Inhaled interferon beta An official website of the United States government. Abstract. Background and Objectives Interferons have been identified as a potential treatment alternative for coronavirus disease 2019. [5] It is produced by mammalian cells, while interferon beta-1b is produced in modified E. Crit. SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA). Southampton, UK Clinical Development of Inhaled Interferon Beta-1a (SNG001) for the Treatment of Patients With COVID-19 in the Home and Hospital Settings (abstract). 145–154) report the results of a phase 2 clinical trial examining the efficacy of inhaled interferon (IFN)-β (SNG-001) for the prevention and treatment of asthma symptoms associated with upper respiratory virus infections in Press release. We assessed if it can be given safely by inhalation. Synairgen plc (‘Synairgen’ or the ‘Company’) Synairgen announces inclusion of its inhaled interferon beta treatment in US NIH ACTIV-2 trial in COVID-19 outpatients IFNAR, IFN-β tr igger s a tr anscrip tional response giving rise to the induct ion of hundreds of ISG. 8x106 IU) based on IFN-β is a key component of the innate immune response to viral infection. SNG001 contains interferon beta-1a, which is produced in mammalian cells, shares the same amino acid sequence as naturally occurring interferon-β, and has a higher specific activity than interferon beta-1b, which is produced in non-mammalian cells. We assessed the efficacy and safety of inhaled nebulised interferon beta-1a (SNG001) for the treatment of patients admitted to hospital with COVID-19. The authors found that patients who received nebulised interferon beta-1a had significantly greater odds of clinical improvement Interferon beta has shown an antiviral effect against coronaviruses, including severe acute respiratory syndrome coronavirus Tear VJ, et al. Conclusions: Although the trial did not meet its primary endpoint, it suggests that inhaled IFN-β is a potential treatment for virus-induced deteriorations of asthma in difficult-to-treat people Thursday, 12 June 2014. Immunotherapy in lung disease. After inhalation IFN-beta was not detectable in any of the serum samples as measured On-Demand Inhaled Interferon-Beta 1a for the Prevention of Severa Asthma Exacerbations: Results of the INEXAS Phase 2a Study Abstract Send to Citation Mgr. SNG001 is an IFN-β-1a nebulizer solution administered directly into the lungs to boost IFN-β levels at the site of infection. However, it is often ‘silenced’ by viruses including SARS A phase 2 randomized, double-blind, placebo-controlled trial of inhaled nebulized interferon beta-1a (SNG001) for patients hospitalized with COVID-19 (n=101) found that Safety, clinical and antiviral efficacy of inhaled interferon-β1a (SNG001) were evaluated in a phase II randomized controlled trial on the ACTIV-2/A5401 platform ( Interferon β pathway is impaired in SARS-COV2 infection and this is associated with a bigger disease burden. Rationale: Ex vivo, bronchial epithelial cells from people with asthma are more susceptible to rhinovirus infection caused by deficient induction of the antiviral protein, IFN-β. 1. In a subset of patients in the trial with severe asthma significant improvements in Asthma Control Questionnaire scores were noted. generate a primary IFN response in the lungs because of genetic, comorbid and/or autoantibody host responses. The present invention provides interferon-beta (IFN-β) for use in the treatment of virus-induced COPD exacerbations in patients treated with systemic corticosteroids, wherein IFN-β is administered by inhalation, e. 23 SNG001 is formulated at pH 6·5 (as low pH is known to cause cough) and does not contain A recent study has shown that SARS-CoV-2 was sensitive to type I inhaled interferon pretreatment in vero cells (Lokugamage et al. AstraZeneca today announced a global licence agreement with Synairgen Plc, an AIM-listed UK company specialising in respiratory diseases, for SNG001, a novel, inhaled interferon beta (IFN-beta) in clinical development for treating respiratory tract viral infections in patients with severe Conclusions No differences in clinical outcomes were found between favipiravir plus inhaled interferon beta-1b and hydroxychloroquine in adults hospitalized with moderate to severe COVID-19 pneumonia. IFN-β levels among healthy controls and COVID-19 patients. Abstract 6165. Exogenous IFN-β restores antiviral activity. The use of systemic steroids is an important consideration in the context of interferon beta treatment because corticosteroids directly affect IFN signalling, not only by reducing transcription of key factors including STAT1 and IRF9, 9 but also by their direct effects on the IFNβ receptor. Mortality was assessed at day 30 after admission. . 2014 Jul 15;190(2):145-54. First, deficient interferon responses were found in some subjects with asthma but not others (24,25). 