LC350189 showed significant serum uric acid (sUA)-lowering effects across all dose levels.
LC350189 was shown to be well-tolerated.

SEOUL, SOUTH KOREA & CAMBRIDGE, MASS-- July 02, 2021 -- LG Chem announced topline results for the phase 2 study evaluating the efficacy and safety profiles of LC350189, a novel non-purine xanthine oxidase inhibitor for the chronic management of hyperuricemia in patients with gout disease.

LG Chem had received FDA clearance to commence a Phase 2 trial of LC350189 in June 2019 and conducted the Phase 2 study (CLUE study, NCT03934099) with 156 gout patients at 45 clinical sites in the US.

Participants with chronic gout, defined as hyperuricemia and a history or presence of gout according to ACR criteria and baseline sUA levels ≥ 8 mg/dL, ≤12 mg/dL were administered LC350189 (50, 100, and 200 mg) or placebo orally, once daily for 3 months, with a subset of 13 out of 156 participants enrolled in a febuxostat, 40mg - 80 mg QD, active control group.

During the study period, colchicine 0.6 mg (QD) was prescribed for prophylaxis of gout flares. The primary endpoint was the response rate achieving sUA < 5 mg/dL at month 3.

Topline results from the CLUE study are as follows:

· The proportion of gout patients reaching sUA < 5 mg/dL at month 3 by study arms was 47% (16/34) at 50 mg, 45% (17/38) at 100 mg, 62% (23/37) at 200 mg LC350189, respectively, 23% (3/13) with Febuxostat and 3% (1/34) with placebo.
· The proportion of patients achieving sUA < 6 mg/dL at month 3 as the secondary endpoint was 59%, 63%, 78% at 50, 100, and 200 mg of LC350189, respectively, 54% in the Febuxostat group, and 3% in the placebo group.
· LC350189 showed good dose-dependent reduction in sUA levels lowering rapidly within 2 weeks, and sUA levels were well maintained throughout the study period.
· LC350189 was well tolerated in gout patients at all dose levels compared to the placebo group. There was no notable difference in the overall incidence of TEAE (treatment-emergent adverse events) between the active and placebo groups.

“Many gout patients could benefit from medicines with improved efficacy and safety profiles from the current standard of care. As LC350189 demonstrated in the CLUE study, we can be confident that LC350189 will be a better treatment option for gout patients in the near future,” said Dr. Jeewoong Son, President of LG Chem Life Sciences in Seoul, Korea.