Atom Therapeutics Advances Lingdolinurad into China Phase 3 Trial for Gout, Reports Strong Phase 2b Efficacy Data
核心洞察
Atom Therapeutics (搜索) has dosed the first patient in a China Phase 3 trial of lingdolinurad (ABP-671), a novel URAT1 (搜索) inhibitor for chronic gout (搜索), with over 800 patients planned for enrollment.
Phase 2b data showed lingdolinurad achieved serum uric acid below 6 mg/dL in over 91% of patients at 2 mg twice daily, significantly outperforming febuxostat.
Lingdolinurad demonstrated complete tophi resolution in some patients within 6 months and reduced acute gout (搜索) flare incidence by 67% compared to placebo.
Atom Therapeutics (搜索) has dosed the first patient in its China Phase 3 clinical trial of lingdolinurad (ABP-671), a novel URAT1 (搜索) inhibitor being developed for chronic gout (搜索) and hyperuricemia (搜索), the company announced on June 23, 2026. The milestone marks a significant step in the company's synchronized global development strategy, with two additional multi-country Phase 3 trials planned to launch in the United States later this year.
The multicenter, randomized, double-blind, parallel-controlled Phase 2b/3 trial plans to enroll more than 800 gout (搜索) patients in China, directly comparing lingdolinurad with febuxostat to evaluate efficacy and safety. Notably, patients with tophaceous gout will be included to assess lingdolinurad's potential to reduce or eliminate tophi — a clinical challenge that existing therapies have struggled to address.
Phase 2b Results Demonstrate Superior Urate Lowering
The Phase 2b data from the China Phase 2b/3 clinical trial provided compelling evidence of lingdolinurad's potency. After 8 weeks of administration at a dose of 2 mg twice daily — with baseline serum uric acid levels of 9.8 mg/dL (588 μmol/L) — the proportions of subjects achieving serum uric acid below key thresholds were striking: over 91% reached below 6 mg/dL (360 μmol/L, the primary endpoint), 83% fell below 5 mg/dL (300 μmol/L), and 63% achieved levels below 4 mg/dL (240 μmol/L). These results demonstrated significantly superior efficacy compared to febuxostat, all with statistical significance.
"Lingdolinurad is one of Atom Therapeutics (搜索)' core assets. It has demonstrated favorable efficacy and a well-tolerated safety profile," said Dr. William Dongfang Shi, Founder, Chairman and CEO of Atom Therapeutics. "Notably, lingdolinurad has shown strong evidence of reducing and eliminating tophi in the subset tophaceous gout (搜索) patients, and significantly lowering the incidence of acute gout flares in the phase 2b studies — key clinical advantages that remain challenging for existing gout therapies to achieve."
Tophi Resolution and Flare Reduction
Lingdolinurad exhibited outstanding tophi dissolution capability, with complete resolution of tophi observed in some subjects within less than 6 months of treatment. Additionally, a recent clinical trial in the US indicated that within 3-6 months post-administration, the incidence of acute gout (搜索) attacks decreased by 67% compared to the placebo group. In terms of safety, adverse events were predominantly mild to moderate, with no severe adverse events reported.
ABP-745: A Parallel Anti-Inflammatory Program
Atom Therapeutics (搜索) is also advancing ABP-745, a novel anti-inflammatory small molecule that inhibits NLRP3 inflammasome (搜索) assembly and suppresses multiple inflammatory cytokines, including IL-1β, IL-6, IL-18, and TNF-α. The drug has demonstrated a significantly better safety profile than colchicine, with no observed risk of drug-drug interactions.
A global multicenter Phase 2 clinical trial of ABP-745 for acute gout (搜索) flares is ongoing in the US, China, and Australia, nearing completion of patient dosing. The study compares ABP-745 to both placebo and colchicine, with top-line data readout expected in August 2026.
Beyond gout (搜索), ABP-745 is being evaluated for atherosclerotic cardiovascular disease (搜索) (ASCVD). A multi-country Phase 2 trial launched in April 2026, with data readout expected in Q4 2027. Preclinical data showed that ABP-745, when used in combination with atorvastatin in an atherosclerosis mouse model, reduced plaque area by 75%, compared to a 50% reduction with atorvastatin alone. Atom is also planning Phase 2 trials for pericarditis and heart failure.
Addressing a Growing Global Burden
Gout (搜索) is a chronic disease caused by long-term hyperuricemia (搜索), defined as serum uric acid levels above 7 mg/dL (420 μmol/L). The condition can lead to joint deformities and chronic kidney disease, and recurrent gout attacks may increase the risk of sudden death. Current urate-lowering therapies remain limited in availability and are often associated with suboptimal efficacy and significant safety concerns.
Dr. Shi emphasized the scale of unmet need: "We look forward to the timely completion of the Phase 3 clinical program, with the goal of providing more effective, safer, and long-term treatment options for over 60 million gout (搜索) patients and more than 300 million individuals with hyperuricemia (搜索) worldwide."
Lingdolinurad achieves its potent urate-lowering effects by inhibiting renal tubular urate reabsorption and promoting uric acid excretion. The drug is positioned as monotherapy for chronic gout (搜索) patients, as well as in combination with allopurinol for refractory gout. The overseas Phase 3 program, primarily conducted in the US, has been reviewed by the FDA and is planned for initiation in Q4 2026.
Roy J. Wu, MBA, Senior Vice President for Global Business Development at Atom Therapeutics (搜索), will present a corporate update and clinical data at the BIO International Convention 2026 in San Diego, scheduled for June 22 at 4:30 pm in Theater 1 of the BIO Business Forum.