GENFIT initiates clinical study of nonalcoholic fatty liver in children January 24, 2018 Source: Sina Pharmaceutical On January 23, GENFIT, a leading research and development company for therapeutic and diagnostic solutions for metabolic and inflammatory diseases (especially diseases affecting the liver or gastrointestinal system), officially announced that elafibranor will be used for non-alcoholic fatty liver disease (NASH) children. Clinical research work for treatment. The drug is an agonist of peroxisome proliferator-activated receptor-alpha (PPARA) and receptor-delta (PPARD), which improves insulin sensitivity, blood glucose balance, lipid metabolism, and reduces inflammation. This clinical study decision is based on the FDA's approval of elafibranor's preliminary research program (PSP) for NASH children's clinical trials in the United States. The FDA's PSP agreement will allow GENFIT to initiate the first pediatric trial to assess the safety and efficacy of elafibranor in NASH children. The approval of the Pediatric Trial Supervision Agreement shows that the review experts are confident in elafibranor, which is mainly due to the positive results of the clinical 2b study of the drug in adult NASH patients. The results, already published in Gastroenterology, do show elafibranor's unique safety and effectiveness potential, including: 1. Histological efficacy: In the 52-week clinical trial, NASH treatment did not aggravate fibrosis (as defined in the clinical phase 3 trial protocol) 2. Decreased risk factors for cardiovascular metabolism: (lipids, insulin resistance, glucose homeostasis, inflammation), a basic clinical benefit for NASH patients who die primarily from cardiovascular disease. 3. Safety: The key requirements for any chronic disease treatment, including NASH. 4. Good tolerance: The main advantage of the NASH treatment process. The rise in the number of obesity and type 2 diabetes worldwide is becoming an important public issue affecting public health. Gastroenterologists and liver disease specialists are at the forefront of managing the treatment of these epidemics, including onset treatment in pediatric populations. The diagnosis rate of fatty liver disease (NAFLD) is getting higher and higher, and it is also the most common disease in children with liver abnormalities. In children, NAFLD is associated with insulin resistance and hypertriglyceridemia. NAFLD is considered to be a liver manifestation of metabolic syndrome, and all overweight or obese children and adolescents are at risk for NAFLD. Many children are gradually suffering from severe liver disease due to obesity, insulin resistance and overweight. As shown in the numbers below: 1. Between 1988 and 2010, the rate of abnormal liver function (ALT elevation) in children and adolescents in the United States tripled from 3.9% to 10.7%. Based on the rate of increase in ALT, an estimated 10% of American children have NAFLD, one third of whom may be NASH and 17% may have fibrosis. 2. A study of obese children showed that children with metabolic syndrome were three times more likely to develop NAFLD than children without metabolic syndrome. 3. A recent study showed a statistically significant difference between NASH and NAFL, suggesting an increased risk of CVD (bad cardiovascular events) in children with NASH. These figures confirm the enormous unmet need for treatment in children, and there are currently no approved NAFLD/NASH medications, even for adults. The primary goal of treating pediatric NAFLD is to prevent and reverse liver damage. The ultimate goal is to improve the quality of life of children by reducing the long-term morbidity and mortality associated with metabolic outcomes of fatty liver disease, and to prevent progression toward cirrhosis and its complications. Dr. Joel Lavine, President of the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) NASH Clinical Research Network Pathology Society, Pediatric Gastrointestinal/Liver/Nutrition Department, New York Presbyterian Children's Hospital, commented: "NASH in the Children's Population" It has become a growing concern of liver diseases and gastrointestinalologists worldwide. The rise in childhood obesity has directly led to a sharp increase in the prevalence of NAFLD. Obesity, pre-diabetes, overweight, insulin resistant children and children of certain races are particularly vulnerable. Affected. I am looking forward to the first clinical trial of elafibranor in children, because the safety of the drug and the extra cardiac metabolism clearly meet the therapeutic needs of these children with metabolic disorders. These patients lack effective treatment. In the case of advanced fibrosis, type 2 diabetes, and cardiovascular disease, the FDA's approval of PSP is a key step in achieving treatment for children in the United States." Dr. Sophie Mégnien, Chief Medical Officer of GENFIT, said: “We are excited about the FDA's approval of the elafibranor Pediatric Research Program. Most importantly, it allows us to conduct pediatric clinical trials in the US. Many NASH children and adolescents urgently need an effective treatment plan. Therefore, obtaining new data on elafibranor in pediatric treatment is crucial. We hope to obtain clear evidence of efficacy to demonstrate that the drug may address unmet clinical needs in a specific population." Elafibranor (GFT 505) is a pipeline product led by GENFIT. This is a once-a-day oral medication that is positioned as the world's first drug to treat NASH. The drug is currently undergoing a critical clinical study, RESOLVE-IT, which aims to obtain conditional market approvals using a single histological surrogate endpoint through mid-term analysis of 1,000 patients. (Sina Pharmaceutical Compilation / David) Article reference source: GENFIT: Official Launch of the NASH Pediatric Program, following PIP and PSP Agreement by EMA and FDA Longtail tuna,long tail tuna eating quality,longtail tuna eating quality Zhoushan Boda Aquatic Products Co.,Ltd , https://www.baida-aquatic.com