Author: Michael

The newly formed CAG will be chaired by Dr Charles Haworth, who will be joined by Professor James Chalmers, Professor Sanjay Haresh Chotirmall, Professor Peter Wark and Professor Kevin Winthrop.

“We believe that Neumifil has the potential to dramatically change the disease management landscape of patients with chronic lung disease at risk of viral induced exacerbations” said Dr Charles Haworth, Chairman of the CAG. “As a broad-spectrum antiviral, this novel treatment option has the potential to significantly reduce complications, hospitalisations and death for these patients who currently have limited options to prevent exacerbations of their condition.”

Douglas Thomson, CEO of Pneumagen, commented, “We are exceptionally pleased and honoured to have attracted such high-quality members to our newly created Clinical Advisory Group, all of whom are prominent experts in the fields of infectious and respiratory diseases. Their experience, insight and guidance will be crucial for the design of the Phase 2 study planned for 2023. In this study our lead product, Neumifil, will be evaluated as a novel treatment for patients who are at high risk of viral induced exacerbations of their underlying disease, such as COPD and bronchiectasis.”

The members of the Clinical Advisory Group are:

Dr Charles Haworth: Consultant Respiratory Physician, Cambridge Centre for Lung Infection at Royal Papworth Hospital England, he specialises in treating adults with cystic fibrosis, bronchiectasis and non-tuberculous mycobacterial (NTM) infections. He also serves as Honorary Consultant at Addenbrooke’s Hospital in Cambridge England.

Professor James Chalmers: Asthma and Lung UK Chair of Respiratory Research at the University of Dundee and Honorary Consultant physician at Ninewells Hospital Scotland. His clinical and research interests are in respiratory infections including pneumonia, COVID-19, bronchiectasis and COPD.

Associate Professor Sanjay Haresh Chotirmall: Current professional and academic roles include Associate Professor and Provost’s Chair of Molecular Medicine at the Lee Kong Chian School of Medicine, Nanyang Technological University Singapore where he also serves as Assistant Dean (Faculty Affairs). He is Consultant Respiratory Physician at Tan Tock Seng Hospital, Singapore and Visiting Reader at Imperial College London with clinical interests in bronchiectasis, complex infection and microbiome medicine.

Professor Peter Wark: Senior Staff Specialist in Respiratory and Sleep Medicine at John Hunter Hospital, Newcastle Australia, and a Conjoint Professor with the University of Newcastle Australia. In addition, he is a director of the Immune Health Programme at the Hunter Medical Research Institute.

Professor Kevin Winthrop: Director of the Center for Infectious Disease Studies in Portland, Oregon USA. Dr Winthrop is a Professor of Public Health at the School of Public Health and a Professor of Infectious Diseases and Ophthalmology at the School of Medicine at Oregon Health & Science University (OHSU). Prior to this, Dr Winthrop served as an infectious disease epidemiologist with the Division of Tuberculosis Elimination at the U.S. Centers for Disease Control and Prevention.

Neumifil is currently being studied in a controlled human infection model (CHIM).  This Phase 2, single centre, randomised, double-blinded, placebo-controlled study is evaluating the safety and efficacy of two dosing regimens of Neumifil, administered prophylactically as an intranasal spray to healthy participants, who then receive a controlled dose of flu virus. This clinical proof of concept study will enrol up to 100 individuals and follows a successful Phase 1 trial for Neumifil that produced positive preliminary data evaluating safety and tolerability in healthy volunteers.

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

St Andrews, UK – 16th August 2022 – 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

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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.