Neumifil (HEX17) / Pneumagen - LARVOL DELTA

A Phase II, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of HEX17, a Novel Broad-Spectrum Antiviral Drug, in a Controlled Human Infection Model of Influenza Challenge. (PubMed, Infect Dis Ther) - P2 | "Prophylactic HEX17 reduced the incidence of symptomatic influenza infection and may protect at-risk patients against influenza infection."

Journal • P2 data • Infectious Disease • Influenza • Respiratory Diseases

Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model (clinicaltrials.gov) - P2 | N=104 | Completed | Sponsor: Pneumagen Ltd. | Phase classification: P2a ➔ P2

Phase classification • Infectious Disease • Influenza • Respiratory Diseases

HEX17(Neumifil): an intranasal respiratory biotherapeutic with broad-acting antiviral activity. (PubMed, Antiviral Res) - "As described herein, HEX17 has demonstrated broad-spectrum efficacy against respiratory viral pathogens including IFV, RSV, CoV and HRV in multiple in vivo and in vitro studies. In addition, HEX17 can be easily administered via an intranasal spray and is currently undergoing clinical trials."

Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Influenza • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

HEX17, A Novel Broad-spectrum Antiviral Intranasal Drug, Demonstrates Efficacy Against Influenza in a Controlled Human Infection Model Conducted in Healthy Adults (ATS 2024) - "The results demonstrate that Neumifil is safe and well-tolerated, and, compared with placebo, is effective in reducing the incidence and/or the severity of symptomatic influenza infection. Based on these positive clinical results, taken together with a pre-clinical data package demonstrating Neumifil's activity against a broad range of viruses, Neumifil will be advanced into further clinical studies."

Clinical • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Influenza • Pulmonary Disease • Respiratory Diseases

Pneumagen to Present Phase 2 Clinical Data on Neumifil, its Broad-Spectrum Antiviral, Intranasal Drug for Viral Respiratory Tract Infections, at ATS 2024 (GlobeNewswire) - "Pneumagen...today announces that clinical results from a human challenge study with Neumifil (HEX17) will be presented at the 2024 American Thoracic Society (ATS) Conference, which will be held virtually and in person in San Diego, CA, May 17-22....The data will be presented in both oral and ePoster presentation sessions and will highlight important clinical results about the company’s proprietary drug, Neumifil. These will include the evaluation of Neumifil’s ability to reduce the incidence of viral induced exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD)."

Clinical data • Chronic Obstructive Pulmonary Disease

Pneumagen raises £8m to accelerate Phase 2 clinical development of Neumifil for the prevention & treatment of viral respiratory tract infections (GlobeNewswire) - "Pneumagen...today announced that it has secured £8 million in financing from existing and new investors to support the continued Phase 2 development of Neumifil in Chronic Obstructive Pulmonary Disease (COPD) patients suffering from virus induced exacerbations....Neumifil is currently being evaluated in a Phase 2a proof of concept human challenge study in healthy participants subsequently infected with influenza virus. Initial results are expected in mid-2023....'The funds will be used to support the continuing development of Neumifil, including preparing for a Phase 2b study in COPD patients which is planned to begin in 2024.'"

Financing • New P2b trial • P2 data • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model (clinicaltrials.gov) - P2a | N=104 | Completed | Sponsor: Pneumagen Ltd. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Use of a Preclinical Natural Transmission Model to Study Antiviral Effects of a Carbohydrate-Binding Module Therapy against SARS-CoV-2 in Hamsters. (PubMed, Viruses) - "Further refinements of the model are required in order to ensure the adequate transmission of the virus. However, our results provide additional data to the evidence base of Neumifil efficacy against respiratory virus infection and demonstrate that the transmission model is a potentially valuable tool for testing antiviral compounds against SARS-CoV-2."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model (clinicaltrials.gov) - P2a | N=100 | Recruiting | Sponsor: Pneumagen Ltd.

New P2a trial • Infectious Disease • Respiratory Diseases

Safety and Tolerability of Single and Multiple Doses of Neumifil (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Pneumagen Ltd. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Activity of a Carbohydrate-Binding Module Therapy, Neumifil, against SARS-CoV-2 Disease in a Hamster Model of Infection. (PubMed, Viruses) - "Furthermore, we demonstrate Neumifil binding to the human angiotensin-converting enzyme 2 (ACE2) receptor and spike protein of SARS-CoV-2. This is the first report describing the testing of this type of broad-spectrum antiviral therapy in vivo and provides evidence for the advancement of Neumifil in further preclinical and clinical studies."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Tolerability of Single and Multiple Doses of Neumifil (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Pneumagen Ltd.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Pneumagen announces £4m fundraising and commits to clinical trial development for covid-19 (P T) - "Pneumagen (Holdings) Ltd...today announced a GBP £4 million investment to allow the clinical development of Neumifil for the prevention and treatment of COVID-19....The investment will progress its lead candidate, Neumifil™ into a clinical trial for COVID-19."

Financing • New trial • Infectious Disease • Novel Coronavirus Disease