UK-based, publicly traded Synairgen’s stock (LSE:SNG) price exploded recently after positive clinical trial results, while the company has to issue a clarification regarding their SNG001 clinical trial due to the frenzy and zeal of the moment. The study reveals that patients given SNG001, its wholly-owned inhaled formulation of interferon beta, in hospitalized COVID-19 patients generated positive outcomes. Specifically, SNG001 greatly reduced the number of hospitalized COVID-19 patients who progressed from ‘requiring oxygen’ to ‘requiring ventilation.’ The University of Southampton spinoff falls under TrialSite’s Investor Watch.
Led by Principal investigator Tom Wilkinson of University Hospital Southampton Nhs Foundation Trust, the double-blind placebo-controlled Phase 2 trial recruited 101 patients from 9 specialist hospital sites in the UK during the period 30 March to 27 May 2020. Patient groups were evenly matched in terms of average age (56.5 years for placebo and 57.8 years for SNG001), comorbidities and average duration of COVID-19 symptoms prior to enrolment (9.8 days for placebo and 9.6 days for SNG001).
The odds of developing severe disease (e.g. requiring ventilation or resulting in death) during the treatment period (day 1 to day 16) were significantly reduced by 79% for patients receiving SNG001 compared to patients who received placebo (OR 0.21 [95% CI 0.04-0.97]; p=0.046). Patients who received SNG001 were more than twice as likely to recover (defined as ‘no limitation of activities’ or ‘no clinical or virological evidence of infection’) over the course of the treatment period compared to those receiving placebo (HR 2.19 [95% CI 1.03-4.69]; p=0.043). Over the treatment period, the measure of breathlessness was markedly reduced in patients who received SNG001 compared to those receiving placebo (p=0.007). Three subjects (6%) died after being randomized to placebo. There were no deaths among subjects treated with SNG001.
A Major Breakthrough?
Consequently, the company declared that SNG001 could be a major breakthrough in the treatment of hospitalized COVID-19 patients. The company will now focus on working with regulators and other key groups to progress this potential COVID-19 treatment as fast as possible.
The Investigational Product
Interferon beta is a naturally occurring protein, which orchestrates the body’s antiviral responses. There is evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility in ‘at-risk’ patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections. Furthermore, viruses, including coronaviruses such as SARS-CoV-2 and MERS-CoV, have evolved mechanisms which suppress endogenous IFN-beta production, thereby helping the virus evade the innate immune system. The addition of exogenous IFNbeta before or during viral infection of lung cells either prevents or greatly diminishes cell damage and viral replication, respectively. Synairgen’s SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulization. It is pH neutral, and is free of mannitol, arginine and human serum albumin, making it suitable for inhaled delivery direct to the site of action. Two Phase II clinical trials in asthma showed that inhaled SNG001 treatment activated antiviral pathways in the lung, along with improving lung function in patients with a respiratory viral infection.
The company’s stock price, trading at £35 per share last Friday, now hovers at £204, representing rapid and big appreciation. Company Chief Executive Officer Richard Marsden told Bloomberg TV, “things are moving very quickly” when asked about the approval of the drug. This is in the context of a pandemic where the British government has exhibited an openness to inject capital into promising vaccine and therapeutic approaches to taking on COVID-19.
The company issued a “clarification” today just to keep markets grounded. They emphasized that this was a Phase 2 clinical trial (perhaps some in the frenzy believed it was a pivotal Phase 3?) while additional contextual information can be found in a company website here. The company must secure regulatory approval prior to any commercialization.
The company was founded by three University of Southampton professors, including Stephen Holgate, Donna Davis and Ratko Djukanovic, back in 2004. A drug discovery and development company, they have focused their research on severe asthma and COPD, leveraging its human biology BioBank platform and world-renowned international academic Key Opinion Leader network to discover and develop novel therapies for respiratory disease.
The company leverages extensively scientific and clinical facilities at Southampton General Hospital. In 2014, it completed an out-licensing deal of SNG001 with AstraZeneca.
Their annual report can be viewed here.
Research Sites and Contacts
The following research UK sites were involved with this Phase 2 clinical trial.
|Belfast City Hospital||Lorcan McGarvey, MD FRCP||https://pure.qub.ac.uk/en/persons/lorcan-mcgarvey|
|Queen Elizabeth Hospital||Davinder Dosanjh, DPhil, MRCP, FHEA||https://www.linkedin.com/in/davinder-dosanjh-68699a48/|
|Bradford Royal Infirmary||Dinesh Saralaya, MBBS MD MRCP FRCP||https://www.spirehealthcare.com/consultant-profiles/dr-dinesh-saralaya-c4694999/|
|Hull and East Yorkshire NHS Trust, Castle Hill Hospital||Michael Crooks, MBBS||https://www.hyms.ac.uk/about/people/michael-crooks|
|Glenfield Hospital||Salman Siddiqui, Fellow||https://www.linkedin.com/in/salman-siddiqui-92465913/?originalSubdomain=uk|
|Wythenshawe Hospital||Jaclyn Smith, MB ChB MRCP PhD FRCP||https://www.research.manchester.ac.uk/portal/Jacky.Smith.html|
|City Campus of Nottingham University||Tim Harrison, MBBS FRCP MD||https://www.nottingham.ac.uk/medicine/people/tim.harrison|
|John Radcliffe Hospital||Najib Rahman, MB BCh MA||https://www.ox.ac.uk/news-and-events/find-an-expert/dr-najib-m-rahman|
|University Hospital Southampton NHS Foundation Trust||Tom Wilkinson, MBBS, PhD, FRCP||https://www.southampton.ac.uk/medicine/about/staff/tw1w07.page|
Tom Wilkinson, MBBS, PhD, FRCP, University Hospital Southampton NHS Foundation Trust