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=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

"Look at SNG001 broad spectrum anti viral drug news today #LongCovid" (@sharedycat1)

Novel Coronavirus Disease

SPRINTER: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Determine the Efficacy and Safety of Inhaled Interferon Beta-1a (SNG001) for the Treatment of Patients Hospitalised Due to COVID-19 (NCT04732949) (ERS 2022) - P3 | "If the encouraging signal in the relative risk of disease progression or death (~30% reduction) observed in this 300 patient/arm trial were confirmed in a larger trial, SNG001 could become a useful treatment option for hospitalised COVID-19 patients."

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

Synairgen announces positive findings from analysis of lung samples from the SG015 trial of SNG001 in virally infected COPD patients (Businesswire) - P2 | N=130 | NCT03570359 | Sponsor: Synairgen Research Ltd. | "Synairgen...today announces positive data from additional assessments of lung sputum samples from its Phase 2 clinical trial of inhaled SNG001 in Chronic Obstructive Pulmonary Disease (COPD) patients with a confirmed respiratory viral infection (SG015, NCT03570359)....The results suggest that HRV was cleared more rapidly in patients treated with SNG001 than placebo with a statistically significant difference in the proportion of patients with detectable HRV in sputum at Day 7 (post hoc analysis)...'Our new data from COPD patients shows that SNG001 can accelerate viral clearance from the lung and builds on our existing data supporting SNG001’s mechanism of action and our focus on severe viral lung infections. This additional assessment supports continued and further investigation of SNG001 as a possible broad-spectrum antiviral.'"

P2 data • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

SPRINTER: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Determine the Efficacy and Safety of Inhaled Interferon Beta-1a (SNG001) for the Treatment of Patients Hospitalized Due to COVID-19 (ATS 2022) - "There is no abstract associated with this presentation."

Clinical • P3 data • Infectious Disease • Novel Coronavirus Disease

SPRINTER: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Determine the Efficacy and Safety of Inhaled Interferon Beta-1a (SNG001) for the Treatment of Patients Hospitalized Due to COVID-19 (NCT04732949) (ATS 2022) - P3 | "Recruitment into the SPRINTER trial was completed in November 2021. Unblinded efficacy and safety results (expected Q1 2022) will be presented."

Clinical • Late-breaking abstract • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNB1

Synairgen Presents Detailed Analysis of Phase 3 SPRINTER Trial Evaluating SNG001 in Hospitalised COVID-19 Patients at ATS 2022 (Businesswire) - P3 | N=623 | SPRINTER (NCT04732949) | Sponsor: Synairgen Research Ltd. | "Post hoc analyses conducted in patient populations at greater risk of progression to severe disease or death suggests that SNG001 may have an important clinical effect on top of standard of care....Synairgen...today announces the first presentation of the full data analysis from its Phase 3 SPRINTER trial evaluating the efficacy and safety of SNG001 in patients hospitalised with COVID-19.... In these patients, who represented approximately one-third of the SPRINTER trial population, SNG001 significantly reduced the risk of progression to severe disease and death compared to placebo by 70% in the Per Protocol population (Odds Ratio (95% Confidence Interval) 0.23 (0.06, 0.98); p=0.046)....SNG001 was well tolerated in the SPRINTER trial with a favourable safety profile consistent with previous studies: The proportion of patients with any treatment-emergent adverse events (TEAE) related to study..."

Retrospective data • Infectious Disease • Novel Coronavirus Disease