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Neumifil - Pneumagen

Drug Profile

Neumifil - Pneumagen

Alternative Names: NeumifilTM

Latest Information Update: 30 Apr 2020

At a glance

  • Originator Pneumagen
  • Class Anti-infectives; Antivirals; Proteins
  • Mechanism of Action Epithelial cell modulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preclinical Influenza virus infections; Respiratory syncytial virus infections; Respiratory tract infections
  • Research COVID 2019 infections

Most Recent Events

  • 27 May 2020 Pneumagen plans a clinical trial for COVID-19 infections (Prevention, Treatment) in first half of 2021
  • 28 Apr 2020 Pharmacodynamics data from three in vitro studies in COVID-2019 infections released by Pneumagen
  • 28 Apr 2020 Pneumagen plans clinical development in COVID-2019 infections (Prevention, Treatment)

Development Overview

Introduction

Neumifil is a multivalent carbohydrate-binding module Family 40 domain (mCBM40) product derived from bacterial sialidases, being developed by Pneumagen (a spin-out from the University of St Andrews), for the treatment of respiratory tract infections (RTIs) including Influenza Virus (IFV) and Respiratory Syncytial Virus (RSV) and for the prevention and treatment of COVID-19 infections. The compound derived from Streptococcus pneumoniae masks the sialic acid receptors, thereby preventing the entry of the virus, providing the potential for universal protection against all RTIs that is independent of the immune response or the specific virus. mCBM40s have been shown to prevent and treat respiratory infections by masking epithelial cell surface sialic acid receptors present in the respiratory tract, used by several pathogens for entry and infection, via airways. The company plans to initially target high-risk groups such as the elderly, immuno-compromised and those with underlying lung disease such as asthma and COPD. Preclinical development is underway in the UK. Early research is underway for COVID-19 infections in the UK.

Neumifil™ is being developed from the company's proprietary GlycoTarge™ platform, wherein oligomers of the monomeric CBM40s are engineered genetically linking copies in tandem, with a trimerisation domain, resulting in multivalent proteins (mCBM40s) with a greatly increased binding affinity for sialic acid (sub nanomolar). The product offers an advantage of not being subject to viral resistance and being effective across multiple different viral strains including influenza viruses (IFVs), parainfluenza viruses, certain coronaviruses, enteroviruses and bacteria including Streptococcus pneumoniae.

Key Development Milestones

In April 2020, data from three separate in vitro studies, conducted in conjunction with Public Health England and University of Glasgow tackling COVID-2019 infections were released. Preclinical data from other studies were also released earlier in September 2019 [1] [2] .

Financing information

In May 2020, Pneumagen announced a GBP £4 million investment led by Thairm Bio with additional investment from the Scottish Investment Bank (SIB). The proceeds of the investments will be used for clinical development of Neumifil for the prevention and treatment of COVID-19 [3] .

Patent Information

In March 2010, Pneumagen has been granted with an international patent WO2010 029 312 A1, for compounds, compositions, medicaments and methods comprising or using carbohydrate binding molecules (CBM). The patent provides a means of treating diseases and/or conditions caused or contributed to by pathogens, particularly microbial pathogens and methods of screening, identifying, detecting tagging and/or labelling carbohydrates [4] .

Drug Properties & Chemical Synopsis

  • Route of administration Intranasal
  • Formulation unspecified
  • Class Anti-infectives, Antivirals, Proteins
  • Target Carbohydrate; Epithelial cell
  • Mechanism of Action Epithelial cell modulators
  • WHO ATC code

    J (Anti-infectives For Systemic Use)

    J05A-X (Other antivirals)

  • EPhMRA code

    J (General Anti-Infectives Systemic)

    J5B4 (Influenza antivirals)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Research United Kingdom unspecified / unspecified Pneumagen 17 Mar 2020
COVID 2019 infections - - Research United Kingdom unspecified / unspecified Pneumagen 17 Mar 2020
Influenza virus infections - - Preclinical United Kingdom Intranasal / unspecified Pneumagen 10 Sep 2019
Respiratory syncytial virus infections - - Preclinical United Kingdom Intranasal / unspecified Pneumagen 10 Sep 2019
Respiratory tract infections - - Preclinical United Kingdom Intranasal / unspecified Pneumagen 10 Sep 2019

