Phase 2 study of inhaled SNG001 in mechanically ventilated patients with respiratory virus infection

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Synairgen Research Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

completed 13 Mar 2026

Decision date (initial)

2025-10-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Synairgen Research Ltd

External identifiers

EU CT number

2024-520375-27-00

WHO UTN

U1111-1317-0525

ClinicalTrials.gov

NCT06999603

ISRCTN

ISRCTN30482473

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

Part 1:
To evaluate the safety of SNG001 administration to participants with a confirmed respiratory virus infection undergoing invasive mechanical ventilation (IMV).
Part 2:
⁠To evaluate the efficacy of SNG001 versus placebo in participants with a confirmed respiratory virus infection undergoing IMV.

Secondary objectives 2

1. 1. Part 2: To evaluate the safety of SNG001 administration to participants with a confirmed respiratory virus infection undergoing IMV.
2. 2. Part 2: To evaluate antiviral and biomarker responses after administration of SNG001.

Conditions and MedDRA coding

Lower respiratory tract viral infections

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. 1. Part 1: Informed consent or legal representative’s consent obtained.
2. 2. Part 1: Patients ≥50 years of age at the time of consent.
3. 3. Part 1: Patient admitted to the ICU and requiring IMV due to a respiratory virus infection
4. 4. Part 1: 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 point of care (POC) test (e.g., reverse transcription polymerase chain reaction [RT-PCR]) or SOC test via any sample type (SOC sample collected not more than 48 hours prior to intubation).
5. 5. Part 1: Time from intubation to administration of first dose of study medication ≤48 hours.
6. 6. Part 1: Women of childbearing potential must have a negative pregnancy test. For this study, women of childbearing potential are defined as women <55 years old.
7. 7. Part 2: 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 b. Patients ≥50 years of age at the time of consent, with or without an immunocompromising condition (as defined above).
8. 8. Part 2: Patient admitted to the ICU and requiring IMV due to a respiratory virus infection.
9. 9. Part 2: Presence of Flu A, Flu B, RSV, RV, adenovirus, parainfluenza, 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., RT-PCR) or SOC test via any sample type (SOC sample collected not more than 48 hours prior to intubation).
10. 10. Part 2: Time from intubation to administration of first dose of study medication ≤48 hours.
11. 11. Part 2: Informed consent or legal representative’s consent obtained.
12. 12. Part 2: Women of childbearing potential must have a negative pregnancy test. For this study, women of childbearing potential are defined as women <55 years old.

Exclusion criteria 39

1. 1. Part 1: Expected termination of IMV within 24 hours from the time of randomisation.
2. 5. Part 1: Receipt of lung transplant.
3. 6. Part 1: Known or suspected active tuberculosis, or infection with other mycobacteria.
4. 7. Part 1: Known or suspected active systemic fungal infection.
5. 8. Part 1: Anticipated transfer to another hospital, which would prevent the participant from continuing in the study and completing protocol assessments.
6. 9. Part 1: Need for long-term mechanical ventilation prior to ICU admission.
7. 15. Part 1: Participation in previous clinical studies of SNG001.
8. 16. Part 1: 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.
9. 17. Part 1: Known or suspected pregnancy.
10. 18. Part 1: Females who are breast-feeding or lactating.
11. 19. Part 1: 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.
12. 10. Part 1: Use of inhaled sedation.
13. 20. Part 1: Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis.
14. 21. Part 2: Expected termination of IMV within 24 hours from the time of randomisation.
15. 22. Part 2: Life expectancy <24 hours.
16. 23. Part 2: Liver failure (Child-Pugh C).
17. 24. Part 2: Severe congestive heart failure (NYHA IV).
18. 25. Part 2: Receipt of lung transplant.
19. 26. Part 2: Known or suspected active tuberculosis, or infection with other mycobacteria.
20. 27. Part 2: Known or suspected active systemic fungal infection.
21. 28. Part 2: 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; • Established AIDS, defined as a CD4 count <200 cells/microL, and/or the presence of any AIDS-defining condition.
22. 29. Part 2: Anticipated transfer to another hospital, which would prevent the participant from continuing in the study and completing protocol assessments.
23. 11. Part 1: Presence of tracheostomy or laryngectomy.
24. 30. Part 2: Need for long-term mechanical ventilation prior to ICU admission.
25. 12. Part 1: Requirement for airway pressure release ventilation mode.
26. 13. Part 1: History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation.
27. 14. Part 1: 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.
28. 2. Part 1: Life expectancy <24 hours.
29. 3. Part 1: Liver failure (Child-Pugh C).
30. 4. Part 1: Severe congestive heart failure (New York Heart Association [NYHA] IV)
31. 31. Part 2: Use of inhaled sedation.
32. 32. Part 2: Presence of tracheostomy or laryngectomy.
33. 33. Part 2: History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation.
34. 34. Part 2: 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.
35. 35. Part 2: Participation in previous clinical studies of SNG001.
36. 36. Part 2: 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.
37. 37. Part 2: Known or suspected pregnancy.
38. 38. Part 2: Females who are breast-feeding or lactating.
39. 39. Part 2: Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part 1: The occurrence and severity of adverse events (AEs), and serious adverse events (SAEs), including pre-specified respiratory and cardiovascular deteriorations.
2. Part 2: All-cause mortality within 28 days from randomisation.

Secondary endpoints 11

1. 1. Part 2: The occurrence and severity of AEs and SAEs, including pre-specified respiratory and cardiovascular deteriorations.
2. 2. Part 2: Change from baseline in modified Sequential Organ Failure Assessment (mSOFA) score during ICU stay.
3. 3. Part 2: Time to extubation.
4. 4. Part 2: Ventilator-free days over 28 days from randomisation.
5. 5. Part 2: Duration of ICU stay.
6. 6. Part 2: Duration of hospital stay.
7. 7. Part 2: All-cause mortality within 28 days post final dose.
8. 8. Part 2: Alive and free of organ support at 28 days from randomisation and at 28 days post final dose.
9. 9. Part 2: Change in Ordinal Scale for Clinical Improvement (OSCI) score from baseline to 7, 10, 14, and 28 days post randomisation.
10. 10. Part 2: Time to first negative virus test in tracheal aspirates.
11. 11. Part 2: Change from baseline in levels of IFNβ dependent biomarkers in tracheal aspirates.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Synairgen Research Limited

Sponsor organisation

Synairgen Research Limited

Address

Mailpoint 810 Level F, South Block, Tremona Road South Block Tremona Road

City

Southampton

Postcode

SO16 6YD

Country

United Kingdom

Scientific contact point

Organisation

Synairgen Research Limited

Contact name

Sophie Hemmings

Public contact point

Organisation

Synairgen Research Limited

Contact name

Sophie Hemmings

Third parties 4

Locations

4 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 32 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications