Pneumagen Presents Positive Phase 2 Influenza Human Challenge Study data on Neumifil, its Broad-Spectrum Antiviral Drug, at the American Thoracic Society (ATS) 2024 Conference

  • Neumifil delivers statistically significant reductions in influenza symptomatic infection rate, symptom severity and viral load
  • Strategy to advance clinical development of Neumifil to be based on these positive data and pre-clinical data package demonstrating Neumifil’s activity against a broad range of viruses

St Andrews, UK – 23nd May 2024 – 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

 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 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

 

Pneumagen to Present Phase 2 Clinical Data on Neumifil, its Broad-Spectrum Antiviral, Intranasal Drug for Viral Respiratory Tract Infections, at ATS 2024

Data to be presented in oral and ePoster presentations

 St Andrews, UK – 2 May 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 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).

Pneumagen’s abstract is available on the ATS’s 2024 online programme:

Oral presentation details are as follows:

  • Title: HEX17, A Novel Broad-spectrum Antiviral Intranasal Drug, Demonstrates Efficacy Against Influenza in a Controlled Human Infection Model Conducted in Healthy Adults
  • Abstract Number: 6721
  • Mini Symposium: C18: Translating Science in Respiratory Infections
  • Date & Time: Tuesday May 21 at 9:15 AM – 11.15 AM EST
  • Location: San Diego Convention Centre, Room 6C-F (Upper Level)
  • Presenter: Geoff Kitson, Chief Medical Officer
  • https://www.abstractsonline.com/pp8/#!/11007/presentation/7604

ePoster presentation details are as follows:

  • Title: HEX17, A Novel Broad-spectrum Antiviral Intranasal Drug, Demonstrates Efficacy Against Influenza in a Controlled Human Infection Model Conducted in Healthy Adults
  • Date: Tuesday May 21 – Friday September 6 (available online between those dates)
  • Poster Session: Translating Science in Respiratory Infections
  • Authors: Geoff Kitson et al

***

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 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

 

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.”

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

 

Pneumagen raises £8m to accelerate Phase 2 clinical development of Neumifil for the prevention & treatment of viral respiratory tract infections

  • 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

St Andrews, UK – 1st June 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 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.”

For further information, please contact:

Pneumagen                                                                              

Douglas Thomson, CEO

Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)                             

Frazer Hall, David Dible, Sandi Greenwood, Evelyn McCormack

Email: Pneumagen@medistrava.com

 

Pneumagen further strengthens IP protection for lead product Neumifil with granting of US composition of matter patent

  • Neumifil is a novel intranasal spray being developed to provide those at-risk with an easy to use, broad-spectrum antiviral treatment to reduce and prevent respiratory disease exacerbations caused by viral infections
  • By directly targeting host cells in the nose, Neumifil blocks and prevents the entry of viral pathogens

 

St Andrews, UK 18 April 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 that the US Patent and Trademark Office (USPTO) has issued a US Patent for HEX17, the active pharmaceutical ingredient in Neumifil.

Neumifil, Pneumagen’s lead product, is being developed for the broad-spectrum prevention of viral induced exacerbations including those caused by influenza virus (IFV), respiratory syncytial virus (RSV), rhinovirus and coronavirus infections including COVID-19.

Neumifil is currently being evaluated in a Phase 2a proof of concept challenge study in healthy participants subsequently infected with influenza virus. A Phase 2 study, evaluating Neumifil in patients who are at high risk of viral induced exacerbations of their underlying disease, such as COPD, is due to start in 2024.

Neumifil’s active component, HEX17, is a multivalent, glycan-targeting carbohydrate binding module (mCBM). It was generated using Pneumagen’s proprietary GlycoTarge™ technology that identifies novel mCBMs for further development.

Douglas Thomson, CEO of Pneumagen, commented: “This US patent grant is a key milestone for Pneumagen, which builds further significant value for Neumifil, our novel first in class host cell-targeted antiviral. We are continuing to make excellent progress in developing this lead product and look forward to seeing further results from our clinical programme. The large patient population targeted by Neumifil presents a significant unmet need, given the limited treatment options available and the potentially fatal consequences of exacerbations of their underlying disease.”

Pneumagen has multiple patent families protecting its core intellectual property including granted US and European patents and has filed further patent applications covering the CBM technology, its application and medical use.

