This Phase II/III trial is a randomised, placebo-controlled trial, sponsored by the University of Dundee and funded by the UK charity LifeArc, the drug developer said.
It is investigating whether the company’s lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome in patients with suspected COVID-19.
Patients may be included in the study if they are infected with SARS-CoV-2 or other respiratory infections causing community-acquired pneumonia, the AIM-listed firm added.
The trial design includes an assessment of safety and futility by a Data Safety and Monitoring Board (DSMB) who will review unblinded data on the first 100 patients treated.
In addition to the DSMB safety and futility assessment, Dundee University has decided to review the top-level unblinded data in a preliminary assessment of possible efficacy.
This may 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, Evgen said.
It is expected that this initial data will be available during the second quarter of calendar 2021.
The university has also requested the DSMB review data from the first 60 patients solely for safety and this process will be starting shortly, with an outcome expected to be available early in the second quarter.
The pharma company said that completion of recruitment to the STAR trial is anticipated at the end of the year, assuming there are 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 Dr Huw Jones in a release.