SNG001 in COVID-19: Trial Imminent on Respiratory Infection Response

Following expedited approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA), respiratory drug discovery and development company Synairgen is to conduct a trial of SNG001 (inhaled formulation of interferon-beta-1a) in COVID-19 patients.

Caused by the SARS-CoV-2 virus, COVID-19 can cause severe lower respiratory tract illness particularly in the elderly and those with co-morbidities such as heart and lung complications, or diabetes.

Interferon beta is a naturally occurring protein, which orchestrates the body’s antiviral responses and deficiency in IFN-beta production by the lung could explain the enhanced susceptibility of these at-risk patient groups. 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.

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.

COVID-19 Clinical Trial Synairgen’s Phase II trial in COVID-19 patients (SG016), expected to commence imminently, will be a double-blind, placebo-controlled trial, with the pilot phase study involving 100 COVID-19 patients, 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.

The company 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. Richard Marsden, CEO of Synairgen, commented: “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, commented: “We are facing an unprecedented health challenge with COVID-19 which desperately requires the rapid development of new therapeutic strategies. 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.”

Professor Stephen Holgate, Medical Research Council (MRC) Professor of Immunopharmacology, commented: “The reduced innate immune response that exists in the lung of those at most risk of serious COVID-19 disease such as older people and those with pre-existing lung disease makes such patients ideal candidates to receive inhaled SNG001 to replace their interferon deficiency. This is especially so because SARS-CoV-2, along with MERS-CoV and SARS-CoV, is equipped to evade this first line of viral defence. In the absence of a suitable vaccine, increasing the host’s own immunity to enhance protection and virus elimination would seem a logical therapeutic approach.”

For more detailed information visit www.synairgen.com