LG Chem Receives FDA Approval for Second NASH Drug Phase 1 Clinical Trial in the US

[Asia Economy Reporter Lee Chun-hee] LG Chem is actively expanding the development of new drugs for non-alcoholic steatohepatitis (NASH), a globally unexplored disease, by simultaneously advancing clinical trials for two NASH drug candidates.

On the 29th (local time), LG Chem announced that it received approval from the U.S. Food and Drug Administration (FDA) for the clinical trial application (IND) of ‘LG203003,’ a NASH drug candidate that selectively inhibits the activity of the triglyceride synthesis enzyme 'DGAT-2' to suppress fat accumulation in the liver.

LG Chem has secured a new mechanism NASH drug candidate following 'LG303174,' an anti-inflammatory mechanism drug currently in phase 1 clinical trials. LG Chem plans to complete the phase 1 trial of LG303174 soon and enter phase 2 clinical trials in the U.S. within this year.

NASH is a disease in which inflammation occurs in liver tissue due to fat accumulation in the liver, unrelated to alcohol consumption. If it progresses, it can worsen to liver cirrhosis and eventually liver cancer. Due to its complex pathogenesis involving fat accumulation, inflammation, and fibrosis, the development of treatments is highly challenging, and no commercialized therapies currently exist.

Through this phase 1 clinical trial, LG Chem plans to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and changes in liver fat content of LG203003 in 88 healthy adults and adults with non-alcoholic fatty liver disease (NAFLD) in the U.S. LG203003 has shown significant improvements in liver triglycerides, inflammation, and fibrosis in prior preclinical studies. Additionally, it is being developed as a once-daily oral medication, which is expected to offer higher medication convenience compared to other DGAT-2 inhibitors.

According to market research data from GlobalData, the global NASH market was approximately 240 billion KRW in 2020, centered on alternative medicines, and is projected to exceed 20 trillion KRW by 2029.

Son Ji-woong, Head of Life Sciences Business Division at LG Chem, stated, “We will continuously secure NASH drug candidates with various mechanisms to enhance complementary synergy,” adding, “Through accelerating global clinical development of promising drug candidates, we aim to maximize the future growth potential of our bio business.”

This content was produced with the assistance of AI translation services.