interferon beta inhalation (SNG001) / Synairgen - LARVOL DELTA

INVENT: Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection (clinicaltrials.gov) - P2 | N=11 | Terminated | Sponsor: Synairgen Research Ltd. | N=550 ➔ 11 | Trial completion date: May 2027 ➔ Mar 2026 | Recruiting ➔ Terminated | Trial primary completion date: Apr 2027 ➔ Mar 2026; Study was stopped due to significantly low patient recruitment rate.

Biomarker • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Pneumonia

Effect of inhaled interferon-β1a on SARS-CoV-2 diversity and evolution. (PubMed, Microbiol Spectr) - P2/3 | "SNG001, an inhaled interferon-β1a treatment, was evaluated in the ACTIV-2/A5401 randomized controlled trial of therapeutics for COVID-19...ACTIV-2/A5401 represents a unique opportunity to study the virologic effects of interferon treatment in a rigorous randomized, placebo-controlled clinical trial setting. Our characterization of longitudinal nasal samples shows that interferon-treated individuals had lower viral diversity and no evidence of viral escape mutations.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT04518410."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNB1

INVENT: Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Synairgen Research Ltd. | - | Completed ➔ Recruiting

Biomarker • Enrollment open • Trial initiation date • Infectious Disease • Pneumonia

INVENT: Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection (clinicaltrials.gov) - P2 | N=550 | Completed | Sponsor: Synairgen Research Ltd. | Not yet recruiting ➔ Completed

Biomarker • Trial completion • Infectious Disease

SG021: Phase 2 study of inhaled SNG001 in mechanically ventilated patients with respiratory virus infection (clinicaltrialsregister.eu) - P1/2 | N=134 | Not yet recruiting | Sponsor: Synairgen Research Limited

Biomarker • New P1/2 trial • Infectious Disease

INVENT: Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Synairgen Research Ltd. | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Infectious Disease • Pneumonia

INVENT: Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection (clinicaltrials.gov) - P2 | N=550 | Not yet recruiting | Sponsor: Synairgen Research Ltd.

Biomarker • New P2 trial • Infectious Disease • Pneumonia

Effect of SNG001, Inhaled IFN-β1a, on SARS-CoV-2 Diversity and Evolution (CROI 2025) - "Conclusions Treatment with inhaled SNG001 was associated with lower viral sequence diversity and less frequent emerging amino acid polymorphisms in SARS-CoV-2 isolated from nasal swabs. These results provide some of the first in vivo data on the virologic effects of exogenous interferon exposure in COVID-19 and provide intriguing evidence that interferon may prevent SARS-CoV-2 diversification and escape."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNB1

Nebulised interferon beta-1a (SNG001) in the treatment of viral exacerbations of COPD. (PubMed, Respir Res) - P2 | "Overall, SNG001 was well-tolerated in patients with COPD, and upregulated lung antiviral defences to accelerate viral clearance. These findings warrant further investigation in a larger study."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • CRP • IFNB1

Analysis of Baseline Factors Associated With Poor Clinical Outcome in a Phase 3 Trial in Patients Hospitalized Due to COVID-19 (ATS 2024) - P3 | "The SPRINTER trial was a phase 3 trial of SNG001, a formulation of IFN-β for inhalation conducted in hospitalized COVID-19 patients (Monk PD, Brookes JL, Tear VJ, et al... Baseline factors such as age, comorbidity status and BMI have been investigated and shown to affect the risk of progression to severe disease or death in patients hospitalized with COVID-19. Such factors may be applied to the inclusion criteria for future trials to select patients at greater risk of poor clinical outcomes who may benefit most from treatment."

Clinical • Clinical data • P3 data • Infectious Disease • Novel Coronavirus Disease • IFNB1

Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial. (PubMed, EClinicalMedicine) - P2/3 | "Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number UM1 AI068634, UM1 AI068636 and UM1 AI106701. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."

