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Phase IIb/III

Patient recruitment commenced in early December 2020 on the STAR trial (SFX-01 treatment for Acute Respiratory Infections).

This trial will investigate whether the Company’s lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome ARDS in patients with community-acquired pneumonia who have been or are being tested for suspected COVID-19.   Patients may therefore present with COVID-19 or other respiratory diseases.

The trial is being led by Professor James Chalmers, British Lung Foundation Professor of Respiratory Research at the University of Dundee. The study will recruit up to 300 patients with confirmed or suspected COVID-19 from hospitals across the UK. Half the group will receive SFX-01 in addition to standard hospital care while the other half will receive a placebo and standard hospital care. 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.

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

The trial is being funded by the LifeArc medical charity following a competitive application process.