Recently, UK-based Synairgen (LSE:SNG) expanded its placebo-controlled, home setting clinical trial of SNG001 (inhaled formulation of interferon-beta1a) in patients diagnosed with COVID-19. The clinical trial has now been expanded beyond the Southampton area to include patients from across the United Kingdom. Recently, a TrialSite Network member requested a breakdown of this study, the treatment, and the company. What is the promise of this study drug? How does the study set up, using technology to support a remote or decentralized model, point to a future model?
What is the Premise of the Study Drug?
This Phase 2 study was set up to investigate the use of an investigational inhaled drug called SNG001. It contains an antiviral protein called interferon beta (IFN- β). IFN- β is produced in the lungs during viral lung infections. It has been demonstrated that older people and people with some chronic diseases have an IFN- β deficiency. Many viruses inhibit IFN- β as part of their strategy to evade the immune system.
Therefore, the addition of IFN- β in vitro protects lung cells from viral infection. IFN- β protects cells against the MERS and SARS coronaviruses (close relatives of SARS-CoV-2).
SNG001 is an inhaled formulation of interferon-beta1a and presently has been under study in a Phase 2 clinical trial focusing on COPD patients. They have also conducted randomized placebo-controlled clinical trials of SNG001 involving over 200 asthma and COPD patients. The results revealed the following about SNG001:
· Well tolerated during virus infections
· Enhanced antiviral activity in the lungs (measured in sputum and blood samples)
· Offered significant lung benefit over placebo in asthma in two Phase 2 trials
What is the study hypothesis?
Synairgen believes SNG001 could help prevent worsening or accelerate the recovery of severe lower respiratory tract illness in COVID-19 patients. Patients who are in hospital or non-hospitalized high-risk groups (e.g., elderly or diabetic) are invited to participate in this clinical trial. If SNG001 proves to be beneficial, it would be a breakthrough for the treatment of COVID-19.
The study #NCT04385095 commenced March 16, 2020, and is planned to go through till the estimated primary completion date of August 31, 2020, and Estimated Study completion date of May 31, 2021. Targeting 400 participants, the primary outcome measure for the study includes from a time frame of Day 1 to day 28 the change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period—a minimum of 0 (Patient is well) to a maximum of 8 (death). Several secondary outcome measures can be viewed here.
Participating Research Sites
The following sites have been disclosed for the study:
· Belfast City Hospital
· Queen Elizabeth Hospital, Birmingham, UK
· Bradford Royal Infirmary, Bradford, UK
· Hull and East Yorkshire NHS Trust, Castle Hill Hospital, Hull, UK
· Glenfield Hospital, Leicester, UK
· Wythenshawe Hospital, Manchester, UK
· City Campus of Nottingham University, Nottingham, UK
· John Radcliffe Hospital, Oxford, UK
· University Hospital Southampton, NHS Foundation Trust
Who is the Study’s Principal Investigator?
Tom Watkinson, Professor of Respiratory Medicine and Honorary NHS Consultant Physician, University Hospital Southampton, NHS Foundation Trust
How has the Study Embraced Virtual or Decentralized Activities to Deal With COVID-19?
As it turns out, the sponsors and sites realized that based on visits to the clinical trial website for SNG001, the majority of eligible patients who completed online assessments lived too far from Synairgen’s virus testing laboratory in Southampton to enter the trial. Hence Synairgen amended the trial protocol to allow patients from elsewhere in the UK into the trial, provided they have a positive test form another laboratory, e.g., from an NHS testing facility.
Participants can now participate in this study in the home setting. The principal investigators and coordinators and/or nurse will see the patient via daily video calls. All trial supplies, such as a pulse oximeter, thermometer, nebulizer, and the trial drug, are delivered directly to the patient, thereby minimizing the chance that the patient could spread the virus.
Design Goals and Objectives
In addition to evaluating the safety and efficacy of the treatment, the study design—a home-based trial—will not only test the effectiveness of SNG001 on patients identified earlier in the disease progression, but it will also generate valuable experience in the design and practical delivery of a model of remote care for at-risk patients in this and future outbreaks.
Synairgen focuses primarily on severe asthma and COPD and uses its differentiating human biology BioBank platform and world-renowned international academic Key Opinion Leader network to discover and develop novel therapies for respiratory disease.
Leveraging its scientific and clinical facilities at Southampton General Hospital, the Company uses in vitro and ex vivo models to progress opportunities into clinical development. The BioBank of human samples is used in these models to increase confidence in the likelihood of successful drug development.