 

For further information, please contact:

Pneumagen                                                                              

Douglas Thomson, CEO

Email: info@pneumagen.com

 

MEDiSTRAVA Consulting (Financial PR)                             

Frazer Hall, David Dible, Sandi Greenwood

Email: Pneumagen@medistrava.com

Pneumagen appoints James Noble, a highly experienced biotech leader, as Chairman of its Board of Directors

St Andrews, UK 6 January 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), announces the appointment of James Noble as non-executive Chairman of its Board of Directors.

James brings over 30 years of industry experience to the Board from both public and private biotech and healthcare companies. He is currently Chairman at Orexo AB, Sutura Therapeutics and Celleron Therapeutics and non-executive director of Nasdaq listed company Lava Therapeutics N.V. He has previously held non-executive roles at several prominent biotech companies including MediGene AG, PowderJect, Oxford GlycoSciences, CuraGen, Advanced Medical Solutions and GW Pharmaceuticals.

In 2008, James founded Adaptimmune, a Nasdaq listed T-cell therapy company, where he worked as Chief Executive Officer until 2019 and is currently on the Board. Prior to that, he served as Chief Executive Officer of Immunocore, which he also co-founded. James holds an M.A. degree from the University of Oxford.

Douglas Thomson, CEO of Pneumagen, commented, “We are very pleased to welcome James to the Board who brings a wealth of strategic, corporate and financial expertise to Pneumagen. James’ considerable experience will be invaluable as we progress our Phase 2 clinical trial with our lead asset, Neumifil. We look forward to leveraging James’ global network and deep knowledge of the biotech sector as we continue our commitment to deliver an important new therapy to vulnerable patients at risk from viral RTIs.”

James Noble added “I am honoured to take on the role as Chairman of the Board of Directors at Pneumagen, a company that has already delivered highly encouraging early clinical data. I look forward to working closely with the company’s impressive team and driving forward the strategy to deliver such a potentially important new product for patients at high-risk of viral-induced exacerbations caused by respiratory viruses.”

For further information, please contact:

Pneumagen
Douglas Thomson, CEO
Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)
Frazer Hall, David Dible, Sandi Greenwood
Email: Pneumagen@medistrava.com

Pneumagen Creates International Clinical Advisory Group of World Leading Respiratory and Infectious Disease Experts

St Andrews, UK – 28 September 2022 – 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 the appointment of five world leading experts in respiratory and infectious diseases to its newly formed Clinical Advisory Group (CAG). The CAG will work closely with the Pneumagen management team to support its clinical development programmes, with an emphasis on the continued rapid and successful progress of its lead drug candidate, Neumifil.

The newly formed CAG will be chaired by Dr Charles Haworth, who will be joined by Professor James Chalmers, Professor Sanjay Haresh Chotirmall, Professor Peter Wark and Professor Kevin Winthrop.

“We believe that Neumifil has the potential to dramatically change the disease management landscape of patients with chronic lung disease at risk of viral induced exacerbations” said Dr Charles Haworth, Chairman of the CAG. “As a broad-spectrum antiviral, this novel treatment option has the potential to significantly reduce complications, hospitalisations and death for these patients who currently have limited options to prevent exacerbations of their condition.”

Douglas Thomson, CEO of Pneumagen, commented, “We are exceptionally pleased and honoured to have attracted such high-quality members to our newly created Clinical Advisory Group, all of whom are prominent experts in the fields of infectious and respiratory diseases. Their experience, insight and guidance will be crucial for the design of the Phase 2 study planned for 2023. In this study our lead product, Neumifil, will be evaluated as a novel treatment for patients who are at high risk of viral induced exacerbations of their underlying disease, such as COPD and bronchiectasis.”

The members of the Clinical Advisory Group are:

Dr Charles Haworth: Consultant Respiratory Physician, Cambridge Centre for Lung Infection at Royal Papworth Hospital England, he specialises in treating adults with cystic fibrosis, bronchiectasis and non-tuberculous mycobacterial (NTM) infections. He also serves as Honorary Consultant at Addenbrooke’s Hospital in Cambridge England.

Professor James Chalmers: Asthma and Lung UK Chair of Respiratory Research at the University of Dundee and Honorary Consultant physician at Ninewells Hospital Scotland. His clinical and research interests are in respiratory infections including pneumonia, COVID-19, bronchiectasis and COPD.

