Atom Therapeutics is touting data from a phase 2b/3 study as evidence that its gout drug has the efficacy and safety profile to stand out from the competition.
The Chinese biotech evaluated the oral URAT1 inhibitor, called lingdolinurad, against placebo or the approved gout drug allopurinol in a trial conducted across the U.S., Europe, Latin America and Australia. The study met all primary and secondary endpoints, Atom explained in a Sept. 8 release.
When compared to the allopurinol and placebo cohorts, patients who received ABP-671 experienced a significant reduction in the relative risk of acute gout attacks, with “a maximum risk reduction of 42% within the period of 15-28 weeks,” Atom said.
Not only did the study show that patients receiving ABP-671 were more likely to see their serum uric acid levels fall below 6 mg/dL than those on allopurinol, but a higher proportion of the ABP-671 cohort also saw their levels fall below 4 mg/dL.
Atom said that an “increasing number of clinical consensus guidelines” now support maintaining uric acid levels at around 4-5 mg/dL, below the 6-mg/dL threshold recommended by the American College of Rheumatology for reducing gout flares and long-term joint damage.
Gout can result in small lumps of urate crystals called tophi developing under the skin. Atom said ABP-671 demonstrated “good efficacy” at dissolving tophi over six months of treatment, with a “remarkable reduction in gouty stone compared to baseline levels.”
The response rate of a reduction in tophus diameter by Week 28 reached 91%, the company added.
Unlike some approved urate-lowering gout drugs like febuxostat and benzbromarone, the trial didn’t link ABP-671 to any cardiovascular risks or liver toxicity, Atom stressed.
In a statement, Atom CEO William Dongfang Shi, Ph.D., said the combined efficacy and safety data from the study position ABP-671 as a “leading candidate for best-in-class therapeutic in this area.”
“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,” he added. “These findings lay the groundwork for the design and planning of our upcoming pivotal clinical studies.”
A relatively recent addition to the gout treatment arsenal was Horizon Therapeutics’ Krystexxa, which Amgen took on through its $27.8 billion acquisition of the drugmaker two years ago. However, Krystexxa hasn’t performed quite as well as expected, with $236 million of sales in the first quarter of 2025 falling $57 million shy of analyst expectations.