COVID-19

Background

Coronaviruses cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The most recently discovered coronavirus (SARS-CoV-2) causes coronavirus disease COVID-19

COVID-19 is a global threat and there is an urgent need to assess new treatments to prevent and effectively treat the severe lower respiratory tract (LRT) illness that occurs in around 1 out of 6 people 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*. To date, according to the WHO, there is no vaccine and no specific antiviral medicine to prevent or treat COVID-19*.

IFN-β for the treatment of COVID-19

Interferon beta (IFN-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 lung disease during respiratory viral infections. Furthermore, viruses, including coronaviruses, have evolved mechanisms which suppress endogenous IFN-beta production, thereby helping the virus evade the innate immune system.

In the lab IFN-beta has been shown to protect cells from infection with a broad range of respiratory viruses that cause LRT illness including the pathogenic MERS-CoV and SARS-CoV coronavirus strains (Figure 1 below). IFN-beta would also be expected to protect against the COVID-19 coronavirus strain.

Synairgen is developing a formulation of IFN-beta, called SNG001, for direct delivery to the lungs via nebulisation, to treat and/or prevent LRT illness caused by respiratory viruses.

In clinical trials in asthma and COPD, inhaled SNG001 has been well tolerated and shown to upregulate lung antiviral defences. In two Phase II trials in asthma, inhaled SNG001 improved lung function in patients with a cold or flu infection. A trial in COPD is ongoing. Early data has shown that the drug is well tolerated and upregulates lung antiviral defences in COPD.

SNG001 therefore could prove to have an important role to play in outbreaks such as the current COVID-19 epidemic, particularly in at risk groups that develop severe LRT viral illness.

Figure 1. SNG001 reduced viral load following MERS-CoV infection in cell-based assays with a similar potency to that seen against other respiratory viruses

COVID-19 Clinical Trial

On the 18th March Synairgen announced that it 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.

Synairgen’s Phase II trial in COVID-19 patients, called SG016 (EudraCT: 2020-001023-14), is a double-blind, placebo-controlled trial. Initially, the pilot phase of the study involving 100 COVID-19 patients, is taking place across a number of NHS trusts. It 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. A successful outcome from the pilot phase will inform onwards progression of SNG001 in COVID-19 patients. The trial is expected to commence imminently.

Synairgen’s other current activities with COVID-19

Since the outbreak of COVID-19, Synairgen has been approached by, and is in discussion with, a number of other medical, scientific, and Governmental bodies (both in the UK, US and internationally) seeking to investigate novel therapeutics in this area.

References

  1. Sourced from WHO website 15th Mar 20