Atom Therapeutics has announced enrollment of the first patient in a Phase II trial (NCT07145229) for ABP-745, a novel anti-inflammatory drug targeting acute gout flares.

According to the company, ABP-745 is designed to provide effective relief from the intense pain and swelling associated with acute flares while minimizing the safety concerns linked to existing treatments. Further, the drug may have potential applications in other inflammatory conditions due to its potential for the broad inhibition of key inflammatory mediators.¹

What Potential Impact Could ABP-745 Have on the Treatment of Acute Gout Flares?

“This study follows a Phase I trial in the US demonstrating that ABP-745 is safe and well tolerated and represents significant progress in our development of a new anti-inflammatory drug,” said William Dongfang Shi, founder, chairman, CEO, Atom Therapeutics, in a press release. “ABP-745 was designed as a new chemical entity with the intention of improving efficacy without the concern for key interactions with other medications and better safety than colchicine in the treatment of acute gout flares.”

Phase II Trial Design

• The randomized, double-blind, multicenter trial will enroll over 200 patients across the United States, China, and Australia. Invesigators will evaluate the safety, efficacy, and pharmacodynamics of ABP-745 in reducing pain and swelling during acute gout flares, with patients receiving either ABP-745, placebo, or standard colchicine treatment for comparison.
• All enrolled patients will be required to have experienced two or more gout flares within 12 months prior to screening.
• Patients receiving urate-lowering therapies will be required to be on stable doses of these drugs prior to first dose of study treatment.
• The primary endpoint of the trial is change in visual analog scale (VAS) pain score of the target joint.
• Key secondary endpoints include change and percentage change from baseline in VAS pain score of the target joint and incidence of treatment-emergent adverse events.^1,2

Atom’s Chronic Gout Therapy Achieves Key Clinical Milestone

Atom’s current drug pipeline has shown promising clinical results for the treatment of gout. Last week, Atom announced that its global Phase IIb/III trial of lingdolinurad (ABP-671), an oral URAT1 inhibitor for chronic gout, successfully met its primary endpoint, showing significant reductions in serum uric acid levels along with strong safety and tolerability.

According to Atom, the treatment reduced the risk of acute gout attacks by up to 42% between weeks 15 and 28. The drug demonstrated rapid and meaningful tophus dissolution, with a 91% response rate in reducing tophus diameter by week 28.³

Gout Prevalence and Burden

• Gout, which is caused by hyperuricemia, is one of the most prevalent forms of inflammatory arthritis, impacting over 60 million people globally.
• Notably, it affects a significant number of people across the United States, Europe, Asia, and Latin America.
• In the United States alone, roughly 12 million people are currently living with gout, experiencing an average of 6.6 acute flares each year.
• Because many flares go unreported, the actual burden is likely greater, with the total number of acute gout flares in the United States potentially surpassing 80 million annually.¹

Broader Implications of ABP-745

“While the first clinical indication for ABP-745 is for the treatment of acute gout flares, based on its positive inhibitory effects on various inflammatory factors such as IL-1β, TNF-α, IL-6, and IL-18, it will also be developed for other inflammatory conditions including certain types of cardiovascular disease,” concluded Shi, in the press release.

References

1. Atom Therapeutics Enrolls First Patient in Multicenter Global Phase 2 Trial of ABP-745 for Acute Gout Flares. Business Wire. September 15, 2025. Accessed September 15, 2025. https://www.businesswire.com/news/home/20250915080338/en/Atom-Therapeutics-Enrolls-First-Patient-in-Multicenter-Global-Phase-2-Trial-of-ABP-745-for-Acute-Gout-Flares
2. Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare. Clinicaltrials.gov. Accessed September 15, 2025. https://clinicaltrials.gov/study/NCT07145229
3. Atom Therapeutics Announces Positive Topline Results of Lingdolinurad (ABP-671) in Phase 2b/3 Trial for Chronic Gout. Atom. September 8, 2025. Accessed September 15, 2025. https://atomthera.us/2025/09/07/atom-announces-positive-topline-results-of-lingdolinurad-in-phase-2b-3-trial-for-gout/