Evgen gets full approval for SFX-01 trial in Covid-19 patients

Clinical-stage drug development company Evgen Pharma announced on Friday that all necessary regulatory approvals had now been received for the ‘STAR’ trial of SFX-01 treatment for Acute Respiratory Infections.

The AIM-traded firm said trial recruitment was expected to begin around the end of the month.

It described STAR as a phase 2 and 3 trial to investigate whether its lead asset, SFX-01, could reduce the severity, or prevent the onset of, acute respiratory distress syndrome in patients with suspected Covid-19.

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

It would be a randomised, placebo-controlled trial, and was being sponsored by the University of Dundee.

Evgen said SFX-01 upregulates 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.

Preclinical studies showed that up-regulating the Nrf2 pathway reduced the severity of acute respiratory distress syndrome, being the progressive lung damage observed in Covid-19 and pneumonia patients, which could result in the need for invasive ventilation in an intensive care unit.

The clinical study was being supported by a grant from LifeArc, as the company announced in June, and was being led by professor James Chalmers, the British Lung Foundation professor of respiratory research at the University of Dundee.

The results were expected in 2021.

Evgen said it would supply clinical centres with SFX-01 and a placebo as its contribution to the trial.

No additional financing was required, as the costs of providing SFX-01 for the trial were not material.

“Receiving full regulatory approval is a significant step forward for us,” said chief executive officer Dr Huw Jones.

“We look forward to the start of recruitment for the trial shortly with our partner.

“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.”

At 1132 BST, shares in Evgen Pharma were up 7.47% at 13.3p.