A Randomized, Double-blind, Placebo-controlled, Phase 2a Study To Assess the Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza, Via a Human Viral Challenge Model in Healthy Adult Participants
Study to assess the efficacy and safety of a multiple dose regimen and a single dose regimen of intranasal Neumifil, administered prior to challenge with Influenza virus in healthy adult participants
A Two-part, Randomized, Double-blind, Placebo Controlled, Ascending Dose Study to Assess the Safety and Tolerability of Single and Multiple Doses of Neumifil (a Novel Drug Candidate With Potential for Treatment of COVID-19)
This is a Phase 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of Neumifil, administered intranasally.
Use of a Preclinical Natural Transmission Model to Study Antiviral Effects of a Carbohydrate-Binding Module Therapy against SARS-CoV-2 in Hamsters.
作者: Daniel Knott ; Rachel Fell ; Jane A Potter ; Samantha Yuille ; Franscisco J Salguero ; Victoria A Graham ; Roger Hewson ; David Howat ; Stuart D Dowall
The emergence of severe acute respiratory syndrome coronavirus (SARS-CoV-2) and its expansion to a worldwide pandemic resulted in efforts to assess and develop interventions to reduce the disease burden. Despite the introduction of vaccine programmes against SARS-CoV-2, global incidence levels in early 2022 remained high, demonstrating a need for the development of physiologically relevant models, which are essential for the identification of alternative antiviral strategies. The hamster model of SARS-CoV-2 infection has been widely adopted due to similarities with humans in terms of host cell entry mechanism (via ACE2), and aspects of symptomology and virus shedding. We have previously described a natural transmission hamster model that better represents the natural course of infection. In the present study, we have conducted further testing of the model using the first-in-class antiviral Neumifil, which has previously shown promise against SARS-CoV-2 after a direct intranasal challenge. Neumifil is an intranasally delivered carbohydrate-binding module (CBM) which reduces the binding of viruses to their cellular receptor. By targeting the host cell, Neumifil has the potential to provide broad protection against multiple pathogens and variants. This study demonstrates that using a combination of a prophylactic and therapeutic delivery of Neumifil significantly reduces the severity of clinical signs in animals infected via a natural route of transmission and indicates a reduction of viral loads in the upper respiratory tract. 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.
Activity of a Carbohydrate-Binding Module Therapy, Neumifil, against SARS-CoV-2 Disease in a Hamster Model of Infection
作者: Fell, Rachel ; Potter, Jane A. ; Yuille, Samantha ; Salguero, Franscisco J. ; Watson, Robert ; Ngabo, Didier ; Gooch, Karen ; Hewson, Roger ; Howat, David ; Dowall, Stuart
The rapid global spread of severe acute respiratory coronavirus 2 (SARS-CoV-2) has resulted in an urgent effort to find efficacious therapeutics. Broad-spectrum therapies which could be used for other respiratory pathogens confer advantages, as do those based on targeting host cells that are not prone to the development of resistance by the pathogen. We tested an intranasally delivered carbohydrate-binding module (CBM) therapy, termed Neumifil, which is based on a CBM that has previously been shown to offer protection against the influenza virus through the binding of sialic acid receptors. Using the recognised hamster model of SARS-CoV-2 infection, we demonstrate that Neumifil significantly reduces clinical disease severity and pathological changes in the nasal cavity. 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.
Study achieves primary & secondary endpoints in a randomised, placebo-controlled challenge studyNeumifil delivers a statistically significant reduction in both symptomatic infection rate & severityFavourable 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.” END 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: firstname.lastname@example.org
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Frazer Hall, Sandi Greenwood Email: Pneumagen@medistrava.com
With the proof of concept in hand, Pneumagen now plans to advance more clinical trials for Neumifil to reduce viral exacerbations in patients with chronic obstructive pulmonary disease.
Pneumagen’s intranasal flu antiviral has stood up to the challenge—a human challenge study, that is. The Scottish company has found that Neumifil reduced the symptomatic infection rate and severity of viral respiratory tract infections during a phase 2 proof-of-concept trial.
Neumifil was tested in a rare human challenge study, where volunteers are intentionally given an infection and carefully monitored. The midstage trial featured 104 healthy adults who received two doses of the intranasal treatment before they were exposed to the influenza virus.
The therapy showed a clinically significant reduction in the incidence of symptomatic flu infection and in symptom severity, meeting the main goal of the trial. Neumifil was well tolerated, and there were no treatment-emergent adverse events or safety signals of note compared to an earlier phase 1 study, the company said.
With the proof of concept in hand, Pneumagen now plans to advance more clinical trials for Neumifil, including to reduce viral exacerbations in patients with chronic obstructive pulmonary disease, or COPD. A phase 2b trial is expected to get underway in 2024.
Neumifil is the lead therapy for St. Andrews, U.K.-based Pneumagen, which spun out of the University of St Andrews in Scotland. The company announced 8 million pounds sterling ($9.6 million) in financing in June to support the clinical development program.
Neumifil is being developed for the prevention and treatment of virus induced exacerbations in patients with respiratory disease
Advancing Neumifil into a Phase 2b clinical study due to start in 2024
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 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.
Pneumagen secured the latest funds from existing investors, Thairm Bio and Scottish Enterprise, new investor Esperante Ventures, the directors, as well as several US based investors.
The latest funding round will enable the company to advance the clinical development of Neumifil for individuals with COPD 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.
Douglas Thomson, Chief Executive Officer at Pneumagen said: “We are very pleased to announce this funding from our existing and new investors. This financing speaks to their confidence in our strategy and the significant progress we have made. 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.”
Thairm Bio’s Mark Bamforth said, “We are delighted to continue our support for Pneumagen for the further development of Neumifil, which has a highly promising profile based on early pre-clinical and clinical data. We have been impressed by Pneumagen’s progress and believe Neumifil could address a large unmet medical need by preventing virus induced exacerbations, which can be potentially lethal for some patients suffering from serious underlying respiratory disease.”
“We are excited to make our initial investment in Pneumagen,” said Dean Slagel, Managing Director at Esperante Ventures. “We were attracted by the quality of Pneumagen’s leadership and multiple milestones that Douglas and the Pneumagen team have delivered as they work to position Neumifil as a treatment option for respiratory tract infections.”
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 a Phase 2b clinical study in 2024, to reduce the suffering from virus induced exacerbations.
Neumifil is a novel, engineered multivalent Carbohydrate Binding Molecule (mCBM). It acts by directly binding and preventing the entry of the viral pathogens into the lungs with reduced susceptibility to direct viral resistance. Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ technology that acts by stopping viruses at the site of infection, reducing their ability both to enter cells and to migrate to the lungs.
In addition to Neumifil, Pneumagen is harnessing its GlycoTarge™ platform to enable the development of a pipeline of intranasal therapies targeting other infectious lung 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 RTI’s specifically related to glycobiology.
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