Press release by Marcin Mankowski
- Patients who received SNG001 had a 79% lower risk of developing severe disease, compared to placebo
- Patients who received SNG001 were more than twice as likely to recover from COVID-19 as those on placebo
tranScrip has provided a range of specialist support services to Synairgen for over 10 years. It has been involved in the COVID-19 programme since the beginning and is pleased to announce positive results from the clinical trial of SNG001, Synairgen’s wholly owned inhaled formulation of interferon beta (IFN-beta), in hospitalised COVID-19 patients.
SNG001, an inhaled formulation of IFN-beta, a naturally occurring antiviral and anti-inflammatory protein, has to date been investigated in virus induced exacerbations of asthma and COPD. Systemic IFN-beta is widely used for treating multiple sclerosis.
Richard Marsden, CEO of Synairgen, said: "We are all delighted with the trial results announced today, which showed that SNG001 greatly reduced the number of hospitalised COVID-19 patients who progressed from ‘requiring oxygen’ to ‘requiring ventilation’. It also showed that patients who received SNG001 were at least twice as likely to recover to the point where their everyday activities were not compromised through having been infected by SARS-CoV-2. In addition, SNG001 has significantly reduced breathlessness, one of the main symptoms of severe COVID-19. This assessment of SNG001 in COVID-19 patients could signal a major breakthrough in the treatment of hospitalised COVID-19 patients. Our efforts are now focused on working with the regulators and other key groups to progress this potential COVID-19 treatment as rapidly as possible."
The double-blind placebo-controlled trial recruited 101 patients from 9 specialist hospital sites in the UK during the period 30 March to 27 May 2020. More data is in Synairgen’s press release
Dr Flic Gabbay, Managing Partner of tranScrip, said: “We are excited to see the results, which demonstrate not only more patients improving by the study endpoint but also a clinically important reduction in the number of patients becoming worse. We are looking forward to supporting the company through the next phase of development and interactions with regulators.”
For further enquiries, please contact:
Dr Marcin Mankowski, Deputy Managing Partner
0118 963 7846
Notes for Editors
tranScrip is a specialist drug development and lifecycle management service provider based in the UK with small satellite offices in Boston, Sydney, Hong Kong and Ghana. The Business deploys multi-disciplinary project teams to deliver both strategic leadership and operational support to clients covering strategic development, medical, regulatory and commercial services. tranScrip’s approach benefits clients by maximising opportunities, reducing risk and creating value which continues to result in high quality, long-term relationships, with contracts often lasting many years. Synairgen is one of a number of tranScrip’s clients with COVID 19 programmes.
The COVID-19 study
Synairgen’s clinical trial in COVID-19 patients (SG016) is a double-blind, placebo controlled trial. The 220 patient trial comprised 100 patients initiated in hospital and 120 patients to be initiated in the home setting. The patients participating in the hospital setting , which completed recruitment in May, have been recruited across a number of NHS trusts and the trial has been adopted by the NIHR Respiratory Translational Research Collaboration which is comprised of leading centres in respiratory medicine in the UK whose internationally recognised experts are working together to accelerate development and discovery for COVID-19.
COVID-19, caused by the SARS-CoV-2 virus, is a global threat and there is an urgent need to assess new treatments to prevent and effectively treat the severe lower respiratory tract illness that can occur with this disease. Older people and those with co-morbidities such as heart and lung complications or diabetes are at greatest risk of developing severe or fatal disease.
Interferon beta (IFN-beta) potential applicability to COVID-19
Interferon beta is a naturally occurring protein, which orchestrates the body’s antiviral responses. There is 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 and MERS-CoV, have evolved mechanisms which suppress endogenous IFN-beta production, thereby helping the virus evade the innate immune system. The addition of exogenous IFN-beta before or during viral infection of lung cells either prevents or greatly diminishes cell damage and viral replication, respectively. 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.
Two Phase II clinical trials in asthma showed that inhaled SNG001 treatment activated antiviral pathways in the lung, along with improving lung function in patients with a respiratory viral infection.
Synairgen plc Press Release