University of Dundee to establish potential of investigational compound to improve outcomes in COVID-19 progression in trial of 300 patients
A randomised, double-blind, placebo-controlled trial of SFX-01 or placebo on a backbone of best standard care, to improve outcomes in COVID-19 progression
University of Dundee and Evgen Pharma PLC, with funding from LifeArc, are set to commence clinical trial testing of an investigational medicinal product in 300 hospitalised COVID-19 patients. Researchers have identified that one of Evgen’s existing products, SFX-01, could reduce the impact of COVID-19 disease by preventing Acute Respiratory Distress Syndrome (ARDS), a common and often deadly symptom of severe cases of COVID-19.
Potential of repurposed therapeutic for COVID-19 pandemic
A major challenge in the treatment of COVID-19 is the development of slowly worsening lung damage, known as Acute Respiratory Distress Syndrome (ARDS). This requires intensive care treatment with ventilation until the inflammation is resolved and the lungs can heal.
Nrf2 is a transcription factor (a naturally-occurring protein) which forms part of the body’s defences against inflammatory and oxidative stress, such as the inflammation that occurs during a severe viral infection. It is hypothesised that increasing the levels of active Nrf2 in patients with COVID-19 could improve recovery and prevent the need for ventilation.
SFX-01, a stable form of the natural compound sulforaphane, is an orally administered investigational medicinal product that activates Nrf2 and has been tested in over 130 patients to date in clinical trials (in healthy volunteers and patients suffering from breast cancer or a rare type of brain haemorrhage).
Researchers secured funding from LifeArc to conduct an investigator led, prospective, randomised, double-blind placebo-controlled trial, conducted in the UK, of patients hospitalised with COVID-19.
Investigating a sample size of 300 subjects, the study will compare outcomes for 300mg SFX-01 taken orally, once daily, plus best standard of care (BSC) versus placebo taken orally, once daily plus BSC. The primary outcome of the trial is the clinical status of patients on day 15 based on a seven point scale, recommended by the World Health Organisation as the optimal clinical trial endpoint for COVID-19 studies.
The trial will be conducted in up to six sites across Scotland and the north of England with first patient visit anticipated to happen in July.