Respiratory drug discovery and development company Synairgen has received expedited approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) to conduct a trial of SNG001 in COVID-19 patients to potentially assist with the global outbreak of the virus. SNG001 is an inhaled formulation of interferon-beta-1a.
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 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 of these at-risk patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections.
In addition, 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.
SNG001 could prove to have an important role to play in outbreaks such as the current COVID-19 epidemic, particularly in respect of the population at highest risk of being severely affected by this and similar viruses.
SNG001 was identified in the WHO’s Landscape analysis of therapeutics as at 17 February 2020 as the only Phase 2/Phase 3/Observational therapy delivered by the inhaled route.
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. Trials have also shown that treatment with inhaled SNG001 reduced lung viral load and lung pathology in an in vivo swine flu driven model of viral pneumonia. At the time of the MERS-CoV outbreak in 2013, Synairgen collaborated with the National Institutes of Health (NIH) in the US to show that SNG001 could protect against MERS-CoV infection of lung cells in vitro.
Synairgen’s Phase II trial in COVID-19 patients (SG016) will be a double-blind, placebo-controlled trial. Initially, the pilot phase of the study will involve 100 COVID-19 patients, will take place across a number of NHS trusts and 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.
The trial is expected to commence imminently.
Richard Marsden, CEO of Synairgen, said: “We have worked intensively with the relevant authorities and collaborators to enable SNG001 to be assessed in COVID-19 patients.
“SNG001 has been well tolerated in clinical trials in over 200 respiratory patients to date and has accelerated lung function recovery in two Phase II asthma trials in patients with a cold or flu infection. A successful outcome from this trial in COVID-19 patients would be a major breakthrough in the fight against this coronavirus pandemic.”
Professor Tom Wilkinson, Professor of Respiratory Medicine at the University of Southampton and Trial Chief Investigator, said: “There are a limited number of candidate new treatments available and so it is vital we can rapidly generate high quality evidence on the role of these in COVID-19 patients. The UK research delivery and regulatory teams have worked incredibly effectively to enable this world leading trial to achieve approvals so rapidly, which has enabled our motivated and highly expert team of researchers to get this vital study running straight away.”