Pneumagen initiates Phase 1 trial of Neumifil, a novel, intranasal pan anti-viral therapeutic for the prophylaxis and treatment of viral Respiratory Tract Infections
St Andrews, UK – 10 November 2021 - Pneumagen, a clinical stage biotech company developing Neumifil, a universal, intranasal drug for the prophylaxis and treatment of viral respiratory tract infections (RTIs), announces the start of a Phase 1 study evaluating the safety and tolerability of single and multiple ascending doses of Neumifil in healthy volunteers. Pneumagen is developing Neumifil for a broad range of viral RTIs including influenza and COVID-19.
Initiation of this Phase 1 study is supported by preclinical studies that demonstrated prevention, treatment and post exposure prophylaxis of influenza viral infection and respiratory syncytial virus (RSV) infection, with no observed toxicity. Neumifil has also been shown to be efficacious against COVID-19, significantly reducing clinical signs in animal models.
Viral RTIs affect millions of people globally and are a leading cause of death around the world and a major burden on healthcare services. There is a clear need for new and improved options to tackle RTIs given the issues around influenza outbreaks, viral exacerbation of respiratory diseases such as asthma and COPD, together with the emergence of viruses with pandemic potential and the development of resistance to current anti-viral drugs.
“The start of this Phase 1 study is a major milestone for Pneumagen, and we are very pleased that we have made the step to become a clinical stage biotech company. We are extremely excited by the prospect of developing Neumifil as both a prophylactic and treatment for multiple viral respiratory tract infections, including influenza and COVID-19. As an easy-to-use nasal spray that could be prescribed to those at risk of viral exacerbations, Neumifil has the potential to prevent more serious disease, hospitalisation and the need for critical care for patients” said Douglas Thomson, CEO of Pneumagen. “Neumifil is being developed as a safe, effective and convenient to self-administer option with the potential to transform the treatment of viral pandemics and infectious diseases” he added.
The Phase 1 trial is a single center, two-part, randomized, double blind, placebo controlled, dose escalating study to assess the safety and tolerability of single and multiple doses of Neumifil in healthy volunteers. Part A aims to assess the safety and tolerability of single ascending intranasal doses of Neumifil, while Part B aims to assess the safety and tolerability of multiple-ascending intranasal doses of Neumifil.
Top line results from the study are expected in the first half of 2022.
Pneumagen is confident that Neumifil, as both a prophylactic and a treatment, could significantly expand the treatable RTI population given its ease of use, potential universal activity, and absence of exposure to direct viral resistance. Neumifil is a novel, engineered multivalent carbohydrate binding molecule (mCBM), generated using Pneumagen’s proprietary GlycoTarge technology that acts by stopping viruses at the site of infection, reducing their ability both to enter cells and to migrate to the lungs.
Pneumagen’s engineered mCBMs have been shown to prevent and treat viral RTIs by masking the epithelial cell surface sialic acid receptor glycans present in the respiratory tract which are used by many viral pathogens for entry and infection.
By directly preventing the binding and entry of pathogens, mCBMs have the advantage of being effective across multiple different viral types and strains including influenza viruses, parainfluenza viruses, respiratory syncytial virus and coronaviruses, including SARS-COV-2, and are not subject to direct viral resistance unlike other more conventional therapies.
In addition, Neumifil can have a dual mechanism of action, for instance in the treatment of COVID-19, where it can target and bind with high affinity to glycans on the viral spike protein that plays a key role in viral entry into the host cell, as well as targeting glycans on the angiotensin-converting enzyme 2 (ACE2) receptor on host cells, the human receptor for SARS-CoV-2.
Pneumagen has designed Neumifil to be simple and convenient to self-administer as a nasal spray and the aim is to develop a formulation that enables straightforward storage and distribution, eliminating the need for a cold chain.