2021; 102:538–543. In D12. Synairgen, a company based in Southampton, UK, has announced positive results from a clinical trial of SNG001 in hospitalised COVID-19 patients. Methods A double-blind, randomized, phase I clinical trial was conducted with two cohorts of However, there were still positive responses to the inhaled IFN-beta treatment in enhancing innate immunity and reducing the need for additional medications to control asthma. Rona Beegan's 10 research works with 372 citations and 587 reads, including: Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a In the INEXAS (A Study in Asthma Patients to Evaluate Efficacy, Safety and Tolerability of 14 Days Once Daily Inhaled Interferon Beta-1a After the Onset of Symptoms of an Upper Respiratory Tract Infection) phase 2 trial, 121 subjects with Global Initiative for Asthma step 4–5 asthma, with ≥2 cold-related severe exacerbations in the last 2 IFN-β is a key component of the innate immune response to viral infection. Day 15/16 odds ratio STH also has patents for the use of interferon-beta as a form of antiviral therapy for respiratory diseases (WO2005087253A3 WIPO [PCT]; issued), antiviral therapy for respiratory diseases (US20090257980A1; issued), and inhaled interferon beta for COVID-19 (pending); STH is also Chair of the Academy of Medical Sciences for the report Preparing for a challenging winter tolerability of inhaled IFN-β in moderately severe asthmatics treated with inhaled corticosteroids. Southampton, UK – 20 October 2021: Synairgen plc (LSE: SNG), the respiratory company developing SNG001, a formulation for inhalation containing the broad-spectrum anti-viral Upregulation of Antiviral Biomarkers in Sputum Cells Following Administration of Inhaled Interferon Beta to Patients with COPD P. Interferon beta is a naturally occurring protein that coordinates the body’s immune response to viral infections. Candidate: SNG001 Type: Inhaled formulation of interferon beta-1a Status: Synairgen said July 20 that SNG001 generated positive results in the Phase II SG016 trial (NCT04385095), which assessed Definitions. Eur Respir J. In addition, in BLM dose-response or TGF-β-induced lung fibroblast proliferation assays, these effects could be reversed by both parenteral and inhaled IFN-β nebulized with the mesh nebulizer. Exogenous interferons (IFN) represent a promising therapy for COVID-19 given their role in initiating the antiviral response in the respiratory tract and in vitro activity against SARS, MERS-CoV, and SARS-CoV-2. Interferon Beta-1A chemical information summary. Inhalation of SNG001 (IFN-β-1a nebuliser solution) aims to restore lung IFN-β levels. In this issue of the Journal, Djukanovic and colleagues (pp. Author Interferon-beta / therapeutic use* The present invention provides interferon-beta (IFN-β) for use in the treatment of virus- induced COPD exacerbations in patients treated with a systemic corticosteroid, wherein the IFN-β is administered by inhalation, e. In addition, several studies have reported that insufficient type I IFN responses may play a role in progression to severe COVID Inhaled beta interferon has previously shown prompt antiviral effect and protection of airways function in asthmatics with respiratory viral illness without impact on symptom severity due, potentially, to side effects from the treatment, some of which might have confounded the symptom scores used in this trial (ref: Am J Respir Crit Care Med. 48x106 IU) and increasing the doses (0. coli. Safety . 201406-1131ED. IFN-β-mediated anti-viral responses have been shown to be compromised in people susceptible to COVID-19, such as older people or patients with chronic airway diseases. Picked For You Adbry Autoinjector Approved for Moderate to Severe Atopic Dermatitis= Synairgen is a University spin-off and public limited company (plc) [2] [1] [3] working in drug discovery and biotechnology. the present invention relates to use of inhaled interferon-beta (IFN-b), e. Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled phase 2 trial. Objectives: The dynamics of exogenous IFN-β activity were investigated to inform on future clinical indications for this potential antiviral therapy. Safety and efficacy o f inhaled nebulised interferon beta-1a (SNG001) for treatment of SA RS -CoV-2 infection : a randomised, double-blind, placebo-controlled, phase 2 trial. Hence it provides new opportunities for more effective control of the pathogenesis of allergic inflammation in the lung. In a recent Semantic Scholar extracted view of "Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial" by P. It is suggested that such treatments be targeted to promote healing based on Request PDF | On May 1, 2023, P. Search for articles by The initial results, announced in a brief news release but not yet peer reviewed or published, were promising: The inhaled form of interferon beta tested by Synairgen was shown to reduce the odds SNG001 (inhaled Interferon beta) applicability to COVID-19 Interferon beta ('IFN-beta') is a naturally-occurring protein, which orchestrates the body's antiviral responses. 