New clinical study to advance development of treatments for liver cirrhosis

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The £30m ADVANCE study is the most extensive study into liver disease worldwide

A new study involving Boehringer Ingelheim, Newcastle University and the University of Edinburgh has been announced to advance the development of new treatments for liver cirrhosis.

The Accelerating Discovery: Actionable NASH Cirrhosis Endpoints (ADVANCE) study is the most extensive study into liver cirrhosis ever conducted worldwide.

Estimated to affect 444 million people globally, non-alcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) is an inflammatory liver disease caused by a build-up of fat in the liver.

Over time, NASH can cause the formation of scar tissue, which can lead to liver cirrhosis – scarring of the liver that prevents the liver from working properly.

Funded by Boehringer Ingelheim, the £30m ADVANCE study will advance understandings of the condition and help identify translational biomarkers to accelerate the development of future therapies.

Recruited from specialist liver clinics at hospitals across the UK and Europe, through referral by their treating physician, the study will involve 200 patients who have been diagnosed with or are at risk of advanced fibrosis or cirrhosis due to metabolic dysfunction-associated steatotic liver disease.

Harnessing Edinburgh University’s single cell RNA sequencing technology, small samples of liver tissue will be collected using biopsies to assess detailed changes in gene expression in the liver and patients will receive blood tests and MRI scans across the next two years.

Led by doctors at Newcastle University and Edinburgh University and scientists at Boehringer Ingelheim, all the data generated will be combined for researchers to see how disease-related changes occur and evolve in the body as cirrhosis progresses.

In addition, specialist doctors and researchers from universities and hospitals across Europe, including Belgium, France, the UK, Spain and Italy will be involved in the international consortium.

The pharmaceutical company looks forward to “better [understanding] the underlying disease processes and [bringing] much-needed new treatments to patients with liver cirrhosis” through the ADVANCE study, said Lykke Hinsch Gylvin, chief medical officer, Boehringer Ingelheim.

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