Impact case study database

Research at the University of Southampton (UoS) over the past 30 years has led directly to the development of nebulised IFN-β as a new, successful therapy for inflammatory lung conditions such as asthma and COPD. This therapy has had tangible impacts on patient health and wealth creation, culminating in a successful clinical trial during the COVID-19 pandemic.

Formation of Synairgen (covered in REF 2014)

Synairgen was founded in June 2003 by Holgate, Davies and Djukanovic, with investment from IP2IPO Group plc (now IP Group). It was floated on the Alternative Investment Market (AIM) in October 2004, raising GBP10,500,000. [ 5.1]

In March 2004, UoS filed a patent for the use of inhaled IFN-β for treatment of virus-induced exacerbations of asthma and COPD. This allowed the pioneering research to continue through clinical trials testing IFN-β for asthma and COPD. [ 5.1]

From 2008 Synairgen concentrated its effort on the clinical development of inhaled IFN-β for the treatment of exacerbations of asthma and COPD caused by respiratory viruses. In 2009 Synairgen completed Phase I trials in moderately asthmatic subjects and progressed to Phase II proof of concept studies. Underlining significant investor confidence, the company raised GBP6,000,000 in 2009 to fund phase II clinical trials in asthma and GBP2,500,000 in 2011 to accelerate completion of asthma phase II, conduct various in vitro experiments and fund avian flu research. [ 5.1]

Synairgen’s market capitalisation was GBP26,307,751 at the end of 31 July 2013. [ 5.1]

Continued success of Synairgen and nebulised IFN-β for treatment of asthma

Since August 2013, Synairgen has increased the number of staff employed on its drug development from 15 to 19 and aided the career of staff including 9 scientists, 3 nurses and 7 trial managers, either employed directly or indirectly by the company. Its market capitalisation was GBP305,869,035 at when markets closed on 31 December 2020. [ 5.1]

Southampton’s phase II trial of nebulised IFN-β in asthma led to a global license deal between Synairgen and AstraZeneca in 2014, with an upfront payment of USD7,250,000 (06-2014) and potential development, regulatory and commercial milestones of up to USD225,000,000 as well as tiered royalties, a proportion of which goes to the University. [ 5.2]

Nebulised IFN-β for the treatment of chronic obstructive pulmonary disease (COPD)

In December 2017, Synairgen changed its strategic direction to assess IFN-β as a potential therapy for COPD. A phase II Clinical Trial of IFN-β in patients with COPD was launched in February 2018 by Wilkinson and raised GBP4,000,000. The first part of the trial was successful, showing that IFN-β boosts antiviral lung defense mechanisms in the absence of a respiratory virus. This led Synairgen to raise GBP2,900,000 in September 2018 to expand the trial from 80 to 120 patients with a confirmed respiratory viral infection. By February 2020 recruitment was almost completed when the COVID-19 outbreak started to gain momentum in the UK. [ 5.1]

Nebulised IFN-β for the treatment of COVID-19

Synairgen raised GBP5,000,000 for the University’s phase II clinical trial to test IFN-β on patients with COVID-19, which got Medicines and Healthcare products Regulatory Agency (MHRA) and ethics approval within days and was established within four weeks, an unprecedented timeframe for a trial. It involved nine other hospital sites within the UK, recruiting 101 patients, and the first part of the trial was completed within seven weeks. Following the success of the first stage, £3m was raised to expand the trial in May 2020 to include an additional 120 patients in the community setting. [ 5.1]

Results released in July 2020, showed that patients who received IFN-β had a 72% lower risk of developing severe COVID-19 compared to placebo and were more than twice as likely to recover from the disease as those on placebo. It also showed breathlessness was markedly reduced. There were no deaths among the patients who received IFN-β, demonstrating its huge “ potential as an inhaled drug to be able to restore the lung’s immune response, enhancing protection, accelerating recovery and countering the impact of SARS-CoV-2 virus.” [ 5.3]

The phase II trial and subsequent results had a substantial impact on Synairgen’s share price. Within the first 48 hours of the trial launching on 18 March 2020, Synairgen’s share price doubled from GBP0.24 to GBP0.49. Upon release of the positive results in July, the share price soared as much as 552%, taking its year-to-date gain to about 3,194%. [ 5.4].

The launch of each stage of the trial, as well as the announcement of the results, attracted worldwide media attention. Coverage in July 2020 of the first results was 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 [ 5.5].

These positive results led to Synairgen’s inhaled IFN-β being selected for the US Government funded ACTIV-2 trial (estimated value GBP100m) [ 5.6] which evaluates treating patients with mild to moderate COVID-19 symptoms not yet requiring hospitalisation. Additionally, Synairgen has commenced an in-patient global Phase III trial launched in December 2020 [ 5.7], funded through a GBP87,000,000 placement on the London Stock Exchange and led by Wilkinson. This international trial will recruit up to 610 patients and continue to evaluate IFN-β as a treatment of hospitalised COVID-19 patients, aimed at preventing the need for ventilation, and accelerating recovery.

Synairgen’s Investigational New Drug application to the US Food and Drug Administration (FDA) to evaluate IFN-β as a treatment for patients with COVID-19 was approved in December 2020, enabling Synairgen to initiate the Phase III trial in the US [ 5.7]. The FDA awarded it Fast Track status, enhancing the ability of Synairgen to interact with the FDA and shortening review timelines [ 5.8].

Rapid point of care (POC) test for viral infection

The development of the 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. Patients who received a positive POC test for COVID-19 were recruited into the trial two days earlier than patients who were tested by the lab. This successful POC testing strategy has led to further trials, which have had an impact in the clinical setting.

The ResPOC study led to an NIHR post-doctoral fellowship for Clark in 2016 to carry out a randomised control trial to assess the POC test for patients with influenza symptoms. Patients who received the POC test were given antiviral treatment on average 28 hours more quickly than those who did not have the test. Patients who had influenza diagnosed by the POC test were also isolated more appropriately and rapidly [ 5.9].

Southampton’s POC test research underpinned and was cited in Public Health England guidance, published in November 2018 and updated in October 2019, describing the benefits of implementing POC testing in hospital settings. Southampton was described as an Early Adopter (EA) site where “successful outcomes reported by EA groups include improved patient triage, better cohorting and use of isolation rooms during periods of winter pressure.” [ 5.10]

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. A clinical impact assessment trial of POC testing during the first wave of the pandemic showed that instead of taking a day to receive results, clinical staff received results in just 1.7 hours on average. Patients who received the test were transferred to the appropriate ward within eight hours, compared to 28 hours for those who did not. Additionally, patients in the emergency department who received the POC test were not transferred to an assessment area unnecessarily. This resulted in fewer bed moves, reducing the need for deep cleaning and staff exposure to COVID-19 in contaminated areas. [ 5.11]

Due to Southampton’s ground-breaking work with the POC test, Clark was asked to contribute to the Academy of Medical Sciences’ Preparing for Winter report, which gave a ‘reasonable worst case scenario’ of between 24,500 and 251,000 virus related deaths in hospital, peaking in January and February 2021. This report and the successful results of the POC test in Southampton led to Clark being seconded to the Department of Health & Social Care to assist in the national roll out of POC tests to all acute trusts. [ 5.12]