Official Title
A Phase 2, Two-part Study to Assess the Safety, Antiviral Biomarker Responses, and Efficacy of Inhaled SNG001 for the Treatment of Patients With a Confirmed Respiratory Virus Infection Undergoing Invasive Mechanical Ventilation
Brief Summary

The goal of this Phase 2 study is to assess about the safety, antiviral biomarkerresponses and efficacy of SNG001 when given to patients requiring invasive mechanicalventilation due to a respiratory virus infection. Its ability to speed up virus clearanceand reduce mortality, compared with standard of care, will be studied.The study is split into two parts. All participants will receive standard of care inaddition to SNG001 or placebo.In Part 1, the safety of SNG001 will be assessed. Participants of 50 years and older willreceive study drug or placebo once a day for up to 14 days, whilst in hospital.In Part 2, the primary objective will be the efficacy of SNG001. Participants between 18and 50 years with an immunocompromising condition and patients over 50 years (with orwithout an immunocompromising condition) will receive study drug once a day for up to 14days, whilst in hospital.

Detailed Description

Not Provided

Recruiting
Viral Pneumonia

Drug: SNG001

SNG001 nebuliser solution is presented as a ready-to-use aqueous solution (neutral pH) in
glass syringes containing 0.65 mL of drug product solution containing 12 MIU/mL of IFNβ
1a.

Drug: Placebo

The placebo nebuliser solution is presented in glass syringes containing 0.65 mL of
solution containing the same formulation as the study medication but without IFNβ 1a
(i.e., only the excipients of the SNG001 solution).

Eligibility Criteria

Part 1 Inclusion Criteria:

To be eligible for randomisation into Part 1 of this study, each participant must fulfil
the following criteria:

1. Informed consent or legal representative's consent obtained.

2. Patients ≥50 years of age at the time of consent.

3. Patient admitted to the ICU and requiring invasive mechanical ventilation (IMV) due
to a respiratory virus infection.

4. Presence of Influenza A (Flu A), Influenza B (Flu B), respiratory syncytial virus
(RSV), rhinovirus (RV), adenovirus, parainfluenza, human metapneumovirus (HMPV), or
coronaviruses (including SARS-COV-2 and seasonal coronaviruses) in a nose swab
sample, confirmed by a positive virus test using a Sponsor approved rapid POC test
(e.g., reverse transcription polymerase chain reaction [RT-PCR]).

5. Time from intubation to administration of first dose of study medication ≤48 hours.

6. Women of childbearing potential must have a negative pregnancy test. For this study,
women of childbearing potential are defined as women <55 years old.

Part 1 Exclusion Criteria:

A participant must not be randomised into Part 1 of the study if they meet any of the
following criteria:

1. Expected termination of IMV within 24 hours from the time of randomisation

2. Life expectancy <24 hours.

3. Liver failure (Child-Pugh C).

4. Severe congestive heart failure (New York Heart Association [NYHA] IV).

5. Receipt of lung transplant.

6. Known or suspected active tuberculosis, or infection with other mycobacteria

7. Known or suspected active systemic fungal infection.

8. Anticipated transfer to another hospital which would prevent the participant from
continuing in the study and completing protocol assessments.

9. Need for long-term mechanical ventilation prior to ICU admission.

10. Use of inhaled sedation.

11. Presence of tracheostomy or laryngectomy.

12. Requirement for airway pressure release ventilation mode.

13. History of hypersensitivity to natural or recombinant IFNβ or to any of the
excipients in the drug preparation.

14. Any condition, including findings in the patient's medical history or in the
pre-randomisation study assessments that in the opinion of the Investigator,
constitute a risk or a contraindication for participation in the study or that could
interfere with the study objectives, conduct, or evaluation.

15. Participation in previous clinical studies of SNG001.

16. Current or previous participation in another clinical study where the participant
has received a dose of an Investigational Medicinal Product (IMP) containing small
molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into
this study or containing biologicals within 3 months prior to entry into this study.

17. Known or suspected pregnancy.

18. Females who are breast-feeding or lactating.

19. Immunocompromising condition, including:

- Established acquired immune deficiency syndrome (AIDS) defined as a cluster of
differentiation 4 (CD4) count <200 cells/microL, and/or the presence of any
AIDS-defining condition;

- Haematological malignancy;

- Bone marrow transplantation; or

- Immunosuppressive therapy, including:

- Cancer therapy (e.g. chemo-, radio-, immuno-, hormone or other types of
therapy), immune-cell depleting therapy, immunosuppressive therapy for
autoimmune disorders, medications for prevention of organ transplantation
rejection, administered within 6 months prior to randomisation; or

- Corticosteroids >20 mg of prednisone or equivalent per day administered
continuously for >14 days prior to randomisation.

