Evgen Pharma has received full regulatory approval for its STAR trial, which will investigate the company’s lead asset to treat acute respiratory distress syndrome (ARDS) in patients with suspected COVID-19.

The STAR study will investigate whether the candidate, SFX-01, can reduce the severity or prevent the onset of ARDS in suspected COVID-19 patients.

Patients could be drawn from both hospital and community settings, and may present with COVID-19 or other respiratory diseases.

SFX-01 is designed to up-regulate the Nrf2 pathway, which is part of the natural human defence against inflammatory and oxidative stress, such as the inflammation that occurs during a severe viral infection.

In preclinical studies, up-regulating the Nrf2 pathway has been shown to reduce the severity of ARDS, the progressive lung damage observed in both COVID-19 and pneumonia patients.

The study is being supported by a grant from LifeArc and is being led by professor James Chalmers, British Lung Foundation professor of respiratory research at the University of Dundee.

“Receiving full regulatory approval is a significant step forward for us. We look forward to the start of recruitment for the trial shortly with our partner,” said Huw Jones, chief executive officer of Evgen.

“We hope that the outcome of this trial will lead to an additional treatment for COVID-19 patients and that SFX-01 could play a big part in managing the current pandemic,” he added.