Celerion, a leader in early clinical research, has announced the implementation of FibroScan to complement a suite of soluble biomarkers Celerion has validated to support nonalcoholic steatohepatitis (NASH) clinical studies. This combined approach enables Celerion to provide cutting-edge science, faster.
NASH is a chronic disease that can progress to cirrhosis, liver decompensation and potentially cancer. With a rising prevalence of the disease and no FDA-approved treatment, there is interest around non-invasive NASH biomarkers for disease diagnosis and clinical trial inclusion criteria. Non-invasive imaging techniques such as FibroScan hold several advantages over the standard liver needle biopsy which has poor patient acceptance, risk of complications and may not be appropriate for short study durations as typically observed in early clinical trials.
FibroScan is now available at both of Celerion's U.S. clinics in Lincoln, Nebraska and Tempe, Arizona. FibroScan is a non-invasive, ultrasound-like device that painlessly and quickly measures liver fat and fibrosis, two key components of NASH. Capturing liver fat and fibrosis with FibroScan as well as soluble biomarkers of hepatic inflammation and injury such as interleukins, TNFα and CK18, will enhance participant eligibility for early NASH studies and enable evaluation of a treatment response through non-invasive means.
“By using a multi-modality approach to characterise participants, we are able to identify the best-qualified participants for the development of future medications to treat NASH,” said Phil Bach, vice president, global clinical research at Celerion.
Ray Farmen, vice president, global bioanalytical sciences at Celerion said: “Expanding our NASH capabilities to include soluble biomarkers and imaging endpoints enables us to provide our clients with efficacy signals earlier in their program, capturing all liver fat, fibrosis and inflammation endpoints.”