Neumifil - Pneumagen
Alternative Names: NeumifilTMLatest Information Update: 28 Oct 2023
At a glance
- Originator Pneumagen
- Class Anti-infectives; Antivirals; Proteins
- Mechanism of Action Epithelial cell modulators
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase II Influenza virus infections
- Phase I Respiratory tract infections
- Preclinical COVID 2019 infections; Respiratory syncytial virus infections
Most Recent Events
- 28 Oct 2023 No recent reports of development identified for preclinical development in Respiratory-syncytial-virus-infections in United Kingdom (Intranasal, Spray)
- 02 Oct 2023 Efficacy and adverse events data from a phase II trial in Influenza virus infections released by Pneumagen
- 04 May 2023 Pneumagen completes a phase-II clinical trial in Influenza virus infections in United Kingdom (Intranasal) (NCT05507567)
Development Overview
Introduction
Neumifil is a multivalent carbohydrate-binding module Family 40 domain (mCBM40) product derived from bacterial sialidases, intranasal spray 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. Clinical development in respiratory tract infections and influenza virus (IFV) is underway in the UK. Preclinical development for COVID-19 infections, respiratory syncytial virus and influenza virus (IFV) is underway 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.
As at October 2023, no recent reports of development had been identified for preclinical development in Respiratory-syncytial-virus-infections in United Kingdom (Intranasal, Spray).
Key Development Milestones
In October 2023, Pneumagen announced that Neumifil in phase II trial met its primary & secondary endpoints in a randomised, placebo-controlled challenge study. Earlier, in May 2023, Pneumagen completed the phase II trial that evaluated two dose levels of Neumifil in healthy participants subsequently infected with flu virus (NCT05507567; PNG-NMF-201). The randomised, double blinded, placebo controlled trial, initiated in August 2022, enrolled 104 healthy volunteers in the United Kingdom. In August 2022, first patient in the trial was dosed [1] [2] [3] . In October 2023, efficacy and safety data from phase II study in healthy volunteers were released by Pneumagen [4] .
In April 2022, Pneumagen completed phase I study that evaluated the safety and tolerability of single and multiple ascending doses of neumifil in healthy volunteers (NCT05093530; PNG-NMF-101). Part A aimed to assess the safety and tolerability of single ascending intranasal doses of Neumifil, while Part B aimed to assess the safety and tolerability of multiple-ascending intranasal doses of Neumifil. The single center, two-part, randomized, double blind, placebo controlled, dose escalating study was initiated in October 2021 and completed enrollment of 60 participants in May 2022, in the UK [5] . In May 2022, topline data from the study were released by Pneumagen. The company announced that, top line results from the study are expected in the first half of 2022 [6] [7] .
In November 2021, Pneumagen announced that, in preclinical studies, neumifil demonstrated prevention, treatment and post exposure prophylaxis of influenza viral infection and respiratory syncytial virus (RSV) infection, with no observed toxicity. Neumifil has also been shown to be efficacious against COVID-19, significantly reducing clinical signs in animal models [7] .
In March 2021, data from animal models infected with SARS-CoV-2 was released by Pneumagen [8]
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. In preclinical studies Neumifil demonstrated prevention, treatment and post-exposure prophylaxis of IFV and RSV infection with no observed toxicity [9] [10] .
Financing information
In June 2023, Pneumagen announced that it has secured £8 million in financing from existing and new investors to support the continued phase II development of Neumifil in Chronic Obstructive Pulmonary Disease (COPD) patients suffering from virus induced exacerbations [11] .
In January 2022, Pneumagen raised a further £3.8million to advance clinical development and manufacturing of Neumifil. The latest funding round brings total capital secured to date by Pneumagen to circa £14million and will enable the Company to advance further development of Neumifil into phase II, an influenza controlled human challenge study which will be conducted by hVIVO (subsidiary of Open Orphan) in the United Kingdom [12] .
Pneumagen announced a further £2.5 million investment from existing investors plus a new undisclosed global corporate investor based in the US. The investment will be used to support the clinical development of Neumifil™ in 2021 as an intra-nasal formulation for the prevention and treatment of influenza, respiratory syncytial virus (RSV) and COVID-19. This additional investment follows on from last year's announcement of a £4 million investment, and brings the total amount of financing raised to circa £9.5 million [13] .
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 [14] .
Patent Information
In April 2023, Pneumagen announced that the US Patent and Trademark Office (USPTO) has issued a US patent for HEX 17, the active pharmaceutical ingredient in Neumifil [15] .
As of April 2023, 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 [15] .
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 [16] .
