Evgen Pharma (AIM: EVG)  has been given the green light to kick-start its STAR trial which will investigate whether its lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome ("ARDS") in patients with suspected COVID-19.

The clinical stage drug development firm said all necessary regulatory approvals have been received and that trial recruitment is expected to commence around the end of the month.

The randomised, placebo-controlled trial is sponsored by the University of Dundee. Patients will be drawn from hospital and community settings with COVID-19 or respiratory diseases.

SFX-01 upregulates the Nrf2 pathway, part of the natural human defence against inflammatory and oxidative stress, such as inflammation during a severe viral infection.

Shares in Evgen Pharma have climbed 20% from the beginning of the month to open 11.92% higher this morning at 13.85p following the announcement.

To date, preclinical studies have shown that up-regulating the Nrf2 pathway reduces the severity of ARDS, the progressive lung damage observed in COVID-19 and pneumonia patients, which can result in the need for invasive ventilation in an intensive care unit.

The clinical study is being supported by a grant from LifeArc, as previously announced in June 2020, and is being led by Professor James Chalmers, British Lung Foundation Professor of Respiratory Research at the University of Dundee. The results are expected in 2021.

Evgen will supply clinical centres with SFX-01 and a placebo as its contribution to the trial. No additional financing is required as the costs of providing SFX-01 for the trial are not material.

 "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 CEO, Dr Huw Jones.

He added, “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."

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