Licensing Opportunities Predictive Biomarker for Pediatric Liver Disease → Obesity in children is a risk factor for non-alcoholic fatty liver disease → Early detection of liver disease enables adequate patient management → Plasma Cathepsin D levels strongly correlate with progression of liver disease and has predictive value Patent pending (PCT/EP2015/073683) Summary Liver biopsies from children (n=96) with nonalcoholic fatty liver disease (NAFLD) in various stages were correlated to plasma Cathepsin D (CatD) levels. Maastricht University found that plasma CathD gradually and consistently decreases with Increasing severity of liver disease. CatD plasma levels showed a high diagnostic accuracy for the differentiation between steatosis and hepatic inflammation. 18) and alanine aminotransferase (ALT) showed that only CathD concentrations significantly decrease with disease progression (NAS score) and correlates with the individual stages of NAFLD disease characteristics being ballooning, steatosis, inflammation and fibrosis. CathD showed a remarkably high diagnostic accuracy with a sensitivity and specificity of 100 % and 89% respectively (Walembergh et al 2015). In conclusion, plasma CatD has a high diagnostic value to distinguish liver steatosis to hepatic inflammation. Scientific Background Business opportunity The current Obesity epidemic in children is paralleled by an increasing prevalence of NAFLD, a condition characterized by early hepatic steatosis and by a more severe form known as non-alcoholic steatohepatitis (NASH). Key histological changes of NASH are steatosis, Inflammation, hepatocellular ballooning and eventually fibrosis, which in turn may progress to end stage liver disease even in young individuals. Liver disease may develop unnoticed unless determined by liver biopsy. Hence there is a critical need for specific non-invasive analysis based on predictive biomarkers for hepatic inflammation in an early stage. The prevalence of NAFLD in countries worldwide varies between 6-35 % (median 20%) and ultimately a liver transplantation is needed in one out of ten patients. Early diagnosis of NAFLD and in particular early in live will contribute to disease management. Predictive non-evasive early stage analysis is therefore very relevant to enable early as possible intervention to prevent development to end-stage liver disease. Considering the increasing fraction of obese individuals and the risk of developing liver disease, early predictive analysis represents a large market and a significant business opportunity in particular as part of multi-parameter analysis products for (risk of) liver disease or as companion diagnostic alongside pharmacologic intervention in (pediatric) liver disease. Invention disclosure Analysis of plasma in 96 children (mean age 8.9 year) with confirmed Liver Steatosis, Borderline NASH and fully developed NASH for CathD, cytokeratin-18 (CK- Exclusive Commercial rights are available for licensing and provide the opportunity to specifically market (multiparameter) analysis to identify early stage liver disease in children. > read more Page 1/2 Predictive Biomarker for Pediatric Liver Disease Contact Yvo Graus, PhD, MBA Senior Business Development Officer Brightlands Maastricht Health Campus Oxfordlaan 70 6229 EV Maastricht The Netherlands +31(0)6 4876 5408 [email protected] www.maastrichtuniversity.nl/valorisation Page 2/2
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