Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection

Conditions

• Viral Pneumonia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SNG001 — DRUG
  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.
• Placebo — DRUG
  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).

Study Details

The goal of this Phase 2 study is to assess about the safety, antiviral biomarker responses and efficacy of SNG001 when given to patients requiring invasive mechanical ventilation due to a respiratory virus infection. Its ability to speed up virus clearance and reduce mortality, compared with standard of care, will be studied. The study is split into two parts. All participants will receive standard of care in addition to SNG001 or placebo. In Part 1, the safety of SNG001 will be assessed. Participants of 50 years and older will receive 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 18 and 50 years with an immunocompromising condition and patients over 50 years (with or without an immunocompromising condition) will receive study drug once a day for up to 14 days, whilst in hospital.

Key Dates

Start date

Sep 2, 2025

Status verified

Dec 2025

Primary completion

Apr 30, 2027

Completion

May 31, 2027

Study Design

Enrollment

550 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Safety Evaluation of SNG001
  Participants will inhale a dose of SNG001 via the Solo nebuliser, once a day for up to 14 days. A first, single syringe, low-dose cohort may be followed by an optional second cohort utilising a two-syringe dose.
• Placebo Comparator: Part 1 Safety Evaluation of SNG001 (Placebo)
  Participants will inhale a dose of placebo matched to SNG001 (only excipients of the SNG001 solution) via the Solo nebuliser, once a day for up to 14 days.
• Experimental: Part 2 Efficacy Evaluation of SNG001
  Participants will inhale the higher (two-syringe) dose of SNG001 via the Solo nebuliser, once a day for up to 14 days.
• Placebo Comparator: Part 2 Efficacy evaluation of SNG001 (Placebo)
  Participants will inhale a dose of placebo matched to SNG001 (only excipients of the SNG001 solution) via the Solo nebuliser, once a day for up to 14 days

Primary Outcome Measure

Part 1: AE and SAE Severity [ Time Frame: Up to 28 days from randomisation ]

Central Contacts

• Sophie Hemmings
  +442380512800
  [email protected]

Locations (22)

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