Synairgen plc initiates Phase II trial of SNG 001 to treat COVID-19 patients .

Synairgen plc , the respiratory drug discovery and development company,announces 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 SNG 001 (inhaled formulation of interferon-beta-1a) in COVID-19 patients to potentially assist with the global outbreak of the COVID-19 virus.

Two Phase II clinical trials in asthma showed that inhaled SNG 001 treatment activated antiviral pathways in the lung along with improving lung function in patients with a respiratory viral infection. Synairgen has also shown that treatment with inhaled SNG 001 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 SNG 001 could protect against MERS-CoV infection of lung cells in vitro.

COVID-19 Clinical Trial ; 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. A successful outcome from the pilot phase will inform onwards progression of SNG001 in COVID19 patients. The trial is expected to commence imminently.

Update on SNG 001 Phase II trial in COPD: Synairgen is now close to completing a Phase II study in chronic obstructive pulmonary disease (COPD) patients with confirmed respiratory viral infections and pre-existing significant impairment of lung function. With 109 out of a target 120 participants already dosed, this trial has been paused to minimise the chance of vulnerable patients being exposed to further infection risk and to minimise distraction for respiratory staff in the UK hospitals and GP sites conducting the trial, who will be at the forefront in dealing with patients suffering from COVID-19. The company is currently exploring ways to adapt the trial to enable patients in the pre-treatment pool to to be dosed if they become infected with SARS-CoV-2.Early data from this double-blind, placebo-controlled trial have demonstrated that the antiviral responses in the lung (assessed using sputum biomarkers) are similar to those observed in the asthma trial, where we saw clinical benefit in lung function.