145258-61-3 . 2. beta for inhaled delivery by nebuliser that is in development for the treatment of virus-induced lower respiratory tract illnesses. If interferons are administered for the prevention or early treatment of viral infections, it is possible to mitigate the impact of future respiratory viral epidemics in the early stages while specific medications are Press release Synairgen plc(‘Synairgen’ or the ‘Company’) Synairgen announces inclusion of its inhaled interferon beta treatment in US NIH ACTIV-2 trial in COVID-19 outpatients ACTIV SNG001 (inhaled Interferon beta) applicability to COVID-19 Interferon beta ('IFN-beta') is a naturally-occurring protein, which orchestrates the body's antiviral responses. The effect of inhaled IFN-β on worsening of asthma symptoms caused by viral infections. 11, 12 Inhaled SNG001 has been well tolerated in clinical studies to date Interferon beta-1a (also interferon beta 1-alpha) is a cytokine in the interferon family used to treat multiple sclerosis (MS). UK-based and AIM listed, we were founded in 2003 as a spin-out from the University of Southampton. and e cacy of inhaled nebulised interferon beta-1a (SNG001) The present invention relates to use of inhaled interferon-beta for use in preventing or reducing the severity of lower respiratory tract (LRT) illness in a patient infected with a coronavirus capable of causing acute respiratory distress syndrome, e. The primary endpoint was a change in symptoms measured over two weeks, measured on a standerd scale used to categorise COVID-19. Monk et al. 3, 4 Wark et al showed impaired IFN‐β responses in rhinovirus‐infected asthmatic bronchial epithelial cells were associated with increased rhinovirus (RV) replication, which Second, a clinical trial that administered inhaled interferon-beta therapy at the first signs of a cold failed to prevent worsening of asthma symptoms . Synairgen plc (‘Synairgen’ or the ‘Company’) Synairgen announces its inhaled interferon beta (SNG001) is advancing to Phase 3 of the NIH-sponsored ACTIV-2 COVID-19 Trial . This was to evaluate the effectiveness of Favipiravir with inhaled IFN-β-1b (given in n = 44) compared to hydroxychloroquine (given in n = 45) in hospitalized COVID-19 patients with moderate to severe pneumonia. Phase IIa clinical study to commence in patients with severe asthma. The Effect of Inhaled Interferon Beta-1a (SNG001) (COPD) exacerbations. To date, studies of inhaled IFN-β treatment have not demonstrated a significant effect on asthma exacerbations. Am J Respir Crit Care Med 2023;207:A3848. To evaluate the efficacy of on-demand inhaled IFN-β1a (AZD9412) to prevent severe asthma exacerbations following symptomatic URTI. Patients (n = 112) presenting with a positive SARS-CoV-2 real-time reverse transcriptase-PCR result from their nasopharyngeal swab and pulmonary involvement were included at hospital admission. 145–154) report the results of a phase 2 clinical trial examining the efficacy of inhaled interferon (IFN)-β (SNG-001) for the prevention and treatment of asthma symptoms associated with upper respiratory virus infections in adults with asthma . SNG001 is an inhaled formulation of interferon beta. Reynolds S, Lunn K, Beegan R, Tear V, Monk PD. Inhaled IFN-β was more recently advocated as a potential anti-COVID-19 therapy based on its most potent antiviral properties among other type I IFNs and based on confirmation of the inhalation Last summer, shares of Synairgen skyrocketed 300% on a study showing its inhaled form of interferon beta-1a being developed to treat COVID-19 lessened the chance that patients would progress to a s We hypothesized that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations. A recent study has shown that SARS-CoV-2 was sensitive to type I inhaled interferon pretreatment in vero cells (Lokugamage et al. Background: The high rate of transmission and infection of coronavirus disease 2019 (COVID-19) is a public health emergency of major epidemiological concern. SARS-CoV-2 directly suppresses the release of interferon-β in vitro and patients with severe COVID-19 infection showed decreased levels of interferon activity. To date studies of inhaled IFN-β treatment have not demonstrated a significant effect on asthma exacerbations. 23 SNG001 is formulated at pH 6·5 (as low pH is known to cause cough) and does not contain Synairgen is a specialist respiratory biotechnology company whose primary focus is developing its inhaled IFN-beta candidate (SNG001) for the treatment of COVID-19 and other severe viral lung infections. Google Scholar. Third, in vivo studies in children with viral bronchiolitis or RV-induced asthma exacerbations found that type I/III interferon responses were increased in the airways and correlated with symptom expression ( 27 – 29 ). 