Evgen Pharma makes progress with 'STAR' trial recruitment

Clinical-stage drug development company Evgen Pharma said on Tuesday that as of 18 January, a total of 56 patients had been recruited and randomised to the ‘STAR’ trial.

The AIM-traded firm said the phase 2 and 3 randomised, placebo-controlled trial was being sponsored by the University of Dundee, and funded by the UK charity Life Arc.

It said it would investigate whether the company's lead asset, SFX-01, could reduce the severity, or prevent the onset of, acute respiratory distress syndrome in patients with community-acquired pneumonia from any infective agent, and who had been or were being tested for suspected Covid-19.

Patients could thus present with Covid-19, or other respiratory diseases.

The board said the trial design included an assessment of safety and futility by a data safety and monitoring board, which would review unblinded data on the first 100 patients treated.

An announcement would be made when that point was reached.

Evgen explained that 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.

It said preclinical studies showed that up-regulating the Nrf2 pathway had the potential to reduce the severity of acute respiratory distress syndrome, 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.

“We are pleased with the recruitment progress in this trial and would like to thank professor James Chalmers and his colleagues at Dundee for their considerable efforts in a difficult clinical environment,” said chief executive officer Dr Huw Jones.

“We are greatly encouraged by recent academic papers which reinforce previous preclinical data showing the potential benefit to ARDS patients of up-regulating Nrf2 and hope that SFX-01 may be a valuable addition to the array of treatments that these seriously ill patients can receive.

“We look forward to further updating the market as we progress through this important trial.”

At 1450 GMT, shares in Evgen Pharma were down 2.44% at 10p.