COVID-19 treatment results published in journal ahead of NIHR-supported phase 3 trial of nebulised interferon beta
Positive results from the early phase trial of a new inhaled antiviral drug have today been published in the Lancet Respiratory Medicine journal. This drug is now moving into a much larger phase 3 trial of patients hospitalised with COVID-19 which is being delivered across England with support from the NIHR.
Preliminary top line results from the phase 2 trial, which was supported by the NIHR Respiratory Translational Research Collaboration (R-TRC), were previously announced in July. The full research paper: "Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial” has now been published.
The respiratory drug, developed by UK biotech firm Synairgen, will now move into an international phase 3 trial which has been badged as an urgent public health research study by the Department of Health and Social Care. The trial will now be prioritised for set-up and delivery across the NHS by the NIHR Clinical Research Network over the coming months.
The phase 3 trial is expected to involve 900 participants and will take place across up to 20 NHS sites.
Professor Tom Wilkinson, Professor of Respiratory Medicine at the University, lead author, and member of the R-TRC said:
“The results confirm our belief that interferon beta, a widely known drug approved for use in its injectable form for other indications, may have the potential as an inhaled drug to restore the lung’s immune response and accelerate recovery from COVID-19. This drug provides high, local concentrations of the immune protein which boosts lung defences rather than targeting specific viral mechanisms. This might carry additional advantages of treating COVID-19 when it occurs alongside infection by another respiratory virus such as influenza or Respiratory Syncytial Virus that may well be encountered in the winter months.”
Professor Nick Lemoine, Medical Director of the NIHR Clinical Research Network said:
“Results from early phase research into Synairgen’s respiratory treatment, SNG001, show this drug’s potential as an effective therapeutic option for Covid-19. As an urgent public health study, the phase 3 trial will now be prioritised for fast track set-up and delivery across the NHS - on a much larger scale. This will give many more UK patients the opportunity to take part and potentially benefit from this exciting new treatment, as we move into the second wave.
“NIHR-supported research has already given the world the first proven treatments against this new disease. We are pleased to further support the incredible innovation emanating from the UK by delivering this large-scale trial of a Covid-19 drug developed by Synairgen - a UK biotech firm.”
Finally, Richard Marsden, Chief Executive of Synairgen said:
“So far on our journey, with NIHR support, we have been able to generate very promising phase 2 data in the hospital setting, which we aim to replicate in phase 3. We are also working to generate data in ‘at risk’ patients in the home environment, and we are also assessing the possibility of an exploratory trial in ventilated patients who persistently shed virus.
“The UK clinical research infrastructure enables us to function as we do. The cocktail of the academic world, NIHR and Clinical Research Network, the HRA, MHRA, MRC, Wellcome Trust, the investment community - the list is long - all of this creates an environment for innovative research. There is no guarantee of success but there is no chance of success unless the possible is enabled. If we are ultimately successful in developing SNG001 and making it widely available then it needs to be recognized as a successful British story.”
If you would like to hear more about the role the NIHR R-TRC has played in co-ordinating the phase 2 trial of SNG001 and other trials during the COVID-19 pandemic, please join our webinar on 30 November. Registration page and details.