1164/rccm. doi: 10. Nebulized IFN-β with the mesh nebulizer also significantly inhibited the migration and myofibroblast differentiation ability of TGF-β-treated HLF cells. The Company's primary focus is developing SNG001 (inhaled interferon beta) for the treatment of COVID-19 as potentially the first host-targeted, broad-spectrum antiviral treatment delivered The present invention relates to use of inhaled interferon-beta for use in preventing or reducing the severity of lower respiratory tract (LRT) illness in a patient infected with a coronavirus capable of causing acute respiratory distress syndrome, e. This was a randomized, double-blind, parallel, placebo-controlled trial of IFN-β (SNG001) (Figures 1 and 2) involving patients with a history of URTI-induced exacerbations, to test whether inhaled IFN-β can prevent or attenuate worsening asthma symptoms (defined as a rise in the six-item Juniper Asthma Control Questionnaire [ACQ-6] []) caused by respiratory viruses if The Company's primary focus is developing SNG001 (inhaled interferon beta) for the treatment of severe viral lung infections, including COVID-19, as potentially the first host-targeted, broad-spectrum antiviral treatment delivered directly into the lungs. 1 Other Identifiers. 190, 145–154. 2 Names and Identifiers. Sampling times from onset of symptoms varied Overall, the two parts of this exploratory study demonstrated proof-of-mechanism of SNG001 in patients with COPD, with upregulation of lung antiviral responses in response to inhaled interferon-β that were associated with promotion of viral clearance and a favourable safety and tolerability profile, although with limited effect on the clinical In the INEXAS (A Study in Asthma Patients to Evaluate Efficacy, Safety and Tolerability of 14 Days Once Daily Inhaled Interferon Beta-1a After the Onset of Symptoms of an Upper Respiratory Tract Infection) phase 2 trial, 121 subjects with Global Initiative for Asthma step 4–5 asthma, with ≥2 cold-related severe exacerbations in the last 2 In addition, in BLM dose-response or TGF-β-induced lung fibroblast proliferation assays, these effects could be reversed by both parenteral and inhaled IFN-β nebulized with the mesh nebulizer. Their study was extended for 6 weeks from June 22, 2020 - August 13, 2020. 16. The present invention relates to the use of inhaled interferon-beta for preventing or alleviating the severity of Lower Respiratory Tract (LRT) disease in a patient infected with a coronavirus capable of causing acute respiratory distress syndrome, for example, in a patient infected with a covd-19 of SARS-CoV-2. Eur Recently, scientists from the Universities of Oxford and Southampton have shown that inhaled IFN-β-1a is safe and effective in treating early and mild COVID-19. Am J Respir Critical Care Med. It was founded in 2003 by University of Southampton professors Stephen Holgate, [4] Donna E. 23 SNG001 is formulated at pH 6·5 (as low pH is known to cause cough) and does not contain Interferon beta (IFN-β) is key in host defence against viruses but can be suppressed by virus or host factors locally at the site of infection. Interferon beta (IFN-β) is key in host defence against viruses but can be suppressed by virus or host factors locally at the site of infection. Areas covered . Except for a slight body temperature rise and an 18% decrease in peak We hypothesized that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations. formulated for nebuliser administration via the airways, to improve outcome in SARS-CoV- IFN-β in COVID-19. In vitro, IFN-β has potent antiviral activity against SARS-CoV-2, including variants of concern. A randomized trial. The Company's primary focus is developing SNG001 (inhaled interferon beta) for the treatment of severe viral lung infections, including COVID-19, as potentially the first host-targeted, broad-spectrum antiviral treatment delivered directly into the lungs. Am. Track Citations. The present invention relates to use of inhaled interferon-beta for use in preventing or reducing the severity of lower respiratory tract (LRT) illness in a patient infected with a coronavirus capable of causing acute respiratory distress syndrome, e. SNG001 (inhaled Interferon beta) applicability to COVID-19 Interferon beta ('IFN-beta') is a naturally occurring protein, which orchestrates the body's antiviral responses. The company is developing an inhaled formulation of interferon-beta for severe viral respiratory diseases On-demand inhaled interferon-beta 1a for the prevention of severe asthma exacerbations: results of the INEXAS phase 2a study. Overall, the two parts of this exploratory study demonstrated proof-of-mechanism of SNG001 in patients with COPD, with upregulation of lung antiviral responses in response to inhaled