Evgen's 'SFX-01' to be tested with Covid-19 patients

(Sharecast News) - Clinical-stage drug development company Evgen Pharma announced its participation in the recently-notified funding initiative for Covid-19 clinical trials by the medical research charity LifeArc on Wednesday.
The AIM-traded firm said that under the scheme, its lead product candidate 'SFX-01' has been selected for evaluation in a randomised phase 2 and 3 trial, to be sponsored by the University of Dundee.

It explained that the trial would 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 was being led by professor James Chalmers, the British Lung Foundation Professor of Respiratory Research at the University of Dundee.

Evgen said the study would 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.

The study was expected to begin enrolment in July, with results anticipated in 2021.

Evgen said it would supply clinical centres with SFX-01 and a placebo as its contribution to the trial.

No additional financing was required, as the costs of providing SFX-01 for the trial were not considered material.

The clinical study was being supported by a grant from LifeArc, as part of its activities to address the need for new therapies for Covid-19.

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.

LifeArc 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.

"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."

At 1159 BST, shares in Evgen Pharma were up 12.09% at 10.2p.