The Race To Create COVID-19 Treatment
Synairgen #SNG is a respiratory drug discovery and development company founded by University of Southampton Professors Stephen Holgate, Donna Davies and Ratko Djukanovic.
The company, focused primarily on lung viral defence in asthma and Chronic obstructive pulmonary disease (COPD), uses its differentiating human biology BioBank platform and world-renowned international academic KOL network to discover and develop novel therapies for respiratory disease.
The COVID-19 Virus
The Corona virus (COVID-19) uses its spiky surface proteins receptors on healthy cells, and then enters them, especially those in the lungs.
The viral proteins gets into cells through ACE2 receptors. Once inside, the virus hijacks healthy cells and takes command, killing the healthy cells in the process.
Figure 1: Corona Virus inside The Lungs
Image by Jürgen Jester from Pixabay
Infection and Symptoms
Once inside the cells the lungs become inflamed making it hard to breathe. This can lead to pneumonia, an infection of the tiny air sacs, called alveoli (see Figure 2), inside the lungs where the blood exchanges oxygen and carbon dioxide.
Figure 2: Human Respiratory System - Alveoli Sacks
The Corona viruses, have evolved mechanisms which suppress the body interferon-beta (IFN-β) a protein (see figure 3), with antiviral, antibacterial, and anticancer properties, thereby helping the virus evade the immune system.
Deficiency in IFN-β production by the lungs is the likely cause of the increased susceptibility of those at-risk patient groups to developing severe breathing problems and disease during respiratory viral infections.
Figure 3: Interferon-Beta (IFN-β)
Synairgen's SNG001
Synairgen is developing a formulation of IFN-β, called SNG001, for direct delivery to the lungs via nebulisation, a medical device that creates an aerosol mist from a liquid medication, suitable for inhalation, to treat and/or prevent lung respiratory tract infection caused by respiratory viruses.
SNG001 delivers extra IFN-β directly to the lungs, correcting the deficiency and counteracting viral strategies to evade the immune defences by inhibiting natural IFN-β production.
SNG001 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.
SNG001 Selection in The COVID-19 Clinical Trials
On March 18th, 2020 the company announced it had received expedited approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) to conduct a trial of its SNG001 (inhaled formulation of interferon-beta-1a) in COVID-19 patients to potentially assist with the global outbreak of the virus.
SNG001 was identified in the WHO's Landscape analysis of therapeutics as of 17 February 2020 as the only Phase 2/Phase 3/Observational therapy delivered by the inhaled route - [Ref 1].
The National Institute for Health Research (NIHR) has also identified 31 studies which are considered priority by the government including Synairgen.
Since the outbreak of COVID-19, Synairgen has been approached by, and is in discussion with,a number of other medical, scientific,and Governmental bodies (both in the UK, US and internationally) seeking to investigate novel therapeutics in this area.
Why Synairgen's SNG001 Treatment?
Synairgen has conducted randomised placebo controlled clinical trials of SNG001 involving >200 asthma and COPD patients. These trials have shown that SNG001 has:
• Been well tolerated during virus infections
• Enhanced antiviral activity in the lungs (measured in sputum and blood samples)
• Provided significant lung function benefit over placebo in asthma in two Phase II trials.
It is believed that SNG001 could help prevent worsening or accelerate recovery of severe Lower Respiratory Tract (LRT) illness in COVID-19 patients Ref [2].
How Does Synairgen's SNG001 Treatment Work?
Synairgen's lab studies have shown that IFN-β protect cells from infection with a broad range of respiratory viruses that cause LRT illness including highly pathogenic coronavirus strains.
In two Phase II trials in asthma, inhaled SNG001 improved lung function in patients with a cold or flu infection. Early data has shown that the drug is well tolerated and upregulates lung antiviral defences in COPD.
SNG001 could prove to have an important role to play in outbreaks such as the current COVID-19 epidemic, particularly in at risk groups that develop severe LRT viral illness Ref [3].
Figure 4: Corona Virus Inside The Lungs
Why Does Synairgen's SNG001 Treatment Work?
The addition of exogenous IFN-β before or during viral infection of lung cells either prevents or greatly diminishes cell damage and viral replication, respectively.
Previous trials have shown that treatment with inhaled SNG001 reduced lung viral load and lung pathology in an in vivo swine flu driven model of viral pneumonia.
At the time of the MERS-CoV outbreak in 2013, Synairgen collaborated with the National Institutes of Health (NIH) in the US to show that SNG001 could protect against MERS-CoV infection of lung cells in vitro.
The SNG001 COVID-19 Clinical Trials.
