Synairgen plc - Home trial recruitment completed
('Synairgen' or the 'Company')
Synairgen announces completion of recruitment into its Phase II Home-Based COVID-19 study of inhaled interferon beta
- Establishing proof of concept for home administration
The COVID-19 Phase II Study (SG016)
Synairgen's two-part, placebo-controlled trial evaluating SNG001 as a treatment for COVID-19 infection involved dosing of (i) 101 patients in the hospital setting, the positive results from which were published in The Lancet Respiratory Medicine in
Innovative Virtual Trial Design for Home-Based Study
The study targeted patients with a positive SARS-CoV-2 test result aged over 65, and those over the age of 50 with 'high risk' medical conditions. The trial was designed to make it easy and safe for trial participants and researchers to conduct the study; all -supplies were delivered directly to the patient's door by a courier, and all trial assessments were conducted remotely by study doctors and nurses via video call. The study has confirmed the feasibility of rapid roll-out of antiviral treatment in the context of a pandemic, where there is a need to limit the movement of people to minimise risks to patients, the public and healthcare providers.
The trial was conducted in collaboration with the NIHR Southampton Clinical Trials Unit and TranScrip Partners.
In addition to The Lancet Respiratory Medicine publication, there is a growing body of evidence to support use of interferon beta in the context of COVID-19 infection as evidenced in the recent publication in Nature Genetics, following research carried out by the University of Southampton and published here.
1. The Lancet Respiratory Medicine: "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". Monk, P D PhD, et al.,
2. Nature Genetics: "A novel ACE2 isoform is expressed in human respiratory epithelia and is upregulated in response to interferons and RNA respiratory virus infection".
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Notes for Editors
Synairgen is a clinical-stage respiratory drug discovery and development company founded by University of Southampton Professors Sir Stephen Holgate,
Synairgen's differentiating human biology BioBank platform and world-renowned international academic KOL network has broader applicability for lung viral defence in other respiratory disorders including asthma and COPD. Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com
SNG001 (inhaled Interferon beta) applicability to COVID-19
Interferon beta ('IFN-beta') is a naturally-occurring protein, which orchestrates the body's antiviral responses. It is used widely in the treatment of multiple sclerosis and is a safe and well tolerated drug. There is growing evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility in 'at-risk' patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections. Furthermore, viruses, including coronaviruses such as SARS-CoV-2, have evolved mechanisms which suppress endogenous IFN-beta production, helping the virus to evade the innate immune system. The addition of exogenous IFN-beta before or during viral infection of lung cells in vitro either prevents or greatly reduces viral replication, potentially reducing the severity of infection and accelerating recovery. Synairgen's SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulisation. It is pH neutral, and is free of mannitol, arginine and human serum albumin, making it suitable for inhaled delivery direct to the site of action. Phase I and II trial data have shown that SNG001 activates lung antiviral defences as measured in sputum cells, and that SNG001 has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date.
The results were published in The Lancet Respiratory Medicine: "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". Monk, P D PhD, et al.,
About Southampton Clinical Trials Unit
The Southampton Clinical Trials Unit (CTU) is a National Institute for Health Research (NIHR) supported CTU with expertise in the design, conduct and analysis of interventional clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. (www.southampton.ac.uk/ctu/index.page)
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