Pneumagen Announces First Patient Dosed in Phase 2 Proof of Concept Influenza Challenge Study Assessing Neumifil, an Intranasal Broad-Spectrum Antiviral

• Neumifil is a novel intranasal spray designed to provide at-risk patients with an easy-to-use broad-spectrum antiviral treatment to reduce, prevent and manage underlying disease exacerbations caused by viral infections
• The human challenge study will evaluate efficacy and safety of Neumifil in healthy participants infected with influenza

ST ANDREWS, Scotland, Aug. 16, 2022 /PRNewswire/ -- Pneumagen, a clinical stage biotech company developing Neumifil, an intranasal, broad-spectrum antiviral treatment to prevent or, if infected reduce and manage viral respiratory tract infections, today announced that the first person has been dosed in its Phase 2 controlled human infection challenge study.

The Phase 2 trial is a single centre, randomised, double-blinded, placebo-controlled study evaluating two dose levels of Neumifil administered as an intranasal spray in healthy participants subsequently infected with flu virus. This clinical proof of concept study will enroll up to 100 individuals and follows a successful Phase 1 trial for Neumifil that produced positive topline data evaluating safety and tolerability in healthy volunteers.

The study's primary endpoints are the reduction of the incidence of symptomatic influenza infection and the reduction of the severity of symptoms, thus assessing the efficacy of Neumifil, to provide an early treatment or prophylaxis option for at-risk patients with influenza. Secondary endpoints include an evaluation of the reduction or shortening of viral shedding and reduction of nasal discharge.

The trial will be conducted by hVIVO, a world leader in human challenge studies and subsidiary of Open Orphan, and will take place at its state-of-the-art London facilities. Initial topline data are expected in the first half of 2023.

Douglas Thomson, CEO of Pneumagen, commented, "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, hospitalisations 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."

For further information, please contact:

Pneumagen
Douglas Thomson, CEO
Email: info@pneumagen.com  

MEDiSTRAVA Consulting (Financial PR) 
Frazer Hall, David Dible, Sandi Greenwood
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 broad-spectrum prevention and treatment of Influenza Virus (IFV), Respiratory Syncytial Virus (RSV), and coronavirus infections including COVID-19. Neumifil acts by directly binding and preventing the entry of the viral pathogens into the host. Neumifil was generated using Pneumagen's proprietary GlycoTarge™ technology that identifies novel mCBMs for further development

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

About hVIVO and Open Orphan plc

hVIVO, a subsidiary of Open Orphan plc, is a rapidly growing specialist contract research organization (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and longstanding client base of biopharma companies.