A trial of a new inhaled antiviral drug for COVID-19 has shown positive results and the drug is now moving into a larger international phase 3 trial of hospitalised patients, which is to be delivered with support from the NIHR.
The new treatment, a protein called interferon beta or SNG001, has been developed by the UK biotech company Synairgen and a team of scientists at the University of Southampton. The study showed that hospitalised COVID-19 patients on nebulised interferon beta recovered quicker and that the drug was safe.
Interferon beta, produced naturally by the body when it gets a viral infection, is inhaled directly into the lungs of patients with coronavirus using a nebuliser, with the aim of reducing viral load and stimulating an immune response.
Results from the phase 2 trial have been published in the Lancet Respiratory Medicine journal.
The trial has been supported by the NIHR Respiratory Translational Research Collaboration (R-TRC), led by the Oxford BRC’s Professor Ling-Pei Ho, and locally by Professors Naj Rahman and Duncan Richards. Oxford University Hospitals contributed 10% of the patients in the phase 2 trial.
The large phase 3 trial, which is expected to involve 900 participants and take place in up to 20 NHS sites, has been deemed an urgent public health research study by the Department of Health and Social Care, and will be prioritised for set-up and delivery across the NHS by the NIHR Clinical Research Network over the coming months.
Prof Ho, of the University of Oxford’s MRC Weatherall Institute of Molecular Medicine (MRC WIMM), based at the John Radcliffe Hospital, is one of the main co-authors on the paper. She said: “It was a race against time in those early days when so much was new and unclear. We needed to test the right drug, to get people together to get the clinical trial done, so we could decide on the next step.
“We anticipated that patient numbers would fall, so speed was of the essence. Oxford played a major role in the successful delivery of the trial both nationally and locally, and we are very pleased to see the publication of the paper.”
The NIHR Respiratory TRC that Prof Ho chairs pressed the case for supporting interferon beta from a scientific perspective, and the UK network of TRC leads helped the set-up of the UK multi-centre clinical trial in ultra-rapid time to catch the first wave of infections.
Professor Tom Wilkinson, Professor of Respiratory Medicine at the University of Southampton and Lead Author, 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.”
The double-blind, randomised, placebo-controlled phase 2 trial assessed the efficacy and safety of inhaled SNG001 as a therapy for patients hospitalised with COVID-19. Patients were randomised to receive SNG001 or placebo by inhalation via a mouthpiece once daily for 14 days.
SNG001 was shown to be well tolerated and patients who received the drug had greater odds of improvement and recovered more rapidly. Patients receiving SNG001 had greater odds of improvement and were more likely to recover to “no limitation of activity” during treatment There were three deaths in the placebo group and none in the SNG001 group.