• Results of a Phase 2a dose escalating study of lingdolinurad (ABP-671) for chronic gout, which enrolled patients with mild to moderate renal impairment, showed the URAT1 inhibitor lowered serum uric acid levels below the 6 mg/dL threshold for the disease and was safe and well tolerated.
• Data from a Phase 1 trial of ABP-745, an anti-inflammatory drug for acute gout flares, demonstrated a good safety profile and good pharmacokinetics in healthy volunteers. These findings support Atom’s Phase 2 multi-country study to evaluate ABP-745 as a safer, more effective alternative to colchicine, a standard treatment for acute gout flares.

Atom Therapeutics, a clinical stage biotechnology company developing new treatments for inflammatory and metabolic diseases, announced today it will present two abstracts detailing positive clinical trial data for the company’s two lead drugs, lingdolinurad (ABP-671) for chronic gout and ABP-745 for acute gout flares, at the American College of Rheumatology’s ACR Convergence 2025, October 24 – 29, 2025, in Chicago.

The abstract titled, “A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ABP-671 in Subjects with Hyperuricemia or Gout in China,” will be presented by Ullrich Schwertschlag, M.D., Ph.D., FACP, Atom’s Senior Vice President of Clinical Development, Tuesday, October, 28, in Poster Session C, Hall F (10:30 am - 12:30 pm, Central Daylight Time).

The other abstract, titled “A Phase 1 placebo controlled, single (SAD) and multiple dose escalation (MAD) safety and pharmacokinetic (PK) study of a novel colchicine analogue ABP-745 in healthy volunteers (HV),” also will be presented by Dr. Schwertschlag Tuesday, October 28, in Poster Session C, Hall F (10:30 am – 12:30 pm, Central Daylight Time).

“The positive findings in both of these studies have contributed to successfully advancing our goal of providing meaningful relief to patients worldwide suffering from the damaging effects of chronic gout and the disease’s painful acute gout flares,” said William Dongfang Shi, PhD., Atom Founder and CEO. “Both ABP-671 and ABP-745 have the potential to give gout patients more effective and safer alternatives to existing gout therapies, which have insufficient efficacy and are often associated with serious or even life-threatening adverse effects.”

The Phase 2a trial of ABP-671 enrolled 45 chronic gout patients with mild-to-moderate kidney abnormalities. They were randomized to five oral dose groups receiving 1 mg, 2 mg, 4 mg, 6 mg or 12 mg once daily of ABP-671. Serum uric acid (sUA) was reduced in a dose-dependent manner. All patients experienced reduction in sUA below 6 mg/dL, the therapeutic target for chronic gout, with doses from 2 mg to 12 mg once a day. In addition, 85.7% of subjects reached the target of 5 mg/dL at the lowest dose of 1 mg. Higher doses of ABP-671 reduced sUA levels to below 4mg/dL in many patients. ABP-671 was generally safe and well-tolerated.

Based on these study results, Atom will enroll chronic gout patients with mild to moderate renal impairment in future Phase 3 trials of ABP-671.

A global phase 2b study which was recently completed, demonstrated positive top line results for ABP-671 as compared to allopurinol and placebo treatment. See press release.

The Phase 1 study of ABP-745 in healthy volunteers demonstrated the drug was well-tolerated and exhibited dose proportional pharmacokinetics supporting continued development for treatment of acute gout flares. Atom recently enrolled the first patient in a multicenter Phase 2 acute gout flare trial with sites in the US, China and Australia. The trial will compare ABP-745 with placebo and colchicine, a standard treatment for gout flares. See press release.

About Atom Therapeutics

Atom Therapeutics is a fast-growing innovative drug company focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, ABP-671, is in late-stage clinical development for treatment of chronic gout. Another small molecule ABP-745 has shown significant efficacy and good safety in animal models of inflammation. Phase 2 clinical trials with ABP-745 have been started for the treatment of acute gout. For more information, please visit: https://www.atombp.com or atombp.us.

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