LG Chem Announces First Subject Enrolled in Phase 1 Clinical Trial of NASH New Drug
July 14, 2022CAMBRIDGE, Mass.–(BUSINESS WIRE)–#NASH–LG Chem recently announced the enrollment of first subject in Phase 1 clinical trial of LG203003, LG Chem’s second NASH (non-alcoholic steatohepatitis) drug in development.
LG203003 received clearance from the U.S. Food and Drug Administration (FDA) in March 2022 for the Company’s Investigational New Drug (IND) application to conduct Phase 1 clinical trial in 88 subjects including healthy adults and patients with non-alcoholic fatty liver disease (NAFLD). First subject was dosed on July 6, 2022, and the trial will evaluate the safety, tolerability, as well as the pharmacokinetics (PK) and pharmacodynamics (PD) of LG203003.
NASH is the most advanced form of NAFLD (inflammation of liver caused by the build-up of extra fat in liver cells that is not caused by alcohol consumption), and it is a chronic, progressive disease characterized by fatty liver, liver cell injury and fibrosis. NASH is the major cause of liver cirrhosis, liver transplantation, and HCC (hepatocellular carcinoma) in western countries.
LG203003 is the second NASH compound in LG Chem Life Sciences’ pipeline, and it is formulated to suppress the accumulation of fat in liver cells by selectively impeding the activation of DGAT2 (diacylglycerol O-acyltransferase 2), a triglyceride synthetase, thus reducing liver cell damage. In various pre-clinical models, LG203003 showed to significantly decrease triglyceride, inflammation, and fibrosis in liver.
NASH prevalence in the U.S. is projected to increase by 63 percent between 2015 and 2030¹, and it is forecasted to become the major indication for liver transplantation between 2020 and 2025². Currently, there are no FDA-approved NASH treatments in the market, and according to GlobalData, global NASH market is estimated to reach at a market value of $27.2 billion by 2029.
Dr. Peter Hong, President of LG Chem Life Sciences Innovation Center, stated, “NASH is a very challenging disease marked by complex pathophysiology, so we are excited to have 2 assets in the clinic: VAP1 inhibitor LG303174 and DGAT2 inhibitor LG203003. We are committed to addressing the challenges through bringing multiple treatment options to patients with NASH.”
| 1 |
Estes C, Razavi H, Loomba R, et al. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 2018;67(1):123-133. |
| 2 |
Wong RJ, Aguilar M, Cheung R, et al. Nonalcoholic steatohepatitis is the second leading etiology of liver disease among adults awaiting liver transplantation in the United States. Gastroenterology. 2015;148:547-555. |
About LG Chem Life Sciences
LG Chem Life Sciences is a business division within LG Chem, engaged in development, manufacturing, and global commercialization of pharmaceutical products. LG Chem Life Sciences seeks to expand and make global presence by focusing on key core therapeutic areas of Immunology, Oncology, and Metabolic Diseases (specifically, diabetes and related metabolic diseases). To achieve such, its strategy is to actively pursue global collaboration encompassing from asset-centric to strategic investment and collaboration.
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