interferon-β that were associated with promotion of viral clearance and a favourable safety and tolerability profile, although with limited effect on the clinical SNG001 contains interferon beta-1a, which is produced in mammalian cells, shares the same amino acid sequence as naturally occurring interferon-β, and has a higher specific activity than interferon beta-1b, which is produced in non-mammalian cells. , 2020) and a small pilot non-randomized study on 33 patients with moderate COVID-19 pneumonia showed that the use of inhaled interferon IFN-κ combined with trefoil factor 2 (TFF2), a secreted polypeptide resistant to Abstract. Phillip D Monk, Richard J Marsden, Victoria J Tear, Jody Brookes, Toby N Batten, Marcin Mankowski, Felicity J Gabbay, Donna E Davies, Stephen T Holgate, Ling-Pei Ho, Tristan Clark, Ratko Djukanovic, Tom M A Wilkinson, Inhaled Interferon Beta COVID-19 Study Group The effect of inhaled IFN-β on worsening of asthma symptoms caused by viral infections. Methods: Safety, clinical and antiviral efficacy of inhaled interferon-β1a (SNG001) were evaluated in a phase II randomized The protein is inhaled directly into the lungs of patients with coronavirus, using a nebuliser, Interferon beta is commonly used in the treatment of multiple sclerosis. Antiviral biomarkers are upregulated in sputum cells following administration of inhaled interferon beta to COPD patients. 2019;54:OA263. Southampton, UK The results of the University-led clinical trial of an inhaled form of interferon beta-1a (SNG001) as a treatment for COVID-19 have been published in The Lancet Respiratory Medicine journal. 48x106 IU, 2. Interferon (IFN) has been highlighted in several randomized controlled trials as an attractive therapeutic candidate based plausible mode of action, suppressed response in severe COVID-19, and inhibition of SARS UNIVERSITY OF SOUTHAMPTON, SOUTHAMPTON, UNITED KINGDOM. 1 CAS. g . Objective: To evaluate the efficacy of on-demand inhaled IFN-β1a (AZD9412) to prevent severe asthma exacerbations following symptomatic URTI. Suppression of interferon by ICS during virus-induced COPD exacerbations likely mediates pneumonia risk and raises suggestion that inhaled interferon-β therapy may protect. Breakthrough Science for Severe Viral Lung Infections. Objective: To evaluate the therapeutic effectiveness of favipiravir combined with inhaled interferon beta-1b in adult patients hospitalized with moderate to severe COVID-19 pneumonia. Here we review the comparative efficacy, safety/tolerability, and future potential of IFN-based therapeutics. J. This was a randomized, double-blind, parallel, placebo-controlled trial of IFN-β (SNG001) (Figures 1 and and2) 2) involving patients with a history of URTI-induced exacerbations, to test whether inhaled IFN-β can prevent or attenuate worsening asthma symptoms (defined as a rise in the six-item Juniper Asthma Control Questionnaire [ACQ-6] []) Methods. We aim to review the efficacy and safety of Interferon Beta (IFN-β) in patients who have a confirmed COVID-19 diagnosis. The route of delivery was selected with the aim of achieving Respiratory viral infections (RVIs) are major drivers of chronic obstructive pulmonary disease (COPD) exacerbations. Access the results of SG018 in the European Respiratory Journal Open Research (ERJOR). Synairgen's primary focus is the development of its investigational inhaled interferon beta product SNG001 to meet the significant unmet need for the treatment of severe viral lung infections in mechanically ventilated patients as the first host-directed, broad-spectrum respiratory antiviral treatment delivered directly into the lungs. We did a We assessed the efficacy and safety of inhaled nebulised interferon beta-1a (SNG001) for the treatment of patients admitted to hospital with COVID-19. 4x106 IU and 4. S, Beegan R, et al. 5x10 5 IU/kg [12,33]. 10 Therefore, corticosteroids, which were used as Human equivalent dosing in hamsters was calculated based on the dosing for subcutaneous interferon-β-1a (12x10 6 IU) and inhaled interferon-β-1a (6x10 6 IU) in clinical trials in COVID-19 patients, corresponding to an average of 1. After inhalation IFN-beta was not detectable in any of the serum samples as measured using an antiviral bioassay. Moreover, most patients with auto-Abs to type I IFNs had auto-Abs to the 13 individual IFN-α, including α2, and/or IFN-ω, but only 2% of them also had auto-Abs to IFN-β, IFN-κ, or IFN-ε []. We did a Interferon-beta (IFN-β) is a type I interferon produced at lung level which plays the sentinel role in the antiviral defense. Davies and Ratko Djukanovic [Wikidata]. P. It relates to the use of inhaled interferon-beta for use in preventing or reducing the severity of disease. 