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Evgen Pharma to advance SFX-01 trial with University of Dundee

By Josh White

Date: Thursday 05 Dec 2019

Evgen Pharma to advance SFX-01 trial with University of Dundee

(Sharecast News) - Clinical-stage drug development company Evgen Pharma has entered into a memorandum of understanding with the University of Dundee, it announced on Thursday, to advance SFX-01 towards a clinical trial in non-alcoholic steatohepatitis (NASH) and liver fibrosis.
The AIM-traded firm said it had agreed to supply SFX-01 to support a potential future clinical trial led by John Dillon, professor of hepatology and gastroenterology in the university's School of Medicine.

With the assistance of Evgen, professor Dillon would lead the process to secure appropriate grant funding and obtain clinical trial regulatory approval.

The intention was to utilise advanced MRI scanning technology to investigate whether SFX-01 could reverse the hallmarks of NASH in a proof-of-concept clinical trial.

Clinical data arising from a successful trial would support subsequent development, regulatory approval and commercialisation of SFX-01 in NASH and liver fibrosis.

Evgen said it would be granted an option to the clinical data on fair commercial terms, to enable it to advance development and commercialisation.

The company noted that non-alcoholic fatty liver disease (NAFLD) is now regarded as the most common liver condition in the developed world, affecting up to 30% of the general population.

It represented a spectrum of phenotypes, ranging from simple steatosis - or fatty infiltration - through NASH to cirrhosis.

Approximately 30% of adults in the general population had NAFLD, and between 10% and 20% of those had NASH.

Among patients with NASH, between 20% and 30% were at risk of developing cirrhosis, and subsequently dying from end-stage liver disease within 20 years.

In view of the "tens of thousands" of individuals who were likely to develop NASH in the next decade, Evgen said it was clear that the disease would represent a "major burden" to healthcare in the UK.

It noted that professor John Dillon and colleagues had previously published research that showed that drug-induced activation of the Nrf2 pathway could reverse insulin resistance, suppress hepatic steatosis, and mitigated against NASH and liver fibrosis.

On this basis, he approached Evgen, the developer of SFX-01, a development stage drug that is known to activate the Nrf2 pathway and has demonstrated excellent safety and tolerability in previous clinical trials.

"We are delighted that Evgen will support our plans to undertake a clinical trial on SFX-01 in patients with NASH," said professor John Dillon.

"Oxidative stress is pivotal to the development of NASH and our research suggests that activation of the Nrf2 pathway, which in turn reduces oxidative stress, can reverse the pathology."

Dr Stephen Franklin, chief executive officer of Evgen Pharma, added that as a result of the successful fundraise in April, the company was now in a position to be able to expand the toxicology package for SFX-01, which was a prerequisite to being able to support the trial design proposed by professor Dillon and colleagues.

"We are particularly excited by this trial design because of the use of advanced MRI imaging of the liver which will give an objective measure of the extent to which SFX-01 can modulate the pathology of the disease."

At 1552 GMT, shares in Evgen Pharma were up 0.67% at 7.5p.

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