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The ADVANCE (Accelerating Discovery: Actionable NASH Cirrhosis Endpoints) study will be the most detailed observational study of its kind enrolling the largest number of patients and providing a detailed analysis of liver health, it involves Newcastle University, University of Edinburgh and leading research-driven global biopharmaceutical company, Boehringer Ingelheim.
This will not only enhance the understanding of NASH cirrhosis, but also help to identify translational biomarkers that will accelerate the development of future therapies.
Approximately 444 million people worldwide are estimated to live with a condition referred to as nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH), an inflammatory liver disease that is caused by accumulation of fat in the liver. Over time, NASH causes the formation of scar tissue leading in many cases to liver cirrhosis. This can result in serious complications, including liver failure or liver cancer and may result in the patient needing a liver transplant. Currently there are no approved medicines for cirrhosis and so there is an urgent need for earlier diagnosis and new medicines to prevent MASH cirrhosis progression to liver failure, or to reverse the scarring of the liver once cirrhosis is established.
This £30M study is funded by Boehringer Ingelheim and reflects the company’s commitment to improve the lives of people living with cardiovascular, renal and metabolic diseases (CRM). The study will be led by researchers at Newcastle University and the University of Edinburgh, along with collaborators across Europe.
Professor Quentin Anstee, Professor of Experimental Hepatology at Newcastle University and Consultant Hepatologist at Newcastle Hospitals NHS Foundation Trust who is coordinating the global study explained; “Building on Newcastle’s internationally recognised expertise in translational liver research, this study will reveal the fundamental disease processes driving cirrhosis”.
“We aim to work out why, even at the most advanced stages of liver disease, there is substantial variation in how the disease progresses with some people remaining well for many years whilst others rapidly experience liver failure or develop liver cancer. Working internationally with our collaborators, we will then use this knowledge to improve how patients are diagnosed, and to help develop new medicines.”
“Cardiovascular, renal, and metabolic diseases are the leading cause of death worldwide, accounting for up to 20 million deaths annually,” said Lykke Hinsch Gylvin, M.D., Chief Medical Officer at Boehringer Ingelheim. “At Boehringer Ingelheim we are focusing on understanding the whole patient and how to target specific disease mechanisms to address interconnected CRM diseases. We are very excited to work with our partners in the ADVANCE study to better understand the underlying disease processes and to bring much needed new treatments to patients with liver cirrhosis.”
Professor Neil Henderson, Professor of Tissue Repair and Regeneration at the University of Edinburgh and co-lead on the study, said; “Liver disease has reached epidemic proportions worldwide. Therefore, there is a huge need to develop potent, new treatments for liver scarring. To help address this, over the last several years we have harnessed a new technology in Edinburgh called single cell RNA sequencing. Using this new technology has allowed us to study human liver scarring in high definition for the first time, and we hope that this state-of-the-art approach will allow us to accelerate the discovery of much-needed new treatments for patients with liver disease.” His team is being supported by Edinburgh Innovations, the University’s commercialisation service.