Drug Properties & Chemical Synopsis
- Route of administration Intranasal
- Formulation Spray
- 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 | Preclinical | United Kingdom | Intranasal / Spray | Pneumagen | 10 Nov 2021 |
| COVID 2019 infections | - | - | Preclinical | United Kingdom | Intranasal / Spray | Pneumagen | 10 Nov 2021 |
| Influenza virus infections | - | - | Phase II | United Kingdom | Intranasal / Spray | Pneumagen | 16 Aug 2022 |
| Influenza virus infections | - | Prevention | Preclinical | United Kingdom | Intranasal / Spray | Pneumagen | 10 Nov 2021 |
| Respiratory syncytial virus infections | - | Prevention | Preclinical | United Kingdom | Intranasal / Spray | Pneumagen | 10 Nov 2021 |
| Respiratory syncytial virus infections | - | - | No development reported (Preclinical) | United Kingdom | Intranasal / Spray | Pneumagen | 28 Oct 2023 |
| Respiratory tract infections | - | In volunteers | Phase I | United Kingdom | Intranasal / Spray | Pneumagen | 13 Oct 2021 |
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
Adverse Events
In a phase I trial in healthy volunteers, neumifil was well tolerated with no dose limiting toxicities. No serious adverse events were reported at any of the doses evaluated in the study [6] [5] .
Influenza virus infections:
Phase II:
Safety data from phase II CHIM study for neumifil in healthy adults who were subsequently infected with influenza virus demonstrated that neumifil was well tolerated with no new emergent adverse events or safety signals from the study compared to the first in human study [4] [3]
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 [10] .
Preclinical data demonstrated significant reduction in clinical signs and weight loss in animal models infected with SARS-CoV-2. Neumifil was observed to bind with equally high affinity to spike proteins of Wuhan, UK and South African variants [8]
In plaque reduction assays, neumifil and other mCBMs curtailed the number of SARS-CoV-2 plaques, for both prevention and treatment of the infection [9] .
Therapeutic Trials
Influenza virus infections:
Phase II:
Efficacy data from phase II CHIM study for neumifil in healthy adults who were subsequently infected with influenza virus 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 [4] [3]
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2024 | Trial Update | Pneumagen plans a phase II trial for Chronic obstructive pulmonary disease in 2024 [15] | 21 Apr 2023 |
| 31 Dec 2023 | Trial Update | Pneumagen plans a second phase II trial in Influenza virus infections in H2 2023 (700357254) [2] | 04 Oct 2022 |
| 31 Dec 2022 | Trial Update | hVIVO plans a phase II trial in Influenza virus infections in H2 2022 (Intranasal) (9347757) [17] | 17 Aug 2022 |
| 30 Jun 2021 | Trial Update | Pneumagen plans a clinical trial for COVID-19 infections (Prevention, Treatment) in first half of 2021 [14] | 01 Jun 2020 |
| 30 Jun 2021 | Trial Update | Pneumagen plans a clinical trial for Respiratory syncytial virus infections, Influenza Virus infections and COVID-2019 infections (Prevention; Treatment) in mid 2021 (Intranasal) [13] | 20 Nov 2021 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Oct 2023 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Respiratory-syncytial-virus-infections in United Kingdom (Intranasal, Spray) Updated 28 Oct 2023 |
| 02 Oct 2023 | Scientific Update | Efficacy and adverse events data from a phase II trial in Influenza virus infections released by Pneumagen [4] Updated 04 Oct 2023 |
| 04 May 2023 | Trial Update | Pneumagen completes a phase-II clinical trial in Influenza virus infections in United Kingdom (Intranasal) (NCT05507567) Updated 30 May 2023 |
| 21 Apr 2023 | Patent Information | Pneumagen files for patent applications covering the CBM technology, its application and medical use [15] Updated 21 Apr 2023 |
| 19 Apr 2023 | Patent Information | Pneumagen has multiple patent protection for neumifil in USA and Europe [15] Updated 21 Apr 2023 |
| 19 Apr 2023 | Patent Information | USPTO issues a US patent for HEX17, the active pharmaceutical ingredient in Neumifil [15] Updated 21 Apr 2023 |
| 18 Apr 2023 | Trial Update | Pneumagen plans a phase II trial for Chronic obstructive pulmonary disease in 2024 [15] Updated 21 Apr 2023 |
| 28 Sep 2022 | Trial Update | Pneumagen plans a second phase II trial in Influenza virus infections in H2 2023 [2] Updated 05 Oct 2022 |
| 16 Aug 2022 | Phase Change - II | Phase-II clinical trials in Influenza virus infections in United Kingdom (Intranasal) [1] (NCT05507567) Updated 17 Aug 2022 |
| 12 May 2022 | Scientific Update | Adverse events data from phase I trial in healthy volunteers released by Pneumagen [6] Updated 18 May 2022 |
| 12 May 2022 | Trial Update | Pneumagen completes enrollment in a phase I trial in Respiratory tract infections (In volunteers) in United Kingdom (Intranasal) [6] Updated 18 May 2022 |
| 05 Apr 2022 | Trial Update | (Company) completes a phase I trial in Respiratory tract infections (In volunteers) in United Kingdom (Intranasal) (NCT05093530) Updated 02 Aug 2022 |
