16 June 2020

Clinical trial for anti-inflammatory drug that could reduce Covid-19 deaths

16 June 2020

Researchers are to begin clinical trials of a new anti-inflammatory drug it is hoped may cut severe lung damage and deaths among Covid-19 patients.

Scientists from the University of Dundee’s School of Medicine will work with drug development company Evgen Pharma to test whether the drug, known as SFX-01, improves outcomes for patients.

Covid-19 causes the development of slowly worsening lung damage called acute respiratory distress syndrome (ARDS) in around 10% of patients admitted to hospital.

When this occurs, no currently available drug can slow the progression of ARDS and patients ultimately require mechanical ventilation in intensive care until the inflammation resolves itself and the lungs begin to heal.

SFX-01 is an anti-inflammatory medication that we believe may have the potential to reduce some of the worst outcomes of Covid-19

However, around 30% of patients with ARDS may go on to die, while the number of patients requiring ventilation for the syndrome has been one of the major challenges for health services.

Evgen Pharma develops medicines for the treatment of multiple diseases based on sulforaphane, a naturally occurring compound known to have anti-inflammatory properties, and its lead product is SFX-01, which scientists hope could help Covid-19 patients.

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 a 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.

“As such, we hypothesise that early treatment with an Nrf2 activator in patients hospitalised with Covid-19 may prevent deterioration and help to preserve precious intensive care unit (ICU) resources in the context of the pandemic.

“This is a completely new mechanism as there is currently no drug that targets Nrf2.”

Coronavirus stock (PA Wire)

The study will recruit up to 300 volunteers from hospitals across the UK, with patients offered the chance to participate immediately after their diagnosis.

Half the group will receive SFX-01 in addition to standard hospital care while the other half will receive a placebo.

The trial is due to start imminently with results expected by the end of the year.

Nrf2 is part of the human natural defence against inflammatory and oxidative stress such as the inflammation that occurs during a severe viral infection.

In animal tests, increasing the amount of available Nrf2 reduces the severity of ARDS, demonstrating its protective properties, however the university said there have so far been no human trials of SFX-01 in humans with ARDS.

SFX-01 has been shown to halt the growth of, or even shrink, tumours of breast cancer patients in clinical trials while causing very few side effects, researchers said.

Barry Clare, chairman of Evgen Pharma, said: “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.”

The research is being supported by a grant from the medical research charity LifeArc, as part of its activities to address the need for new Covid-19 therapies.

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