Pneumagen Presents Positive Phase 2 Influenza Human Challenge Study


PNEUMAGEN, a clinical stage biotech company developing Neumifil (HEX17), a broad-spectrum antiviral, intranasal drug for the prophylaxis and treatment of viral respiratory tract infections (RTIs), presented positive results from its Phase 2, proof-of-concept, Controlled Human Infection Model (CHIM) study in which healthy volunteers were challenged with influenza virus following administration of Neumifil. These data were featured during an oral presentation* at the American Thoracic Society (ATS) in San Diego on 21st May.

The presentation, entitled “HEX17, a Novel Broad-spectrum Antiviral Intranasal Drug, Demonstrates Efficacy Against Influenza in a Controlled Human Infection Model Conducted in Healthy Adults,” was delivered by Dr Geoff Kitson, Chief Medical Officer of Pneumagen.

“We are very pleased to present detailed data from our Phase 2 Clinical trial of Neumifil,” said Douglas Thomson, Chief Executive Officer of Pneumagen. “Based on these promising proof-of-concept results presented at ATS, that reinforce the clinically significant reduction in both the incidence and severity of symptomatic influenza infection, we now look forward to advancing Neumifil into further clinical studies where its broad spectrum of activity offers significant potential. These trials are expected to include the evaluation of Neumifil’s ability to reduce the incidence of exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD), which represents a significant at-risk population.”

Dr Geoff Kitson, Chief Medical Officer and presenting author, commented “Viral respiratory infection is of enormous global concern, particularly in patients with underlying pulmonary disease, in whom viral infections can induce exacerbations. The significant reductions in both symptoms and viral load, demonstrate the potential of this new antiviral drug not only to alleviate patients suffering but also to curtail the spread of virus within communities.

Neumifil’s activity in protecting against a broad range of viral infections shows it has the potential to become an important medicine for the prevention of exacerbations in people with COPD or asthma.”

Key highlights from the presentation delivered at ATS:

  • Randomised, double-blind, placebo-controlled study conducted at a single centre in the UK
  • Study in healthy adults evaluating two dosing regimens (single dose, 3 days before infection or three daily doses on the three days leading up to infection with influenza virus) of Neumifil, administered as an intranasal spray to participants who were subsequently infected with influenza virus
  • Neumifil demonstrated a clinically significant reduction in the incidence of symptomatic influenza infection
  • Neumifil significantly reduced viral load and severity of symptoms compared to placebo
  • Neumifil was well tolerated with a safety profile in line with data from the first in human study

Abstract 6721, Geoff Kitson, Marion Byford, Lindsey Cass, David Howat, Brigitte Koehn, Douglas Thomson

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