Journal • P2 data • Allergy • Immunology • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • IFNB1

The Effect of Inhaled Interferon Beta-1a (SNG001) Treatment Compared to Placebo on Lung Antiviral Biomarkers and Viral Clearance in Chronic Obstructive Pulmonary Disease (COPD) Patients With Respiratory Virus Infections (IDWeek 2023) - No abstract available

Biomarker • Clinical • Infectious Disease

Clinical trials of inhaled interferon beta-1a (SNG001) in COVID-19 patients in the home and hospital (ERS 2023) - "SNG001 was well tolerated across trials and should continue to be investigated for COVID-19 in the home and hospital settings.; Pulmonary function testing; Respiratory intensive care; Public health; Epidemiology; General respiratory patient care; Cell and molecular biology"

Clinical • Critical care • Infectious Disease • Novel Coronavirus Disease • IFNB1

Feasibility of home administration of nebulised interferon beta-1a (SNG001) for COVID-19: A remote study. (PubMed, BJGP Open) - P2 | "This study demonstrated that it is feasible to conduct a purely virtual study in community-based patients with COVID-19, when the study included detailed daily assessments and with medication administered via nebuliser."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNB1

ACTIV-2: A Study for Outpatients With COVID-19 (clinicaltrials.gov) - P2/3 | N=4044 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Clinical Development of Inhaled Interferon Beta-1a (SNG001) for the Treatment of Patients With COVID-19 in the Home and Hospital Settings (ATS 2023) - "SNG001 merits further investigation for treatment of COVID-19 in the home and/or hospital settings."

Clinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNB1

Clinical Trials of Inhaled Interferon Beta-1a (SNG001) in COVID-19 Patients in the Home and Hospital Settings (ISIRV-AVG 2023) - No abstract available

Clinical • Infectious Disease • Novel Coronavirus Disease

Nebulised interferon-β1a (SNG001) in hospitalised COVID-19: SPRINTER phase III study. (PubMed, ERJ Open Res) - "Serious adverse events were reported by 12.6% and 18.2% patients with SNG001 and placebo, respectively. Although the primary objective of the study was not met, SNG001 had a favourable safety profile, and the key secondary end-points analysis suggested that SNG001 may have prevented progression to severe disease."

Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNB1

"4. Presentation of SNG001 (inhaled IFN-B1A) (unvaccinated, pre-Omicron) @WFischerII No difference in main endpoints; VL and SR, but interesting trend towards reduction in hospitalisation important to tease out. https://t.co/RLBtmWwlPE" (,@drdavidwjg)

Clinical

"Yes, 7 hospitalisations on placebo vs 1 on SNG001. “Interesting trend” indeed!" (,@AdamBryson4)

Clinical

SAFETY AND EFFICACY OF INHALED INTERFERON-Β1A (SNG001) IN OUTPATIENTS WITH COVID-19 (CROI 2023) - No abstract available

Clinical • Late-breaking abstract • Infectious Disease • Novel Coronavirus Disease • IFNB1

Trial of Inhaled Anti-viral (SNG001) for SARS-CoV-2 (COVID-19) Infection (clinicaltrials.gov) - P2 | N=221 | Completed | Sponsor: Synairgen Research Ltd. | Active, not recruiting ➔ Completed | N=820 ➔ 221

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Test a Potential New Treatment for COPD Patients Suffering From the Common Cold or Influenza (clinicaltrials.gov) - P2 | N=122 | Completed | Sponsor: Synairgen Research Ltd. | Unknown status ➔ Completed

Biomarker • Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Influenza • Pulmonary Disease • Respiratory Diseases • CXCL10

"Wishing the #SNG Team well on today's high profile US discussion & bringing the unique #broadspectrum #variantagnostic benefits of #SNG001 to the wider #medical, #scientific, #Pharmaceutical & #regulatory communities. @sciam @US_FDA @bbchealth @BBCScienceNews @MHRApress @EMA_News" (,@oldscotiaprints)

Impact of Treatment of Hospitalised COVID-19 Patients With Inhaled Interferon Beta-1a (SNG001) on Long COVID Symptoms: Results From the SPRINTER trial (IDWeek 2022) - No abstract available

Clinical • Late-breaking abstract • Infectious Disease • Novel Coronavirus Disease