Southampton COVID-19 drug enters large scale trials

covid-19-4961257_640

COVID-19 therapy  inhaled interferon beta has entered into large-scale international trials, following early phase results indicating it could prevent patients’ decline, cutting ICU usage and improving recovery times.

The first patient has received a treatment developed by University of Southampton spin-out Synairgen that could prevent patients hospitalised with COVID-19 from getting worse, in a new large-scale trial.

The treatment – a fine mist of the protein interferon beta breathed deep into the lungs – is thought to help prevent COVID-19 getting worse by boosting the lungs’ antiviral defences and preventing lung damage. In early stage trials, it reduced hospitalised COVID-19 patients’ odds of developing severe symptoms by up to 80%, avoiding intensive care and saw a doubling of those that were discharged in the two weeks following treatment.

This larger phase 3 trial, led by Professor Tom Wilkinson, respiratory research theme lead of the NIHR Southampton Biomedical Research Centre in collaboration with Synairgen, will build on these early findings to involve more than 600 patients in 20 countries.

Protecting hospital patients

Alexandra Constantin, 34, was the first person to receive the treatment as part of this new trial, after she was admitted to the hospital with coronavirus on Monday.

She received the treatment at Hull Royal Infirmary on Tuesday afternoon, where she was asked to breathe the drug deeply into her lungs using a nebuliser – a machine that converts it into a fine mist.

A course of treatment with the new drug could cost around £2,000, which is not that expensive for a hospital treatment. If successful, the researchers expect it could be approved for use in the summer.

“We need treatments as well as vaccines to fight highly pathogenic viruses such as SARS-CoV-2,” commented Richard Marsden, CEO of Synairgen. “

“Development of treatments like ours will remain necessary in cases where vaccines are not effective, for those who do not get vaccinated, and in case the virus mutates to the point where vaccines become less effective.

“We believe this trial presents an opportunity for a significant UK scientific breakthrough and, if given the right support, our drug could rapidly assist with the global crisis.”

Promising early results

Early findings suggest the treatment could cut the odds of a COVID-19 patient developing severe disease - such as requiring ventilation - by almost 80%.

The research was led by Professor Tom Wilkinson in collaboration with Synairgen, a respiratory drug discovery and development company founded by the University of Southampton professors Stephen Holgate, Donna Davies and Ratko Djukanovic.

The results of their previous phase 2 trial, involving 100 COVID-19 patients from nine UK hospitals, found those who received the drug had reduced breathlessness and were more than twice as likely to recover to the point where their everyday activities were not hindered by the illness.

They have also shown that the drug can stimulate an immune response, and that patients with asthma and other chronic lung conditions can comfortably tolerate the treatment.

Immune boost

Interferon beta is a protein that occurs naturally in the body with antiviral properties. It is commonly given as an injection in the treatment of multiple sclerosis.

There is evidence that older people and people with some chronic health conditions have poorer interferon beta responses, and also that the virus that causes COVID-19 suppresses interferon beta production by cells in the body.

It is thought that breathing it in as a fine mist boosts the lung’s immune response – enhancing protection, accelerating patients’ recovery and countering the impact of the virus.

Synairgen is also running an ongoing Phase II trial of inhaled interferon beta in non-hospitalised ‘at risk’ patients. For more information and to take part, visit www.covidtrialathome.com.

Posted on Monday 18 January 2021