Associate Professor Sanjay Haresh Chotirmall: Current professional and academic roles include Associate Professor and Provost’s Chair of Molecular Medicine at the Lee Kong Chian School of Medicine, Nanyang Technological University Singapore where he also serves as Assistant Dean (Faculty Affairs). He is Consultant Respiratory Physician at Tan Tock Seng Hospital, Singapore and Visiting Reader at Imperial College London with clinical interests in bronchiectasis, complex infection and microbiome medicine.

Professor Peter Wark: Senior Staff Specialist in Respiratory and Sleep Medicine at John Hunter Hospital, Newcastle Australia, and a Conjoint Professor with the University of Newcastle Australia. In addition, he is a director of the Immune Health Programme at the Hunter Medical Research Institute.

Professor Kevin Winthrop: Director of the Center for Infectious Disease Studies in Portland, Oregon USA. Dr Winthrop is a Professor of Public Health at the School of Public Health and a Professor of Infectious Diseases and Ophthalmology at the School of Medicine at Oregon Health & Science University (OHSU). Prior to this, Dr Winthrop served as an infectious disease epidemiologist with the Division of Tuberculosis Elimination at the U.S. Centers for Disease Control and Prevention.

Neumifil is currently being studied in a controlled human infection model (CHIM).  This Phase 2, single centre, randomised, double-blinded, placebo-controlled study is evaluating the safety and efficacy of two dosing regimens of Neumifil, administered prophylactically as an intranasal spray to healthy participants, who then receive a controlled dose of flu virus. This clinical proof of concept study will enrol up to 100 individuals and follows a successful Phase 1 trial for Neumifil that produced positive preliminary data evaluating safety and tolerability in healthy volunteers.

For further information, please contact:

Pneumagen        

Douglas Thomson, CEO

Email: info@pneumagen.com

 

MEDiSTRAVA Consulting (Financial PR)      

Frazer Hall, David Dible, Sandi Greenwood

Email: Pneumagen@medistrava.com

Pneumagen Announces First Patient Dosed in Phase 2 Proof of Concept Influenza Challenge Study Assessing Neumifil, an Intranasal Broad-Spectrum Antiviral

St Andrews, UK – 16th August 2022 – Pneumagen, a clinical stage biotech company developing Neumifil, an intranasal, broad-spectrum antiviral treatment to prevent or, if infected reduce and manage viral respiratory tract infections, today announced that the first person has been dosed in its Phase 2 controlled human infection challenge study.

The Phase 2 trial is a single centre, randomised, double-blinded, placebo-controlled study evaluating two dose levels of Neumifil administered as an intranasal spray in healthy participants subsequently infected with flu virus. This clinical proof of concept study will enroll up to 100 individuals and follows a successful Phase 1 trial for Neumifil that produced positive topline data evaluating safety and tolerability in healthy volunteers.

The study’s primary endpoints are the reduction of the incidence of symptomatic influenza infection and the reduction of the severity of symptoms, thus assessing the efficacy of Neumifil, to provide an early treatment or prophylaxis option for at-risk patients with influenza. Secondary endpoints include an evaluation of the reduction or shortening of viral shedding and reduction of nasal discharge.

The trial will be conducted by hVIVO, a world leader in human challenge studies and subsidiary of Open Orphan, and will take place at its state-of-the-art London facilities. Initial topline data are expected in the first half of 2023.

Douglas Thomson, CEO of Pneumagen, commented, “We are thrilled to announce the initiation of this key Phase 2 influenza human challenge study, which is designed to deliver clinical proof of concept data with Neumifil. This Phase 2 study builds upon the promising data from our Phase 1 clinical trial.  Neumifil has the potential to prevent viral-induced exacerbations for patients at high risk of complications, reducing symptoms, hospitalisations and disease burden. This challenge study in healthy volunteers will help us prepare for a further Phase 2 trial starting in the second half of 2023 in patients who experience viral induced exacerbation of their underlying pulmonary pathology.”

