SFX‐01 to enter Phase II/III trials to test efficacy against COVID-19 symptoms

Evgen Pharma has announced that its product candidate, SFX‐01, has been selected for evaluation in a randomised Phase II/III trial to be sponsored by the University of Dundee, UK. According to the company, the trial will investigate whether SFX‐01 can reduce the severity, or prevent the onset of, acute respiratory distress syndrome (ARDS) associated with COVID‐19, reducing the need for invasive patient ventilation and potentially improving recovery times.

The company says that SFX‐01 up-regulates 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. Pre-clinical 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 (ICU).

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. The study is expected to begin enrolment in July and results are expected in 2021.

Professor James Chalmers, Principal Investigator on the trial, said: “SFX‐01 is an anti‐inflammatory medication that we believe may have the potential to reduce some of the worst outcomes of COVID‐19. Early treatment with an Nrf2 activator in patients hospitalised with COVID‐19 may prevent deterioration and help to preserve precious ICU resources in the context of the pandemic. This is a completely new mechanism as there is currently no drug that targets Nrf2.”

Barry Clare, Executive Chairman of Evgen, said: ”We are delighted to be supporting Dundee University in this trial which we fervently hope will lead to an additional treatment for COVID‐19 patients. We are excited that, as a proven activator of the Nrf2 pathway, SFX‐01 could be of significance in the COVID‐19 pandemic.”