelyn McCormack
Email: Pneumagen@medistrava.com

About Pneumagen

Pneumagen is a clinical- stage biotech company developing Neumifil, its lead product, as an intranasal drug for the prophylaxis and treatment of a broad range of viral respiratory tract infections (RTIs).

Neumifil is a novel, engineered multivalent Carbohydrate Binding Molecule (mCBM), which is being developed for the pan-antiviral prevention of Influenza Virus (IFV), RSV, coronavirus infections including COVID-19 and human rhinovirus. Neumifil acts by directly binding and preventing the entry of the viral pathogens into the lungs with reduced susceptibility to direct viral resistance. Neumifil was generated using Pneumagen's proprietary GlycoTarge™ technology that acts by stopping viruses at the site of infection, reducing their ability to enter cells.

In addition to Neumifil, Pneumagen is harnessing its GlycoTarge™ platform to enable the development of a pipeline of intranasal therapies targeting other infectious lung diseases.

Pneumagen was established in 2016 as a spin-out from the University of St Andrews in Scotland giving Pneumagen access to world-class scientific expertise and capabilities in viral RTI's specifically related to glycobiology.