Biomarkers in NASH Drug Development: Using Cytokeratin 18 as a Secondary Endpoint in Clinical Trials, New Webinar Hosted by Xtalks

TORONTO, October 3, 2018 (Newswire.com) - Join Naim Alkhouri, MD, Associate Professor of Medicine at the Division of Gastroenterology and Adult & Pediatric Hepatologist for the Liver Transplant Program at the Texas Liver Institute as well as industry experts from Celerion Sabina Paglialunga, PhD, Associate Director of Scientific Affairs and Sumit Kar, Lead Scientist for Biomarkers in Bioanalytical Services, for an interactive live webinar. This complimentary presentation is upcoming on Monday, October 22, 2018, at 11 a.m. EDT (4 p.m. BST/UK).

Non-alcoholic fatty liver disease (NAFLD) is a medical condition characterized by the build-up of fat in the liver. NAFLD has a spectrum that ranges from steatosis and non-alcoholic steatohepatitis (NASH) to fibrotic NASH and cirrhosis. The prevalence of NAFLD worldwide is reported to be 20-35%, and it is strongly connected to the global epidemic of obesity and type 2 diabetes. In the United States NAFLD is the most common form of the chronic liver disease and a leading indication for liver transplantation. There are currently no approved drug therapies for NAFLD or NASH, and many clinical trials are underway to address this unmet need for pharmacologic treatment options.

Liver biopsy is still considered the “gold standard” for diagnosis of NASH, and histological endpoints are currently required by the FDA for approval of NASH drugs. However, liver biopsy has many drawbacks, including sampling error, cost, the risk of complications, and patient acceptability. Because of these limitations and concerns regarding liver biopsy, non-invasive biomarkers are urgently needed not just to identify subjects with NASH, but also to determine their response to novel therapeutic agents.

Markers of hepatic injury or cell death such as cytokeratin 18 (CK18 or K18) and its caspase-cleaved fragment, cCK18, have been suggested as endpoints for early clinical drug trials where histological assessments are not feasible. The M30 Apoptosense® ELISA is a specific and reliable tool to measure the concentration of cCK18 fragments. Biomarker assays used for drug development should be validated and run in a bioanalytical lab based on the context of use of the biomarker. Celerion has validated the M30 Apoptosense® ELISA for use as a secondary endpoint in NASH clinical trials.

To learn more about this complimentary event visit: Biomarkers in NASH Drug Development: Using Cytokeratin 18 as a Secondary Endpoint in Clinical Trials.

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Source: Xtalks