Agile drug development and point of care testing for diagnosis and treatment of asthma, COPD and COVID-19
The University of Southampton has developed a successful therapy for virus-induced inflammatory lung conditions including asthma, chronic obstructive pulmonary disease (COPD) and COVID-19. The initial discovery led to the spin-out company Synairgen, whose recent advances in the treatment of COVID-19 were well publicised and led to significant patient benefit. These advances were helped by Southampton’s revolutionary point of care test, which reduces waiting time for results from one day to one hour
Overview
Research Challenge
In the early 2000s, research led by Professor Stephen Holgate found that the airway epithelium plays a pivotal role in acting as a "host" for common cold viruses
This stimulated the discovery, led by Professor Donna Davies, that bronchial epithelial cells in asthmatics could be protected against virus infection by adding interferon beta (IFN-β). This was received as a breakthrough in the search for a patient therapy.
The research led to the formation of the spin-out company, Synairgen by Professors Holgate and Davies alongside Professor Ratko Djukanovic in 2003.
Treatment of asthma
Southampton undertook phase I and phase II trials of nebulised IFN-β in asthma, which demonstrated particular benefits for severe asthmatics. This led to a global licence deal between Synairgen and AstraZeneca in 2014, including an upfront payment of $7,250,000 and potential development, regulatory and commercial milestones of up to $225,000,000.
Treatment of chronic obstructive pulmonary disease (COPD)
In 2017, Synairgen changed its strategic direction to assess IFN-β as a potential therapy for COPD. A phase II clinical trial showed that IFN-β boosts antiviral lung defence mechanisms in the absence of a respiratory virus.
This led Synairgen to raise £2.9 million in September 2018 to expand the trial from 80 to 120 patients with a confirmed respiratory viral infection. Recruitment was almost complete when COVID-19 struck the UK in February 2020.
Treatment of COVID-19
In early 2020, Synairgen raised £5 million for a phase II clinical trial at the University to test IFN-β on patients with COVID-19. The trial got regulatory and ethics approval within days and was established within four weeks – an unprecedented timeframe for a trial.
Results released in July 2020, showed that patients who received IFN-β had a 72% lower risk of developing severe COVID-19 and were more than twice as likely to recover from the disease.
The trial and results attracted worldwide media attention across broadcast, radio, print and online platforms, including outlets such as The Guardian, New York Times, The Brussels Times, CNN, BBC Radio 4 and Bloomberg.
Synairgen commenced an in-patient global Phase III trial in December 2020, funded through a £87 million placement on the London Stock Exchange and led by Professor Tom Wilkinson, of the University of Southampton.
Rapid point of care (POC) test for viral infection
The development of a POC test for respiratory infections underpinned the success of the trials for both COPD and COVID-19 by providing quicker patient diagnosis, leading to more effective recruitment.
During Synairgen’s COVID-19 trial, the POC test had positive impacts on waiting times for COVID-19 results and patient flow through Southampton General Hospital. Test results were made available within one hour – a dramatic reduction from one day.
Dr Tristan Clark, of the University of Southampton, has been seconded to the Department of Health & Social Care to assist in the national roll out of the POC test to all acute trusts.
