Pneumagen Announces Successful Clinical Proof of Concept for its Broad-Spectrum Antiviral Neumifil in Phase 2 Influenza Human Challenge Study

2023-10-02

临床2期临床结果

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.”

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About Pneumagen

Pneumagen is a clinical- stage biotech company developing Neumifil, its lead product, a broad-spectrum antiviral, intranasal drug for the prophylaxis and treatment of viral respiratory tract infections (RTIs).

Neumifil is expected to advance into further clinical studies in 2024.

Neumifil is a novel, engineered, multivalent, Carbohydrate Binding Module (mCBM). It acts by directly binding and preventing the entry into the host of the viral pathogens. Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ technology.

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 infections specifically related to glycobiology.

For further information, please contact:

Pneumagen

Douglas Thomson, CEO

Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)

Frazer Hall, Sandi Greenwood

Email: Pneumagen@medistrava.com

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