A groundbreaking study has revealed promising results for individuals battling hyperuricemia and gout, offering a glimmer of hope in their quest for effective treatment. The study, presented at the American College of Rheumatology Convergence 2025, focused on Lingdolinurad (ABP-671), a potential game-changer in managing these conditions.
Led by Dr. Ullrich Schwertschlag, Atom's Senior Vice President of Clinical Development, the research enrolled adults up to 55 years old with asymptomatic hyperuricemia or gout. The participants were carefully selected, ensuring no clinically significant kidney abnormalities. They were then randomized into groups, receiving either Lingdolinurad or a placebo, with doses ranging from 1 to 12 mg.
One of the key findings was the excellent safety profile of Lingdolinurad. Treatment-emergent adverse events were reported in a minority of participants, and importantly, these events were not dose-dependent. This means that even at higher doses, the drug was well-tolerated, a crucial factor in long-term treatment.
But here's where it gets interesting: the study also demonstrated a clear dose-dependent reduction in serum uric acid (sUA) levels. The higher the dose, the more significant the decrease in sUA, with the maximum median decreases occurring between 3 and 9 hours post-dose. For instance, in participants with gout, the maximum mean sUA decrease from baseline was a remarkable 79.2% with the 12 mg dose.
And this is the part most people miss: the study also showed that the proportion of participants reaching specific sUA thresholds increased consistently with the dose. For example, in the 12 mg group, 100% of participants achieved an sUA level below 4.0 mg/dL, a significant milestone in managing these conditions.
Atom, the company behind Lingdolinurad, also presented data on another novel drug, ABP-745, a colchicine analogue. This drug, too, showed promising results in terms of safety and pharmacokinetics.
Dr. William Dongfang Shi, Founder and CEO of Atom, emphasized the significance of these findings, stating that they bring us closer to providing meaningful relief to gout patients worldwide. With existing therapies often falling short and associated with severe adverse effects, these new drugs offer a safer and more effective alternative.
The study's success has paved the way for further clinical trials, bringing hope to those suffering from the painful and damaging effects of chronic gout and acute gout flares.