The trial, led by Professor Tom Wilkinson a consultant in respiratory medicine at University Hospital Southampton and Professor of Respiratory Medicine at the University of Southampton, will initially involve 100 patients at Southampton and up to ten other NHS hospitals taking part.
Those patients will receive the best current COVID-19 care, whilst inhaling either a placebo or SNG001 for 14 days.
Richard Marsden CEO of Synairgen commented: “We have worked intensively with the relevant authorities and collaborators to enable SNG001 to be assessed in COVID-19 patients. A successful outcome from this trial in COVID-19 patients would be a major breakthrough in the fight against this coronavirus pandemic,”
In the case of positive initial results, it could see the trial expanded to more hospitals, with Synairgen increasing production of the drug in parallel.
Hospital Treatment Trials
Trials will take place at the University Hospital Southampton and will involve up to 10 other NHS hospitals.
Although results are not expected to be published until June 2020, a recent article released by Melton Times on April 22, 2020, a 62 year old man, who was admitted to Glenfield Hospital in Leicester, reported he feels lucky to be alive after recovering from coronavirus.
Kevin Bunney reported that when his condition stabilised he was approached by two nurses who asked if he would be keen to take part in a medicine trial, which involves 100 people in the UK who have had both Covid-19 and pneumonia - Ref [4].
Kevin commented “It is very humbling to be asked to take part in these tests and I am continuing to do it while I am back at home. They have given me a nebuliser and I have to do tests every 24 hours as part of the research"
Chris Brightling, professor of respiratory medicine at the University Hospitals of Leicester NHS Trust, said the research Kevin and fellow Covid-19 survivors were taking part in was vitally important.
According to the University Hospitals of Leicester NHS Trust website, patients presenting with COVID-19 at their hospitals will be asked to take part in a clinical trials. It is important to note from the list of clinical trials the hospital is conducting, SNG001 is the only nebuliser - Ref [5].
Although it is not clear if Kevin was given the actual treatment or a placebo, it is good to see that his condition stabilised, and that patients are willing to take part in this trial.
Home Treatment Trials
On April 30th, 2020 Synairgen received approval to extend SG016 clinical study of SNG001 in COVID-19 to initiate patients in the home environment Ref [6].
The SG016 study protocol currently allows patients to take daily doses of the study medication (SNG001 or placebo) at home or in hospital. Hospitalised patients in SG016 who have subsequently been discharged home during the 14-day treatment period, have been successfully taking the study medication at home Ref [2].
Funding and Recent Seller.
On March 26th, 2020 Synairgen announced a heavily oversubscribed fundraising of £14.0 million at a price of 35 pence per share. Some of the company directors have conditionally subscribed for an aggregate of 214,285 shares.
Lansdowne Partners Ltd a substantial shareholder in the Company holding 10% at the time, agreed to subscribe for 4,285,714 Placing Shares, representing 10.7% of the total New Ordinary Shares. However over recent weeks Lansdowne have been reducing their position in Synairgen.
Conclusion:
1-SNG001 delivers extra IFN-β directly to the lungs,
2-SNG001 corrects the deficiency and counteracting viral strategies to evade the immune defences by inhibiting natural IFN-β production
3-SNG001 was identified in the WHO's Landscape analysis of therapeutics
4-Synairgen received expedited approvals from the MHRA and HRA to conduct a trial of its SNG001
5-Synairgen is in discussion with,a number of other medical, scientific,and Governmental bodies (both in the UK, US and internationally)
6-Inhaled SNG001 has been well tolerated and shown to upregulate lung antiviral defences in clinical trials in asthma and COPD
7-Synairgen received approval to extend SG016 clinical study of SNG001 in COVID-19 to initiate patients in the home environment
8-Results are expected to be published in June 2020
9-Positive initial results could see the trial expanded to more hospitals, with Synairgen increasing production of the drug in parallel.
References:
Ref 1 - https://www.who.int/blueprint/priority-diseases/key-action/Table_of_therapeutics_Appendix_17022020.pdf?ua=1
Ref 2 - https://www.hra.nhs.uk/covid-19-research/approved-covid-19-research/281317/
Ref 3 - https://www.synairgen.com/covid-19/
Ref 4 - https://www.meltontimes.co.uk/news/people/melton-man-describes-his-battle-evil-coronavirus-2546753
Ref 5- https://www.leicestersresearch.nhs.uk/about-us-2/covid-19-and-clinical-research/covid-19-trials/
Ref 6- https://www.nihr.ac.uk/covid-studies/study-detail.htm?entryId=281317
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The writer (@Belcourtoi) currently own shares in SNG.
