Evgen makes progress with recruitment in 'STAR' trial

Clinical stage drug development company Evgen Pharma said on Wednesday that a total of 102 patients had been recruited and randomised to the ‘STAR’, or ‘SFX-01 Treatment for Acute Respiratory infections’, trial.

The AIM-traded firm said the phase 2 and 3 trial is a randomised, placebo-controlled trial, sponsored by the University of Dundee and funded by the UK charity LifeArc.

It was investigating whether the company's 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 be included in the study if they were infected with SARS-CoV-2, or another respiratory infection causing community-acquired pneumonia.

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.

In addition to the board safety and futility assessment, the University of Dundee had decided to review the top-level unblinded data in a preliminary assessment of possible efficacy.

That could lead to adjustments to the design of the trial for remaining patients, including in patient numbers, and possibly early termination for either safety, futility or alternatively, strong efficacy.

It was expected that the initial data would be available during the second quarter of 2021.

The university also requested that the monitoring board review data from the first 60 patients solely for safety and this process would start shortly, with the outcome of that expected to be available early in the second quarter.

Completion of recruitment to the STAR trial was anticipated at the end of 2021 or in the first quarter of 2022, assuming there were no substantial changes in the total patients to be recruited.

“Randomising over 100 patients is an important milestone in this trial and takes us a step closer to receiving the initial data from the study,” said chief executive officer Dr Huw Jones.

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

At 1453 GMT, shares in Evgen Pharm were up 0.53% at 9.5p.