A pioneering European research project with assistance from a Virginia Commonwealth University clinician aims to lead to new diagnostic tests to assess patients with non-alcoholic fatty liver disease and identify those most at risk for developing severe inflammation and liver scarring.

The $40 million (€34 million) project, Liver Investigation: Testing Marker Utility in Steatohepatitis, is funded by the European Innovative Medicines Initiative 2 Joint Undertaking and brings together clinicians and scientists from prominent academic centers across Europe with companies from the European Federation of Pharmaceutical Industries and Associations. Their common goals are developing, validating and qualifying better biomarkers for testing NAFLD.

The project is coordinated by Newcastle University, UK, working closely with the lead EFPIA partner, Pfizer. LITMUS will include 47 international research partners based at leading international universities and some of the world’s largest pharmaceutical companies.

Through his appointment as a visiting professor at Newcastle University, VCU Health hepatologist Arun Sanyal, M.D., is an adviser to the LITMUS project.

“This is a very important project which will allow physicians to diagnose those who have this dangerous kind of fatty liver disease,” he said. “Currently the only way to do that is with a liver biopsy, which is painful, invasive and carries some risk.”

Affecting 20 to 30 percent of the population worldwide, NAFLD is caused by a build-up of fat in liver cells, which leads to inflammation, scarring of the liver and ultimately cirrhosis. It is strongly linked to obesity and Type 2 diabetes.

Quentin Anstee, a professor at Newcastle University’s Institute of Cellular Medicine and a consultant hepatologist at Newcastle Hospitals NHS Foundation Trust, is coordinating the LITMUS consortium.

“Non-alcoholic fatty liver disease is already the most common underlying cause of liver transplant in the United States and, with the obesity epidemic in Europe, we are very close behind,” he said. “LITMUS will unite clinicians and academic experts from centers across Europe with scientists from the leading pharmaceutical companies, all working together to develop and validate new highly-accurate blood tests and imaging techniques that can diagnose the severity of liver disease, predict how each patient’s disease will progress and monitor those changes, better or worse, as they occur.”

“Lack of easy and accurate diagnostic tests means that many patients go undiagnosed until late in the disease process. It has also held back efforts to develop new medical treatments for NAFLD,” Anstee said. “Availability of better diagnostic tests will help us to target care at an early stage of disease to the people who are going to be most severely affected. It will also help us to develop more effective medical treatments for NAFLD and to run the clinical trials that the regulatory agencies need so that they can license these medicines to be prescribed by doctors.”

Chris Day, vice-chancellor and president of Newcastle University and a consultant hepatologist, added, “Tackling non-alcoholic fatty liver disease is a major public health challenge and the award of such a large grant from the EU, allowing us to bring together pharma and academia in this way, gives us real hope of making significant advances in the diagnosis and treatment of this increasingly common and often devastating disease."

If studies in Europe identify noninvasive methods that properly recognize patients at risk for developing liver cirrhosis, those results will need to be validated in the United States. VCU Health will be one of two sites where that will happen, Sanyal said.

Julia Brosnan, senior director of external collaborations and scientific alliances at Pfizer, who also serves as the industry project lead for LITMUS, expressed enthusiasm about the good the collaboration will do.  

“This is an exciting project and we look forward to working with the other LITMUS partners to develop new diagnostic tests for NAFLD, which is too often undiagnosed in patients,” she said. “We hope the results of this project will help change that.”

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777377. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

NOTES FOR EDITORS

Professor Quentin Anstee:

http://www.ncl.ac.uk/icm/people/profile/quentinanstee.html#background

Twitter: @LITMUS_IMI

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777377. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and 47 Associated Partners: AMC Amsterdam, Antaros, Antwerp University Hospital, Boehringer-Ingelheim, Center for Cooperative Research in Biosciences, Ellegaard Göttingen Minipigs, European Association for the Study of the Liver, Exalenz Bioscience, Faculdade de Medicina de Lisboa, Genfit, Hôpital Beaujon, APHP, Institute of Cardiometabolism And Nutrition, Integrated Biobank of Luxembourg, Intercept, iXscient, Lilly, Linköping University, Medical University of Vienna, National & Kapodistrian University of Athens, Newcastle University, Nordic Bioscience, Novartis Pharma AG, Novo Nordisk, Örebro University, OWL, Perspectum Diagnostics, Pfizer Ltd., RWTH Aachen University Hospital, Sanofi, Servicio Andaluz de Salud, Seville, Somalogic, Takeda Pharmaceuticals International GmbH, UMC Utrecht, Università Cattolica del Sacro Cuore, Università degli Studi di Milano, Università degli Studi di Palermo, University Hospital of Angers, University Hospital Würzburg, University Hospitals Birmingham NHS Foundation Trust, University Medical Center Mainz, University of Bern, University of Cambridge, University of Helsinki, University of Lisbon, University of Nottingham, University of Oxford, University of Torino

This release is the author's view and that neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.