Clinical Advisory Group to advise on Pneumagen’s clinical development programme for Neumifil, a novel broad-spectrum antiviral intranasal spray. This will include the planned Phase 2 clinical trial in patients who are at high risk of viral induced exacerbations of their underlying disease, such as COPD and bronchiectasis.
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 announced the appointment of five world-leading experts in respiratory and infectious diseases to its newly formed Clinical Advisory Group (CAG). The CAG will work closely with the Pneumagen management team to support its clinical development programmes, with an emphasis on the continued rapid and successful progress of its lead drug candidate, Neumifil.
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.