Atom Therapeutics to Present Phase 2b/3 Data Showing Superior Efficacy of Lingdolinurad (ABP-671), Compared to Febuxostat, for Patients with Chronic Gout and Hyperuricemia at ACR Convergence 2026

• Lingdolinurad, a novel oral URAT1 inhibitor, achieved its primary endpoint in lowering serum uric acid (sUA) to < 6 mg/dL and a secondary endpoint in dissolution of tophi, an indicator of advanced gout, while also demonstrating a favorable safety and tolerability profile.
• The China Phase 2b/3 trial results revealed lingdolinurad achieved statistically significant and clinically meaningful improvements for chronic gout patients compared to febuxostat, an oral xanthine oxidase inhibitor and commonly used medication that has been associated with severe adverse side effects.
• In addition, data showed the proportion of patients achieving sUA < 6mg/dL after 8 weeks of treatment with 2 mg lingdolinurad twice daily was 91.9% compared to 51.6% for patients receiving 40 mg of febuxostat once daily.
• Millions of people worldwide suffer from chronic gout and the numbers of patients are rising especially in the US, China and Europe. Current market therapies offer limited effectiveness.

HANGZHOU, China & NEWARK, Calif.--(BUSINESS WIRE)--Atom Therapeutics, a clinical stage biotechnology company developing new treatments for inflammatory and metabolic diseases, announced today Phase 2b/3 trial results showing lingdolinurad significantly outperformed febuxostat in treating chronic gout and hyperuricemia in Chinese patients will be presented at the American College of Rheumatology’s ACR Convergence 2026, November 6 – 11, in Orlando, FL. The data also confirm lingdolinurad achieved its primary and secondary endpoints in lowering serum uric acid (sUA) and dissolving tophi, an indicator of advanced chronic gout.

The abstract titled “A Multicenter, Randomized, Double-Blind, Placebo/Febuxostat-Controlled, Phase 2b/3 Study to Assess the Efficacy and Safety of ABP-671 in Participants With Gout and Hyperuricemia: Results from the 24-Week Extension Period of the Phase 2b Study” will be presented by Zhuoli Zhang, MD, of Peking University Hospital in Beijing, China, on Monday, November 9, 10:30 am to 12:30 pm US Eastern Time in Poster Session B (Metabolic & Crystal Arthopathies – Basic & Clinical Science).

William Dongfang Shi, PhD., Atom CEO, Chairman and Founder, said, “The results from this Phase 2b portion of our Phase 2b/3 trials not only reveal lingdolinurad’s superior efficacy over febuxostat, but also establish lingdolinurad’s favorable safety profile, optimum dose and remarkable effectiveness in lowering sUA levels and reduction or resolution of gout tophi. A Phase 3 trial in China is ongoing and data readout is expected in Q3/2027 followed by a China NDA submission in early 2028.”

Additionally, Atom’s three global Phase 3 studies will evaluate lingdolinurad as a monotherapy for chronic gout, as an add-on study in refractory gout, and as an add-on treatment for tophaceous gout.

Chronic gout, a growing global crisis, is caused by persistent hyperuricemia (sUA >7 mg/dL) that leads to the deposition of monosodium urate (MSU) crystals, triggering pain inflammation and tissue damage in joints, synovium, tendons, and kidneys. If hyperuricemia is inadequately controlled, accumulation of urate crystals can lead to tophaceous gout, the most severe form of chronic gout. Tophi can cause bone erosion, synovial thickening, joint deformity, and, in severe cases, loss of joint function and impaired renal function.

The China Phase 2b study results showed that after 8 weeks administering 2 mg lingdolinurad twice daily (with patients whose baseline mean sUA levels were 9.8 mg/dL), the proportions of those patients achieving sUA levels below 6 mg/dL, 5 mg/dL and 4 mg/dL exceeded 91%, 83%, and 63%, respectively, successfully obtaining the trial’s primary endpoint and showing significantly superior efficacy compared to febuxostat.

After 8 weeks, all patients received 2 mg lingdolinurad twice daily for 24 weeks to assess the impact of dissolving tophi as a secondary endpoint of the trial. Results demonstrated lingdolinurad exhibited outstanding tophi dissolution and reduction capability, with complete resolution of tophi in some subjects.

The data also demonstrated a favorable overall safety and tolerability profile for lingdolinurad throughout the study’s treatment period, consistent with the data from completed global studies.

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 in a 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 in Phase 2 trials for treatment of acute gout flares and atherosclerotic cardiovascular disease. A pre-IND of Phase 2 for ABP-745 for treatment of heart failure with preserved ejection fraction was submitted to FDA in October 2026. ABP-745 is also planned for Phase 2 IND for recurrent pericarditis. For more information, visit www.atomthera.com or atomthera.us