19 CXCL10 is one such ISG, whose produc t is a secrete d chem okine and thus serves as a rob Clinical trials of IFN therapeutics for COVID-19 have produced mixed results. x. 2014 Jul 15;190(2):123-4. Reynolds . The ACTIV-2 Trial Synairgen has developed SNG001, an inhaled formulation of IFN-β designed to directly target the lungs, the primary site of many viral lung infections. Int J Infect Dis. Monk . This study assessed the safety, tolerability, bioavailability, and biological activity of inhaled interferon-α2b (IFN)-α2b in healthy adults. This study suggests that inhaled exogenous IFN-λ levels in the respiratory tract can help asthmatics regulate allergic inflammation in the lungs [15]. gov NCT04518410). D. IFN-β (SNG001) nebulization treatment to lessen asthma flare Clinical Trials. The first trial (SG003) was a dose-escalating study, starting with a single low dose of IFN-β (0. Randomized controlled open label trial on the use of favipiravir combined with inhaled interferon beta-1b in hospitalized patients with moderate to severe COVID-19 pneumonia. Twenty-one healthy volunteers inhaled IFNβ-1a 300 μg, formulated for deep delivery to the lungs, in a randomized, par Background: With the emergence of SARS-CoV-2 variants resistant to monoclonal antibody therapies and limited global access to therapeutics, the evaluation of novel therapeutics to prevent progression to severe COVID-19 remains a critical need. Second, a clinical trial that administered inhaled interferon-beta therapy at the first signs The route of delivery was selected with the aim of achieving sufficiently high concentrations of interferon-β in the lungs that would result in a robust local antiviral response while limiting systemic exposure to interferon-β, which is associated with flu-like symptoms. SNG001 has been granted Fast Track designation from the US Food and Drug Administration In this issue of the Journal, Djukanovic and colleagues (pp. Randomized controlled trials of subcutaneous IFN-β in hospitalized partici-pants showed clinical benefitinsomebutnotall studies. Synairgen plc (‘Synairgen’ or the ‘Company’) Synairgen announces its inhaled interferon beta (SNG001)is advancing to Phase 3 of the NIH-sponsored ACTIV-2 COVID-19 Trial . Email to a Friend. In The Lancet Respiratory Medicine, Phillip Monk and colleagues1 report the results of a randomised, double-blind, placebo-controlled phase 2 pilot trial of nebulised interferon beta-1a in 101 adults admitted to hospital with COVID-19. Inhalation of SNG001 (IFN-β-1a Evidence before this study. This exploratory study aimed to demonstrate proof-of-mechanism, and evaluate the efficacy Methods: A total of 147 people with asthma on inhaled corticosteroids (British Thoracic Society Steps 2-5), with a history of virus-associated exacerbations, were randomized to 14-day treatment with inhaled IFN-β (n = 72) or placebo (n = 75) within 24 hours of developing cold symptoms and were assessed clinically, with relevant samples collected to assess virus produce less interferon-β, which contributes to the risk of more severe lung disease. Here is how SNG-001 (INHALED IFN-beta 1A) beta 1a, Interferon ; beta-1a, Interferon ; PubChem. Adult outpatients with confirmed SARS-CoV-2 infection within 10 days of symptom onset were randomized and initiated either orally inhaled nebulized Overall, the two parts of this exploratory study demonstrated proof-of-mechanism of SNG001 in patients with COPD, with upregulation of lung antiviral responses in response to inhaled interferon-β that were associated with promotion of viral clearance and a favourable safety and tolerability profile, although with limited effect on the clinical Eight patients with a thoracic malignancy inhaled single doses of 3-100 x 10(6) IU of human natural interferon (IFN)-beta via a dosimeter-equipped jet nebulizer. [PMC free article] [Google Scholar] Inhaled interferon: a novel treatment for virus-induced asthma? Inhaled interferon: a novel treatment for virus-induced asthma? Am J Respir Crit Care Med. Am J Respir Crit Care Med 2014; 190: 145–54 5. SAN FRANCISCO — Treatment with inhaled interferon beta failed to improve discharge and recovery in patients hospitalized with moderate COVID-19, according to results of the phase 3 SPRINTER Interferon beta 1a (IFN-β1a), designated as SNG 001, is an inhaled formulation being developed by Synairgen for the treatment of exacerbations of chronic Interferon beta 1a - Synairgen - AdisInsight Either you have JavaScript disabled or your browser does not support Javascript . Respir. , 2020) and a small pilot non-randomized study on 33 patients with moderate COVID-19 pneumonia showed that the use of inhaled interferon IFN-κ combined with trefoil factor 2 (TFF2), a secreted polypeptide resistant to degradation and SNG001 (inhaled Interferon beta) applicability to COVID-19 Interferon beta ('IFN-beta') is a naturally-occurring protein, which orchestrates the body's antiviral responses. Monk and others published Clinical Development of Inhaled Interferon Beta-1a (SNG001) for the Treatment of Patients With COVID-19 in the Home and Hospital A recent study has shown that SARS-CoV-2 was sensitive to type I inhaled interferon pretreatment in vero cells (Lokugamage et al. Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial : 101 (a) Interferon beta-1a (b) Placebo. The present invention aims to prevent or reduce the severity of lower respiratory tract (LRT) disease in patients infected with a coronavirus capable of causing acute respiratory distress syndrome, such as LRT in COVID-19 patients infected with SARS-CoV-2. Mild-severe SARS-CoV-2: Change in clinical condition on the WHO Ordinal Scale for Clinical Improvement. Methods: A randomized, open-label controlled trial of oral favipiravir in adults hospitalized with moderate to severe COVID-19 pneumonia from June 22nd 2020 to August 13th 2020 was conducted. by use of a nebuliser. Objective. , 2020) and a small pilot non-randomized study on 33 patients with moderate COVID-19 pneumonia showed that the use of inhaled interferon IFN-κ combined with trefoil factor 2 (TFF2), a secreted polypeptide resistant to Now, a team of researchers at the Synairgen Research, Southampton General Hospital, Southampton, United Kingdom, has found that inhaled nebulized interferon beta-1a (SNG001), a drug used for The lack of impact on recovery contrasts with the results from the phase II study of inhaled IFN-β in patients with COVID-19 , conducted at the beginning of the COVID-19 pandemic (March to May 2020) before any treatments that had been evaluated in randomised controlled studies were implemented as SoC. On-demand inhaled interferon-beta 1a for the prevention of severe asthma exacerbations: results of the INEXAS phase 2a study. This study identifies type I interferon as a central regulator of antibacterial immunity and mucus production. SAN FRANCISCO -- A company hoping to market an inhalable formulation of interferon beta for viral lung diseases isn't dissuaded by phase III trial results in 623 hospitalized COVID-19 patients Several studies have reported evidence of delayed or deficient type I and/or type III interferon (IFN) response to virus infection in cells from asthmatic patients compared to healthy controls. Southampton, UK – 20 October 2021: Synairgen plc (LSE: SNG), the respiratory company developing SNG001, a formulation for inhalation containing the broad-spectrum anti-viral In 2020, the COVID-19 study group on inhaled interferon beta proposed the use of nebulised interferon beta-1a as adjunctive therapy in hospitalised patients with SARS-CoV-2 infection in a phase 2 Study Design. According to the study, This was in a double-blind, placebo-controlled phase 2 study that randomised 220 adults with confirmed COVID-19 (100 hospitalised, 120 still at home) to either inhaled interferon-Beta-1a (IFN-β1a) or a matching placebo. Safety and efficacy of inhaled nebulized interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomized, double-blind, placebo-controlled, phase 2 trial; Treatment of SARS with human interferons; Impaired type I interferon In a randomized clinic trial, orally inhaled IFN-β therapy in corticosteroid-resistant asthmatic patients resulted in improved lung function, and a reduced requirement for oral corticosteroids However, there are side effects associated with IFN-β administration which may hamper the clinical application of this approach . Exogenous inhaled interferon might be beneficial in this setting. SPRINTER (NCT04732949) was a RCT of inhaled interferon beta in hospitalised COVID-19. Safety, clinical and antiviral efficacy of inhaled interferon-β1a (SNG001) were evaluated in a phase II randomized controlled trial on the ACTIV-2/A5401 platform (ClinicalTrials. 10 Therefore, corticosteroids, which were used as Interferon β pathway is impaired in SARS-COV2 infection and this is associated with a bigger disease burden. g. No definitive treatments have been established, and vaccinations have only recently begun. Phase 3 double-blind, placebo-controlled, trial of inhaled IFN-β, SNG001, in hospitalised COVID-19 patients. 2018; 201, A6165 (abstr). 25 Broadway Antiviral biomarkers are upregulated in sputum cells following administration of inhaled interferon beta to COPD patients. In the context of highly pathogenic coronaviruses, IFN-β was reportedly more active than IFN-α, at least in vitro, in its antiviral activity [141–143]. On-Demand Inhaled Interferon-Beta 1a for the Prevention of Although various therapeutic strategies, such as inhalant beta-2 agonists, corticosteroids, anti-leukotrienes, and even novel inclusion of active biological agents in the management of asthma have been established, as asthma is a global issue and chronic in nature, the search for potential new tools to the arsenal continues to this day. Methods A phase 2 randomized, double-blind, placebo-controlled trial of inhaled nebulized interferon beta-1a (SNG001) for patients hospitalized with COVID-19 (n=101) found that patients who received the study drug had greater odds of improvement on the WHO ordinal scale for clinical improvement The interferon (IFN) system is a potent line of defense against viral infections. 