Atom Therapeutics, an innovative clinical-stage biotechnology company focused on the discovery and development of novel therapies for metabolic, inflammatory, and cardiovascular diseases, today announced that the first patient has been successfully dosed in its Phase 2 clinical trial evaluating lingdolinurad (ABP-671), for treatment of chronic kidney disease (CKD) with hyperuricemia. This Phase 2 clinical trial is being conducted in Australia and China.

Hyperuricemia is an established independent risk factor for CKD. The studies indicate that for every 1 mg/dL increase in serum uric acid (sUA), the relative risk of developing CKD rises by 49%. Deposition of monosodium urate (MSU) crystals within the renal interstitium can trigger microvascular disease, uric acid nephrolithiasis, and interstitial fibrosis, accelerating the decline of renal function and fueling a vicious pathological cycle. Currently available urate-lowering therapies (ULT) for CKD with hyperuricemia patients face substantial clinical bottlenecks. According to Frost & Sullivan data, 36.6% to 50.0% of CKD patients in China suffer from comorbid hyperuricemia, with an even higher proportion observed in patients at advanced disease stages. Globally, the number of patients of CKD with hyperuricemia reached 435 million in 2025.

Dr. William Dongfang Shi, CEO, Chairman, and Founder of Atom Therapeutics, commented, “There is a close bidirectional pathological causal relationship between hyperuricemia and CKD. The successful dosing of the first patient in this Phase 2 trial is a pivotal milestone for Atom. We look forward to providing safe and effective innovative treatment options for CKD patients with hyperuricemia.”

Preclinical findings in animal models of CKD by hyperuricemia demonstrated that lingdolinurad not only significantly lowered sUA and blood urea nitrogen (BUN), but also substantially improved serum creatinine levels at higher doses. In clinical trials involving subjects with normal renal function, mild CKD, or moderate CKD, lingdolinurad has shown favorable safety and tolerability profiles. In a Phase 2b study for gout in China, lingdolinurad (2 mg BID) achieved remarkable urate-lowering efficacy: at the 8-week treatment endpoint, the proportions of patients achieving sUA < 6.0 mg/dL, sUA < 5.0 mg/dL, and sUA < 4.0 mg/dL reached 91.9%, 83.5%, and 63.5%, respectively. Furthermore, lingdolinurad showed robust tophi dissolution and reduction in frequency of acute gout flares.

About Atom Therapeutics

Atom Therapeutics is an innovative, clinical-stage biotechnology company focused on the discovery and development of novel therapies for metabolic, inflammatory, and cardiovascular diseases. The company’s lead product, lingdolinurad (ABP-671), is a highly potent and selective oral URAT1 inhibitor currently undergoing pivotal Phase 3 trials in China and globally for treatment of chronic gout, hyperuricemia, tophaceous gout, and refractory gout. Lingdolinurad is also currently in phase 2 study for CKD patients with hyperuricemia. Another compound ABP-745, targeting multiple pathways involved in inflammation, foam cell formation, myocardial remodeling and fibrosis, has demonstrated favorable pharmacokinetics and safety in Phase 1 trials and is under phase 2 trials for treatment of acute gout flares and atherosclerotic cardiovascular disease. The phase 2 INDs for heart failure and pericarditis are currently under preparation. Atom Therapeutics is committed to deliver safer, more effective, and transformative medicines to patients worldwide. For more information, please visit www.atomthera.com or atomthera.us

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