Atom Therapeutics' Gout Drug Shows Promise in Phase 2b/3 Trial

Atom Therapeutics, a Chinese biotech company, has announced positive results from a phase 2b/3 study of its oral URAT1 inhibitor, lingdolinurad (ABP-671), for the treatment of gout. The trial, conducted across multiple continents, met all primary and secondary endpoints, positioning the drug as a potential best-in-class therapeutic in the gout treatment landscape.

Efficacy and Safety Profile

The study evaluated lingdolinurad against both placebo and the approved gout drug allopurinol. Key findings include:

• A significant reduction in the relative risk of acute gout attacks, with a maximum risk reduction of 42% within 15-28 weeks compared to allopurinol and placebo.
• Higher proportion of patients achieving serum uric acid levels below 6 mg/dL and 4 mg/dL compared to allopurinol.
• 91% response rate in reducing tophus diameter by week 28.
• No observed cardiovascular risks or liver toxicity, unlike some existing urate-lowering gout drugs.

William Dongfang Shi, Ph.D., CEO of Atom Therapeutics, stated, "The six-month global phase 2b/3 clinical trial provided compelling evidence that ABP-671 is associated with clinically meaningful improvement in reducing the risk of acute gout attacks and promoting tophus dissolution."

Competitive Landscape

The positive results for lingdolinurad come at a time when the gout treatment market is seeing mixed performance:

• Horizon Therapeutics' Krystexxa, now part of Amgen's portfolio following a $27.8 billion acquisition, has underperformed expectations with $236 million in sales for Q1 2025, falling $57 million short of analyst projections.
• Lingdolinurad's efficacy in lowering serum uric acid levels below 4-5 mg/dL aligns with emerging clinical consensus guidelines, potentially giving it an edge over competitors.

As Atom Therapeutics prepares for pivotal clinical studies, the pharmaceutical industry will be watching closely to see if lingdolinurad can maintain its promising efficacy and safety profile in larger trials and potentially reshape the gout treatment landscape.