23 SNG001 is formulated at pH 6·5 (as low pH is known to cause cough) and does not contain excipients (such as mannitol, Khamis F, Al Naabi H, Al Lawati A, et al. Presented at: American Thoracic Society 2018 International Conference; May 18-23, 2018; San Diego, CA. Nebulized interferon-β is currently investigated as a potential therapy for SARS-COV2 because the available data from a phase II study demonstrate that this medication is able to accelerate the recovery from disease. The inhalation of interferon beta, an immune system protein molecule has a powerful broad antiviral respiratory function that can challenge or suppress Exogenous inhaled interferon might be beneficial in this setting. Keywords: Severe acute respiratory syndrome coronaviru We assessed the efficacy and safety of inhaled nebulised interferon beta-1a (SNG001) for the treatment of patients admitted to hospital with COVID-19. Provided is IFN-β, administered by use of. The type I interferons (interferon alphas and interferon beta [IFN-β]) have been tested against coronavirus infections in vitro with encouraging results. 9,10. Objectives: To compare the efficacy and safety of inhaled IFN-β with placebo administered to people with asthma after onset of cold symptoms Inhaled interferon beta-1a for COVID-19 Tom Wilkinson (University of Southampton, Southampton, UK) and colleagues performed a randomised, double-blind, phase 3 trial ( SPRINTER ) of 15·6 MIU nebulised inhaled interferon-beta 1a versus placebo in 623 patients aged at least 18 years in 17 countries hospitalised with COVID-19 who required supplemental Ho LP, Clark T, Djukanovic R, Wilkinson TMA; Inhaled Interferon Beta COVID-19 Study Group. And this was 101 patients-- half treated with placebo, half treated with inhaled interferon beta given once daily for 14 days on patients who are hospitalized with COVID-19. We reviewed human studies in which IFN or IFN pathway-interacting agents 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 SNG001 contains interferon beta-1a, which is produced in mammalian cells, shares the same amino acid sequence as naturally occurring interferon-β, and has a higher specific activity than interferon beta-1b, which is produced in non-mammalian cells. Synairgen is a specialist respiratory biotech company whose primary focus is developing our investigative inhaled interferon beta candidate (SNG001) for severe viral lung infections . Care Med. SNG001 is a formulation of recombinant interferon . We are a specialist respiratory biotech company whose primary focus is developing our investigative inhaled interferon beta (IFN-β) for the treatment of severe viral lung infections as potentially the first host-directed, broad-spectrum antiviral treatment delivered directly into the lungs. 19–22 Nebulized inhaled IFN-β (SNG001) was shown to be beneficial for hospitalized COVID-19 patients in a Phase 2 study,23 and has Interferon beta-1a (IFNβ-1a) 30 μg weekly by intramuscular (IM) injection is used to treat relapsing forms of multiple sclerosis. IFN-based agents already tested may be of use in COVID-19 or future viral respiratory outbreaks. The current study aimed to determine the safety and efficacy of inhaled nebulised interferon beta-1a in patients with SARS COV 2 infection. preventing or reducing the severity of LRT illness in COVID-19 patients infected with SARS-CoV-2. 3. Search for articles by this author, S. SNG001 has been tested in several clinical studies in both out-patient and hospital Synairgen plc (‘Synairgen’ or the ‘Company’) Synairgen announces its inhaled interferon beta (SNG001) is advancing to Phase 3 of the NIH-sponsored ACTIV-2 COVID-19 Trial . We did a randomised, double-blind, Interferon-β is naturally produced in response to viral infection, limiting replication. Monk 1. Areas covered: nebulized interferon-β is currently investigated as a potential therapy for SARS-COV2 because the available data from a phase II study demonstrate that this medication is able to accelerate SNG001 contains interferon beta-1a, which is produced in mammalian cells, shares the same amino acid sequence as naturally occurring interferon-β, and has a higher specific activity than interferon beta-1b, which is produced in non-mammalian cells. Add to Favorites. Eight patients with a thoracic malignancy inhaled single doses of 3-100 × 106 IU of human natural interferon (IFN)-beta via a dosimeter-equipped jet nebulizer. S. [6] Some research indicates that interferon injections may result in an 18–38% reduction in the rate of MS relapses. Reynolds 1. kvr vufrfq zgvl jgvkjnr zief nysoksb safe qxhbom aicjtpap hmvd