By Sheila Mckenzie-
University of Dundee is funding Clinical-stage trials with drug development company Evgen Pharma for the medical research charity LifeArc on Wednesday.
The AIM-traded firm’s lead product candidate ‘SFX-01’ has been selected for evaluation in a randomised phase 2 and 3 trial.The clinical study is being supported by a grant from LifeArc, as part of its activities to address the need for new therapies for Covid-19, The Eye Of Media.Com has heard.
LifeArc has made £10m available to repurpose existing medicines, or those in the late stage of development, as that approach offered “one of the fastest routes” to develop new treatments that could tackle the virus and its impact, Evgen explained.
Life Arc says it received more than 130 in-scope applications for this scheme globally, and an independent panel of experts assessed shortlisted applications selected on a number of criteria, including scientific rationale of approach.
The trial aims to investigate whether SFX-01 could reduce the severity, or prevent the onset of, acute respiratory distress syndrome associated with Covid-19, thus reducing the need for invasive patient ventilation and potentially improving recovery times.
“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,” the Evgen board explained.
“Preclinical studies have shown that up-regulating the Nrf2 pathway reduces the severity of acute respiratory distress syndrome, 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 led by professor James Chalmers, the British Lung Foundation Professor of Respiratory Research at the University of Dundee.
James Chalmers, British Lung Foundation Professor of respiratory research at the university, 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.
“The body defends itself against inflammatory and oxidative stress by increasing levels of chemical called Nrf2. SFX-01 activates the Nrf2 system and puts it into overdrive to enhance defences against inflammatory damage.
“There is evidence that Nrf2 activation can reduce the severity of acute lung injury and ARDS.”
Recruitment
The study plans to recruit up to 300 patients with confirmed or suspected Covid-19 from hospitals across the UK.
Half the group would receive SFX-01 in addition to standard hospital care, while the other half would receive a placebo and standard hospital care.
Evgen said it would supply clinical centres with SFX-01 and a placebo as its contribution to the trial
“SFX-01 is an anti-inflammatory medication that we believe may have the potential to reduce some of the worst outcomes of Covid-19,” said principal investigator, professor James Chalmers.
“Early treatment with an Nrf2 activator in patients hospitalised with Covid-19 may prevent deterioration and help to preserve precious intensive care unit 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, added that the company was “delighted” to be supporting Dundee University in the trial.
“We fervently hope [it] 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.”
Professor James Chambers
Professor James Chalmers, clinical professor at the School of Medicine, said: “The only real exit strategy for the problems that we are facing today and to get back to the world we had before is to either find a new treatment or find a vaccine.
If successful, the drug would reduce the need for ventilation, meaning fewer patients needing intensive care, reducing the strain on the NHS.
Barry Clare, chairman of Evgen Pharma, said: “We have great respect for the clinical and research staff at Dundee and are delighted to be supporting the university in this trial.
“We are excited at the opportunity to test whether an Nrf2 activator such as SFX-01 may have a role in helping the recovery of Covid-19 patients.”
In April, the School of Medicine teamed up with global pharmaceutical company Insmed Incorporated to test another anti-inflammatory drug to be tested on coronavirus patients in Ninewells.
The same researchers have also secured £4 million to develop drugs to tackle coronavirus and similar future diseases which will prevent the virus itself, compared to reducing its most severe symptoms as it is hoped the anti-inflammatory trial will achieve.