For further information, please contact:  
Pneumagen       
Douglas Thomson, CEO
Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)    
Frazer Hall, David Dible, Sandi Greenwood
Email: Pneumagen@medistrava.com

End 

About Pneumagen
Pneumagen is a clinical- stage biotech company developing Neumifil, its lead product, as an intranasal drug for the prophylaxis and treatment of a broad range of viral respiratory tract infections (RTIs).
Neumifil is a novel, engineered multivalent Carbohydrate Binding Molecule (mCBM), which is being developed for the broad-spectrum prevention and treatment of Influenza Virus (IFV), Respiratory Syncytial Virus (RSV), and coronavirus infections including COVID-19. Neumifil acts by directly binding and preventing the entry of the viral pathogens into the host. Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ technology that identifies novel mCBMs for further development
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 RTI’s specifically related to glycobiology.
About hVIVO and Open Orphan plc
hVIVO, a subsidiary of Open Orphan plc, is a rapidly growing specialist contract research organization (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and longstanding client base of biopharma companies.

Pneumagen Announces Positive Top Line Results from Phase 1 Study Evaluating Neumifil, a Product Designed for the Prevention and Treatment of Viral Respiratory Tract Infections

  • Neumifil is a novel broad-spectrum anti-viral product that was shown to be well-tolerated with no safety signals at all doses tested
  • Pneumagen plans to conduct a Phase 2 Influenza challenge study in the second half of 2022 to demonstrate clinical proof of efficacy of Neumifil

St Andrews, UK – 12th May 2022 – 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 reports positive topline data from a Phase 1 study with Neumifil designed to evaluate safety and tolerability in healthy volunteers.

The Phase 1, single centre, two-part randomized, double-blind placebo-controlled dose escalation study enrolled a total of 60 healthy volunteers who were evaluated for safety and tolerability of single and multiple doses of Neumifil.

Top line data from the trial show that Neumifil is well tolerated with no dose limiting toxicities and a safety profile that strongly supports further development. No serious adverse events were reported at any of the doses evaluated in the study.

Dr. Geoff Kitson, Pneumagen’s Chief Medical Officer commented, “The availability of an effective intranasal broad-spectrum anti-viral therapeutic for patients who experience viral induced exacerbations of underlying pulmonary pathology would be transformational and would provide an early treatment option with significantly improved quality of life. This successful Phase 1 safety study is the first important step in our development path that could make Neumifil available to vulnerable and at-risk patients, offering them protection against a range of respiratory viruses.“

Neumifil is a unique multivalent carbohydrate binding molecule (mCBM) generated using Pneumagen’s proprietary GlycoTarge™ technology platform, that acts by binding to epithelial cell surface sialic acid receptors in the respiratory tract, thereby stopping viral entry at the site of infection by reducing their ability to enter host cells. Neumifil has shown potent anti-viral activity against a broad range of infections caused by influenza viruses, Respiratory Syncytial Virus (RSV), SARS-CoV-2 and rhinovirus in pre-clinical studies, and its differentiated mechanism of action means it is less susceptible to direct viral resistance.

Douglas Thomson, CEO of Pneumagen commented, “We are encouraged by these first clinical data, which confirm that Neumifil is well tolerated and safe. These data represent the first clinical evidence supporting the development of this new intranasal therapeutic for patients who experience viral induced exacerbations of chronic lung disease, including those with COPD and asthma. Neumifil has the potential to deliver a significant impact on decreasing the risk of hospitalization, complications and death for the many susceptible patients around the world.”

A Phase 2, proof of concept, controlled human influenza challenge study of Neumifil to be conducted by hVIVO is planned to commence in the second half of 2022. Following this trial, which is designed to demonstrate clinical proof of concept, Pneumagen plans to initiate full development studies in 2023, in patients who experience viral induced exacerbations of underlying pulmonary pathology.

 

For further information, please contact: 

Pneumagen                                                        

Douglas Thomson, CEO

Email: info@pneumagen.com

 

MEDiSTRAVA Consulting (Financial PR)    

Frazer Hall, David Dible, Sandi Greenwood, Evelyn McCormack

Email: Pneumagen@medistrava.com

 

About Pneumagen

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

Neumifil is a novel, engineered multivalent Carbohydrate Binding Molecule (mCBM), which is being developed for the pan-antiviral prevention of Influenza Virus (IFV), RSV, coronavirus infections including COVID-19 and human rhinovirus. Neumifil 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 to enter cells.

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.