Duo of UK firms announce coronavirus therapy trials

Two UK firms have announced plans to begin trials of therapies to tackle the coronavirus outbreak.

Synairgen, based in Southampton, said it had clearance from the UK drug regulator the Medicines and Healthcare products Regulatory Agency (MHRA), and ethical clearance from the Health Research Authority (HRA) to begin a trial of an inhaled therapy, SNG001.

And Hemel Hempstead-based EUSA Pharma said it had begun a trial of siltuximab, an antibody that also aims to tackle the severe respiratory symptoms that can occur.

Synairgen's trial will test SNG001, an inhaled formulation of interferon-beta-1a in patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus.

Synairgen did not give a timetable for the trial, but said it is due to begin “imminently”.

Interferon beta (IFN-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 of these at-risk patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections.

Viruses including coronaviruses such as SARS-CoV-2 have evolved mechanisms to suppress the body’s production of IFN-beta, helping the virus evade the innate immune system.

Adding inhaled IFN-beta before or during viral infection could prevent or diminish cell damage and viral replication.

SNG001 is formulated to be delivered directly to the lungs via nebulisation and has already showed promise in two phase 2 clinical trials in asthma, where it improved lung function with a respiratory viral infection.

The drug was also identified by the World Health Organisation in its landscape analysis of potential therapies for the coronavirus, and is the only phase 2 or phase 3 observational therapy delivered by the inhaled route.

EUSA working with Italian hospital

EUSA Pharma said it had begun a trial of a hospital-sponsored study of siltuximab with Papa Giovanni XXIII Hospital in Bergamo, Italy, which has been hit hard by the disease.

Siltuximab is an interleukin (IL)-6 targeted monoclonal antibody, for patients with COVID-19 who have developed serious respiratory complications

The SISCO Study is an observational case-control trial, from data collected and analysed from patients treated under an ongoing emergency compassionate use protocol.

The study will investigate two cohorts retrospectively, hospitalised patients prior to admission to an intensive care unit (ICU) or patients already requiring intensive care, and will compare to matched controls.

Primary endpoints are reduction in the need of invasive ventilation, time spent in ICU or 30-day mortality.

The rationale for the study is that exacerbated production of the inflammatory cytokine IL-6 is associated with the severe symptoms associated with the Acute Respiratory Distress Syndrome (ARDS) that can occur in infected patients.

Initial data are expected later this month and further studies are planned to test efficacy in patients with COVID-19 who develop serious respiratory complications

Steve Bates, CEO of the UK’s life sciences trade body, the BioIndustry Association (BIA), said: "This shows the speed at which our ecosystem can move; linking SMEs, the established UK clinical trials infrastructure of the NHS and an enabling regulator in the UK’s MHRA.

“The sector is also working flat out on innovative emergent ventilator capacity, novel vaccine scale-up capacity, new ways to support NHS patients at home with digital products and investigating antibody technology for therapeutic use."