SEOUL, South Korea & CAMBRIDGE, Mass--(BUSINESS WIRE)--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.
LC350189 is a novel xanthine oxidase inhibitor targeting the reduction of uric acid in the final product in purine metabolism, by inhibiting the activity of xanthine oxidase. It has a different structure from other xanthine oxidase inhibitors such as the purine analog xanthine oxidase inhibitor, allopurinol. LC350189 is under development as a 1st line treatment in the U.S. and has demonstrated sufficient efficacy for sUA lowering and a good safety profile in a Phase 2 study.
Gout is a disorder that manifests as a spectrum of clinical and pathologic features built on a foundation of an excess body burden of uric acid, manifested in part by hyperuricemia, which is variably defined as a serum urate level greater than either 6.8 or 7.0mg/dL. Tissue deposition of monosodium urate monohydrate crystals in supersaturated extracellular fluids of the joint, and certain other sites, mediates most of the clinical and pathologic features of gout. Typically, the disease initially presents as acute episodic arthritis. Gout also can manifest as chronic arthritis of one or more joints. Diagnosis of chronic gout should be considered in patients when more that 4 of following criteria are met: 1. attack of acute arthritis, 2. mono or oligoarthritis attacks, 3. rapid onset of pain and swelling, 4. podagra, 5. erythema, 6. unilateral tarsitis, 7. possible tophi, and/or 8. Hyperuricemia
- Khanna D, et al. 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1431-46.
- Peláez-Ballestas I, et al. Diagnosis of chronic gout: evaluating the American college of rheumatology proposal, European league against rheumatism recommendations, and clinical judgment. J Rheumatol. 2010 Aug 1;37(8):1743-8.
About LG Chem Life Sciences:
LG Chem Life Sciences is a business division within LG Chem, engaged in the development, manufacturing, as well as commercializing pharmaceutical products globally. LG Chem Life Sciences seeks to expand and make a 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 asset-centric global collaborations including strategic investments.