LG Chem Completes Phase 2 US Clinical Trial for Gout New Drug: "Efficacy Evaluation Met"

Acceleration Toward Achieving Global Commercialization Goal by 2027

Researchers from LG Chem Life Sciences Division are conducting new drug research activities. (Photo by LG Chem)

[Asia Economy Reporter Jihee Kim] LG Chem announced on the 1st that it has successfully completed Phase 2 clinical trials in the United States for the gout drug ‘LC350189.’ Based on these clinical results, the company plans to accelerate the development of the new drug with the goal of global commercialization by 2027.

According to LG Chem, LC350189 met both the primary and secondary efficacy endpoints at high levels in the US Phase 2 clinical trial. LG Chem received approval from the US Food and Drug Administration (FDA) in June 2019 to conduct Phase 2 clinical trials for the gout drug and has been conducting trials at 45 institutions in the US involving 156 gout patients with serum uric acid levels between 8 mg/dL and 12 mg/dL. LC350189 is an oral gout treatment that inhibits the expression of the enzyme xanthine oxidase (XO), which produces uric acid, the main cause of gout, thereby preventing excessive uric acid production. LG Chem divided the trial into four groups: LC350189 50 mg, 100 mg, 200 mg, placebo, and an exploratory active control group receiving febuxostat, conducting the study over three months.

First, for the primary endpoint, the rate of achieving serum uric acid levels below 5 mg/dL at three months of administration was 62% in the LC350189 200 mg group, compared to 3% in the placebo group and 23% in the febuxostat group. The achievement rates in the low-dose groups of 50 mg and 100 mg were also high at 47% and 45%, respectively. For the secondary endpoint, the rate of achieving serum uric acid levels below 6 mg/dL at three months was 78%, 63%, and 59% in the 200 mg, 100 mg, and 50 mg groups, respectively, while the placebo group recorded 3%. The febuxostat group showed a 54% achievement rate.

Additionally, a rapid onset of efficacy was confirmed within two weeks of administration. In terms of side effects, LC350189 demonstrated safety and tolerability comparable to the placebo group.

Son Ji-woong, Head of the Life Sciences Business Division, said, “Based on the potential of LC350189 confirmed through this Phase 2 clinical trial, we will do our best to provide better treatment options to gout patients worldwide. We will actively pursue global clinical development of multiple pipelines, including the gout drug, obesity treatments, and immuno-oncology agents, to demonstrate differentiated research and development (R&D) capabilities.”

Meanwhile, according to the global market research firm Coherent Market Insights, the global gout treatment market is expected to grow at an average annual rate of 6.7%, expanding from $2.6 billion (approximately 3 trillion KRW) in 2019 to $4.3 billion (approximately 5 trillion KRW) by 2027.

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