20. Severe chronic lung disease requiring home oxygen therapy, including chronic
obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis.

Part 2 Inclusion Criteria:

To be eligible for randomisation into Part 2 of this study, each participant must fulfil
the following criteria:

1.a Patients ≥18 and <50 years of age at the time of consent, with an immunocompromising
condition, including:

- Solid tumour malignancy undergoing cancer therapy (e.g. chemo-, radio-, immuno-,
hormone or other types of therapy);

- Haematological malignancy in remission, with or without maintenance therapy;

- Immunosuppressive therapy for autoimmune disease;

- Therapy for prevention of organ transplant rejection;

- Corticosteroids >20 mg of prednisone or equivalent per day, administered
continuously for >14 days prior to randomisation or

1. b Patients ≥50 years of age at the time of consent, with or without an
immunocompromising condition (as defined above).

2. Patient admitted to the ICU and requiring IMV due to a respiratory virus
infection.

3. Presence of Flu A, Flu B, RSV, RV, adenovirus, parainfluenza, HMPV, or
coronaviruses (including SARS-COV-2 and seasonal coronaviruses) in a Lower
Respiratory Tract sample, confirmed by a positive virus test using a Sponsor
approved rapid POC test (e.g., RT-PCR).

4. Time from intubation to administration of first dose of study medication ≤48
hours.

5. Informed consent or legal representative's consent obtained.

6. Women of childbearing potential must have a negative pregnancy test. For this
study, women of childbearing potential are defined as women <55 years old.

Part 2 Exclusion Criteria:

A participant must not be randomised into Part 2 of the study if they meet any of the
following criteria:

1. Expected termination of IMV within 24 hours from the time of randomisation.

2. Life expectancy <24 hours.

3. Liver failure (Child-Pugh C).

4. Severe congestive heart failure (NYHA IV).

5. Receipt of lung transplant.

6. Known or suspected active tuberculosis, or infection with other mycobacteria.

7. Known or suspected systemic fungal infection.

8. Immunocompromising condition, including:

- Haematological malignancy requiring induction or consolidation therapy within 3
months prior to randomisation;

- Bone marrow transplant within 6 months prior to randomisation;

- Solid organ transplant within 6 months prior to randomisation;

- Corticosteroids >75 mg of prednisone or equivalent per day, administered
continuously for >7 days prior to randomisation;

- Methotrexate therapy at randomisation, if the indication is chemotherapy for
cancer;

- Chimeric antigen receptor (CAR)-T cell therapy, administered within 3 months
prior to randomisation;

- Ibrutinib or alemtuzumab, administered within 3 months prior to randomisation;

- Neutropenia <500/mm3 not due to sepsis;

- Clinical presentation consistent with severe bone marrow suppression or
pancytopenia;pancytopenia;

- Established AIDS, defined as a CD4 count <200 cells/microL, and/or the presence
of any AIDS-defining condition.

9. Anticipated transfer to another hospital which would prevent the participant from
continuing in the study and completing protocol assessments.

10. Need for long-term mechanical ventilation prior to ICU admission.

11. Use of inhaled sedation.

12. Presence of tracheostomy or laryngectomy

13. History of hypersensitivity to natural or recombinant IFNβ or to any of the
excipients in the drug preparation.

14. Any condition, including findings in the patient's medical history or in the
pre-randomisation study assessments that in the opinion of the Investigator,
constitute a risk or a contraindication for participation in the study or that could
interfere with the study objectives, conduct, or evaluation.

15. Participation in previous clinical studies of SNG001.

16. Current or previous participation in another clinical study where the participant
has received a dose of an IMP containing small molecules within 30 days or 5
half-lives (whichever is longer) prior to entry into this study or containing
biologicals within 3 months prior to entry into this study.