Commercial Information

Involved Organisations

Organisation Involvement Countries
Pneumagen Originator England
Pneumagen Owner England
University of St Andrews Collaborator United-Kingdom
Public Health England Collaborator United-Kingdom
University of Glasgow Collaborator United-Kingdom

Scientific Summary

Pharmacodynamics

Summary

In preclinical proof-of-concept studies, intranasal Neumifil exhibited efficacy in RSV & IFV by significantly reducing replication of Respiratory Syncytial Virus in mice, a standard model for Respiratory Syncytial Virus (RSV) in humans, reduced key pro-inflammatory cytokines and the numbers of infiltrating immune cells, observed in all groups dosed either prophylactically or therapeutically with no observed toxicity [2] .

In plaque reduction assays, neumifil and other mCBMs curtailed the number of SARS-CoV-2 plaques, for both prevention and treatment of the infection [1] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2022 Trial Update Pneumagen plans a phase I trial in Influenza virus infections in 2022 (Intranasal) [5] 12 Sep 2019
30 Jun 2021 Trial Update Pneumagen plans a clinical trial for COVID-19 infections (Prevention, Treatment) in first half of 2021 [3] 01 Jun 2020

Development History

Event Date Update Type Comment
27 May 2020 Trial Update Pneumagen plans a clinical trial for COVID-19 infections (Prevention, Treatment) in first half of 2021 [3] Updated 19 Jun 2020
28 Apr 2020 Scientific Update Pharmacodynamics data from three in vitro studies in COVID-2019 infections released by Pneumagen [1] Updated 30 Apr 2020
28 Apr 2020 Trial Update Pneumagen plans clinical development in COVID-2019 infections (Prevention, Treatment) [1] Updated 30 Apr 2020
17 Mar 2020 Phase Change Early research in COVID-2019 infections (Prevention) in United Kingdom (unspecified route) Updated 19 Mar 2020
17 Mar 2020 Phase Change Early research in COVID-2019 infections in United Kingdom (unspecified route) Updated 19 Mar 2020
12 Sep 2019 Trial Update Pneumagen plans a phase I trial in Influenza virus infections in 2022 (Intranasal) [5] Updated 12 Sep 2019
10 Sep 2019 Phase Change - Preclinical Preclinical trials in Influenza virus infections in United Kingdom (Intranasal) [2] Updated 11 Sep 2019
10 Sep 2019 Phase Change - Preclinical Preclinical trials in Respiratory syncytial virus infections in United Kingdom (Intranasal) [2] Updated 11 Sep 2019
10 Sep 2019 Phase Change - Preclinical Preclinical trials in Respiratory tract infections in United Kingdom (Intranasal) [2] Updated 11 Sep 2019
10 Sep 2019 Scientific Update Preclinical pharmacodynamics data in Influenza virus infections and Respiratory syncytial virus infections released by Pneumagen [2] Updated 11 Sep 2019
18 Mar 2010 Patent Information Pneumagen has patent protection for carbohydrate binding molecules (CBM) in World [4] Updated 18 Sep 2019

References

  1. Pneumagen Ltd Announces Positive Anti-Viral Activity for Novel Glycan Approach in Preventing Coronavirus (COVID-19) Infections.

    Media Release
  2. Pneumagen Ltd Demonstrates Preclinical Proof-of-Concept for Neumifil(Tm) in Respiratory Syncytial Virus Infections.

    Media Release
  3. Pneumagen Announces 4m Fundraising and Commits to Clinical Trial Development for COVID-19.

    Media Release
  4. International patent WO2010029312A1 for CBM. Internet-Doc 2019;.

    Available from: URL: https://patentimages.storage.googleapis.com/ca/5a/dc/a27c22893bd81f/WO2010029312A1.pdf
  5. Pneumagen pipeline, September 2019. Internet-Doc 2019;.

    Available from: URL: https://www.pneumagen.com/pipeline.html
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