LG Chem Receives FDA Approval for Phase 1 Clinical Trial Plan of New Diabetes Treatment Drug

LG Chem CI (Photo by LG Chem)

[Asia Economy Reporter Chunhee Lee] LG Chem's new diabetes treatment drug 'LC542019' has received approval for its Phase 1 clinical trial plan (IND) from the U.S. Food and Drug Administration (FDA).

On the 19th, LG Chem announced that it had obtained FDA approval for the Phase 1 IND of LC542019, a new drug candidate for type 2 diabetes that improves insulin resistance. This Phase 1 approval of LC542019 is significant as it marks the acquisition of a total of 10 clinical development pipeline projects within five years since the launch of the Life Sciences Business Division, including the gout treatment drug 'Tigulixostat.'

LG Chem plans to conduct evaluations of the safety, tolerability, pharmacokinetics (absorption, distribution, metabolism, and excretion of the drug), and pharmacodynamics (drug concentration and therapeutic effect) of LC542019 in 98 healthy adults and patients with type 2 diabetes in the United States.

LC542019 works by activating the action of 'GPR120,' a protein that regulates insulin sensitivity, thereby improving insulin resistance. Insulin helps move glucose in the blood into cells to be used as an energy source or stored within the cells. However, when cellular insulin resistance increases, even if insulin is secreted, the transfer of glucose between the blood and cells does not occur normally, resulting in a hyperglycemic state.

LG Chem aims to develop a differentiated diabetes treatment drug that not only reduces blood sugar by improving insulin resistance but also has additional benefits such as weight loss and improvement of fatty liver. Preclinical results of LC542019 confirmed additional effects such as weight loss along with blood sugar improvement. According to market research data from GlobalData, the global market for type 2 diabetes treatments is expected to grow steadily from $56.5 billion (approximately 67 trillion KRW) last year to $91.9 billion (approximately 110 trillion KRW) by 2029.

Son Ji-woong, head of the Life Sciences Business Division, said, “Based on our R&D expertise in diabetes, we will develop innovative new drugs differentiated from existing diabetes medications,” adding, “We will maximize the growth potential of the Life Sciences Business Division by accelerating global clinical development in strategic disease areas and continuously discovering clinical development projects.”