Pneumagen Announces Successful Clinical Proof of Concept for its Broad-Spectrum Antiviral Neumifil in Phase 2 Influenza Human Challenge Study
- Study achieves primary & secondary endpoints in a randomised, placebo-controlled challenge study
- Neumifil delivers a statistically significant reduction in both symptomatic infection rate & severity
- Favourable safety and tolerability profile
St Andrews, UK – 2nd October 2023 - 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 positive results from its Phase 2, Proof of Concept, Controlled Human Infection Model (CHIM) study where patients were challenged with influenza virus following administration of Neumifil.
Neumifil demonstrated a clinically significant reduction in the incidence of symptomatic influenza infection and in the severity of symptoms, which achieved statistical significance, compared to placebo. Neumifil was well tolerated with no new emergent adverse events or safety signals from the study compared to the first in human study.
The Phase 2, CHIM study, was a single centre, randomised, double-blind, placebo-controlled study in 104 healthy adults evaluating two dose regimens of Neumifil, administered as an intranasal spray to participants who were subsequently infected with influenza virus.
Based on these positive clinical results, taken together with a pre-clinical data package demonstrating Neumifil’s activity against a broad range of viruses, Pneumagen now plans to advance Neumifil into further clinical studies. This will include the evaluation of Neumifil’s ability to reduce the incidence of viral induced exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).
Douglas Thomson, Chief Executive Officer at Pneumagen said: “We are extremely pleased that this Phase 2, Proof of Concept study met all of its key objectives. The positive and clinically meaningful results we have delivered mark a critical step forward in the development of Neumifil and substantiate Pneumagen’s commitment to delivering a novel treatment option for patients suffering from virus induced exacerbations of respiratory diseases. These excellent results mean we can progress Neumifil with great confidence into further clinical studies to explore the efficacy and safety profile of our novel drug candidate in a larger at risk COPD patient population.”
