Southampton, UK-based biotech company Synairgen has been granted the go-ahead to take its lead candidate SNG001 into a trial for the treatment of COVID-19 patients.
Synairgen announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) fast-tracked an approval for the initiation of a trial evaluating its lead candidate SNG001 (inhaled formulation of interferon-beta-1a), as concerns grow in the UK that COVID-19 cases could soar in the comings weeks.
Interferon-beta (IFN-beta) is a naturally occurring protein that controls the body’s antiviral responses.
Previous evidence has found that a lack of INF-beta production in the lung could be linked to the increased susceptibility of at-risk groups who are more likely to develop severe respiratory symptoms as a result of viral infections.
Coronaviruses in particular, including the one which causes COVID-19, have evolved to suppress the body’s production of INF-beta, which aids the virus in hiding from the immune system.
The theory behind increasing the production of INF-beta during viral infection is that it could prevent or decrease symptoms of severe respiratory illness, such as pneumonia.
SNG001 delivers a formulation of INF-beta-1a to the lungs directly via nebulisation, and is suitable for inhaled delivery.
The drug has already been tested in phase 2 trials in asthma, which demonstrated an improvement in lung function in patients with a respiratory viral infection.
During the MERS-CoV outbreak back in 2013, Synairgen also collaborated with the US National Institutes of Health (NIH) to demonstrate SNG001’s efficacy against the infection of the lung cells in-vitro.
“SNG001 has been well tolerated in clinical trials in over 200 respiratory patients to date and has accelerated lung function recovery in two phase 2 asthma trials in patients with a cold or flu infection,” said Richard Marsden, CEO of Synairgen.
“A successful outcome from this trial in COVID-19 patients would be a major breakthrough in the fight against this coronavirus pandemic,” he added.
The biotech will begin a phase 2 trial in COVID-19, after an initial pilot phase of the study involving 100 patients, which is set to take place across a number of NHS trusts and has also been adopted by the NIHR Respiratory Translational Research Collaboration.
“The UK life science ecosystem is stepping up across the piece on coronavirus. It’s fantastic to see a small UK biotech company, Synairgen starting UK clinical trials immediately on COVID-19,” commented Steve Bates, CEO of the UK BioIndustry Association.
“This shows the speed at which our ecosystem can move; linking SMEs, the established UK clinical trials infrastructure of the NHS and an enabling regulator in the UK’s MHRA.
“The sector is also working flat out on innovative emergent ventilator capacity, novel vaccine scale-up capacity, new ways to support NHS patients at home with digital products and investigating antibody technology for therapeutic use,” he added.