| 10 Nov 2021 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in United Kingdom (Intranasal) [13] Updated 20 Nov 2021 |
| 10 Nov 2021 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in United Kingdom (Intranasal) [13] Updated 20 Nov 2021 |
| 10 Nov 2021 | Phase Change - Preclinical | Preclinical trials in Influenza virus infections (Prevention) in United Kingdom (Intranasal) [7] Updated 20 Nov 2021 |
| 10 Nov 2021 | Phase Change - Preclinical | Preclinical trials in Respiratory syncytial virus infections (Prevention) in United Kingdom (Intranasal) [7] Updated 20 Nov 2021 |
| 13 Oct 2021 | Phase Change - I | Phase-I clinical trials in Respiratory tract infections (In volunteers) in United Kingdom (Intranasal) [13] (NCT05093530) Updated 20 Nov 2021 |
| 08 Mar 2021 | Scientific Update | Pharmacodynamics data from preclinical studies in COVID-2019 infections released by Pneumagen [8] Updated 15 Mar 2021 |
| 21 Jan 2021 | Trial Update | Pneumagen plans a clinical trial for Respiratory syncytial virus infections, Influenza Virus infections and COVID-2019 infections (Prevention; Treatment) in mid 2021 (Intranasal) [13] Updated 20 Nov 2021 |
| 27 May 2020 | Trial Update | Pneumagen plans a clinical trial for COVID-19 infections (Prevention, Treatment) in first half of 2021 [14] Updated 01 Jun 2020 |
| 28 Apr 2020 | Scientific Update | Pharmacodynamics data from three in vitro studies in COVID-2019 infections released by Pneumagen [9] Updated 30 Apr 2020 |
| 28 Apr 2020 | Trial Update | Pneumagen plans clinical development in COVID-2019 infections (Prevention, Treatment) [9] 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 | hVIVO plans a phase II trial in Influenza virus infections in H2 2022 (Intranasal) [12] [17] Updated 17 Aug 2022 |
| 10 Sep 2019 | Phase Change - Preclinical | Preclinical trials in Influenza virus infections in United Kingdom (Intranasal) [10] Updated 11 Sep 2019 |
| 10 Sep 2019 | Phase Change - Preclinical | Preclinical trials in Respiratory syncytial virus infections in United Kingdom (Intranasal) [10] Updated 11 Sep 2019 |
| 10 Sep 2019 | Phase Change - Preclinical | Preclinical trials in Respiratory tract infections in United Kingdom (Intranasal) [10] Updated 11 Sep 2019 |
| 10 Sep 2019 | Scientific Update | Preclinical pharmacodynamics data in Influenza virus infections and Respiratory syncytial virus infections released by Pneumagen [10] Updated 11 Sep 2019 |
| 18 Mar 2010 | Patent Information | Pneumagen has patent protection for carbohydrate binding molecules (CBM) in World [16] Updated 18 Sep 2019 |
References
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Pneumagen Announces First Patient Dosed in Phase 2 Proof of Concept Influenza Challenge Study Assessing Neumifil, an Intranasal Broad-Spectrum Antiviral.
Media Release -
Pneumagen Creates International Clinical Advisory Group of World Leading Respiratory and Infectious Disease Experts.
Media Release -
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
ctiprofile -
Pneumagen Announces Successful Clinical Proof of Concept for its Broad-Spectrum Antiviral Neumifil in Phase 2 Influenza Human Challenge Study.
Media Release -
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)
ctiprofile -
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.
Media Release -
Pneumagen initiates Phase 1 trial of Neumifil, a novel, intranasal pan anti-viral therapeutic for the prophylaxis and treatment of viral Respiratory Tract Infections.
Media Release -
Pneumagen Announces Neumifil(Tm) is Efficacious In an Established Model of COVID-19 Infection.
Media Release -
Pneumagen Ltd Announces Positive Anti-Viral Activity for Novel Glycan Approach in Preventing Coronavirus (COVID-19) Infections.
Media Release -
Pneumagen Ltd Demonstrates Preclinical Proof-of-Concept for Neumifil(Tm) in Respiratory Syncytial Virus Infections.
Media Release -
Pneumagen raises Lstg8m to accelerate Phase 2 clinical development of Neumifil for the prevention & treatment of viral respiratory tract infections.
Media Release -
Pneumagen Raises 3.8 million to Advance the Phase II Clinical Development of Neumifil, a Pan-antiviral, Intranasal Drug for the Prophylaxis and Treatment of Viral Respiratory Tract Infections (RTIs).
Media Release -
Pneumagen Announces 2.5m fundraising to advance universal treatment for viral respiratory infections into the clinic this year.
Media Release -
Pneumagen Announces 4m Fundraising and Commits to Clinical Trial Development for COVID-19.
Media Release -
Pneumagen further strengthens IP protection for lead product Neumifil with granting of US composition of matter patent.
Media Release -
International patent WO2010029312A1 for CBM. Internet-Doc 2019;.
Available from: URL: https://patentimages.storage.googleapis.com/ca/5a/dc/a27c22893bd81f/WO2010029312A1.pdf -
Pneumagen pipeline, September 2019. Internet-Doc 2019;.
Available from: URL: https://www.pneumagen.com/pipeline.html
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