17. Known or suspected pregnancy.

18. Females who are breast-feeding or lactating.

19. Severe chronic lung disease requiring home oxygen therapy, including chronic
obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Belgium
France
Netherlands
Spain
United Kingdom
United States
Locations

University of California - Davis
Sacramento, California, United States

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States

NCH Pulmonary Critical Care
Naples, Florida, United States

Emory University
Atlanta, Georgia, United States

Snake River Research, PLLC
Idaho Falls, Idaho, United States

Northwestern University
Chicago, Illinois, United States

Sinai-Grace Hospital
Detroit, Michigan, United States

William Beaumont Hospital
Royal Oak, Michigan, United States

Mayo Clinic - Rochester
Rochester, Minnesota, United States

Washington University in St. Louis
St Louis, Missouri, United States

VA Western New York Healthcare system
Buffalo, New York, United States

NYU Langone Tisch Hospital
New York, New York, United States

University of North Carolina (UNC)
Chapel Hill, North Carolina, United States

University of Cincinnati Medical Center (UCMC)
Cincinnati, Ohio, United States

The Cleveland Clinic Foundation
Cleveland, Ohio, United States

The Ohio State University (OSU)
Columbus, Ohio, United States

Mercy St. Vincent Medical Center
Toledo, Ohio, United States

Oregon Health & Science University (OHSU)
Portland, Oregon, United States

AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, United States

Baylor University Medical Center
Dallas, Texas, United States

The University of Texas Health Science Center at Houston
Houston, Texas, United States

Medical College of Wisconsin
Milwaukee, Wisconsin, United States

Universitair Ziekenhuis Brussel
Brussels, Belgium

Ziekenhuis Oost-Limburg - Campus Sint-Jan
Genk, Belgium

Centre Hospitalier Régional de la Citadelle
Liège, Belgium

Centre Hospitalier Universitaire (CHU) de Liege
Liège, Belgium

Centre Hospitalier d'Argenteuil
Argenteuil, France

Centre Hospitalier de Bourg-en-Bresse
Bourg-en-Bresse, France

CHD Vendee
La Roche-sur-Yon, France

CH Le Mans
Le Mans, France

CHU de Lille
Lille, France

CHU de Limoges - Hopital Dupuytren 1
Limoges, France

CHU de Nantes - Hotel-Dieu
Nantes, France

HCL Centre Hospitalier Lyon Sud
Pierre-Bénite, France

CHU de Rouen - Hopital Charles-Nicolle
Rouen, France

CHU St Etienne - Hopital Nord
Saint-Priest-en-Jarez, France

CHRU de Strasbourg
Strasbourg, France

CHRU de Tours - Hopital Bretonneau
Tours, France

Ziekenhuis Gelderse Vallei
Ede, Netherlands

Canisius-Wilhelmina Ziekenhuis (CWZ)
Nijmegen, Netherlands

Ikazia Ziekenhuis
Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht
Utrecht, Netherlands

Hospital Universitario Vall d'Hebron
Barcelona, Spain

Hospital Clinic Barcelona
Barcelona, Spain

Hospital Universitari Mutua Terrassa
Barcelona, Spain

Hospital Universitari de Bellvitge
Barcelona, Spain

Hospital Universitario 12 de Octubre
Madrid, Spain

Torbay Hospital
Paignton, Devon, United Kingdom

Aberdeen Royal Infirmary
Aberdeen, United Kingdom

Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom

Bradford Royal Infirmary
Bradford, United Kingdom

Royal Sussex County Hospital
Brighton, United Kingdom

Cardiff and Vale Hospital
Cardiff, United Kingdom

Glasgow Royal Infirmary
Glasgow, United Kingdom

Queen Elizabeth University Hospital
Glasgow, United Kingdom

Hull Royal Infirmary
Hull, United Kingdom

Leicester Royal Infirmary
Leicester, United Kingdom

University College London Hospital
London, United Kingdom

Royal Free Hospital
London, United Kingdom

St George's Hospital
London, United Kingdom

Manchester Royal Infirmary
Manchester, United Kingdom

The James Cook University Hospital
Middlesbrough, United Kingdom

Freeman Hospital
Newcastle upon Tyne, United Kingdom

Queens Medical Centre (QMC)
Nottingham, United Kingdom

Derriford Hospital
Plymouth, United Kingdom

Queen Alexandra Hospital
Portsmouth, United Kingdom

Southampton General Hospital
Southampton, United Kingdom

Contacts

Sophie Hemmings
+442380512800
submissions@synairgen.com

Not Provided

Synairgen Research Ltd.
NCT Number
Keywords
Influenza
Respiratory Syncytial Virus
Rhinovirus
Adenovirus
Human metapneumovirus
Coronavirus
Intubated
Mechanically ventilated
Interferon
intensive care
SARS-CoV-2
Parainfluenza
MeSH Terms
Pneumonia, Viral
Influenza, Human
Adenoviridae Infections
Coronavirus Infections
Paramyxoviridae Infections