Pozdeutinurad (AR882) is a next-generation, highly selective URAT1 inhibitor taken orally once daily. In the global REDUCE-2 study, 811 patients with gout were randomized to receive pozdeutinurad 75 mg, pozdeutinurad 50 mg, or placebo.

The study met its primary endpoint. At month 6, 69.2% of patients on the 75 mg dose and 56.6% of patients on the 50 mg dose reached serum uric acid levels below 6 mg/dL, compared with 8.1% of patients on placebo (both p<0.0001). Clinically meaningful reductions were seen as early as month 1 and were maintained through month 12. At every measurement point, a larger share of patients on pozdeutinurad reached levels below 6, 5, 4, and 3 mg/dL than patients on placebo.

The Stockholm-based company reports that the safety profile was generally comparable to placebo. Treatment-emergent adverse events were reported in 60.7% of patients on the 75 mg dose, 61.7% on the 50 mg dose, and 60.9% on placebo.

“Reaching and maintaining target serum uric acid levels is fundamental to effective gout treatment. Yet many patients don’t achieve adequate disease control with current oral therapies, which can lead to lasting joint and tissue damage,” says Puja P. Khanna, MD, MPH, Professor of Medicine in the Division of Rheumatology at the University of Michigan and an investigator in REDUCE-2. “The REDUCE-2 results show a clinically meaningful reduction in serum uric acid that was sustained over 12 months, with a safety profile comparable to placebo, which strengthens the potential of pozdeutinurad as a treatment option for patients with uncontrolled gout.”

“Presenting these Phase III data for the first time in a late-breaking session is an important milestone in our work to drive innovation in gout treatment,” says Lydia Abad-Franch, MD, Head of R&D, Medical Affairs, and Chief Medical Officer at Sobi. “The consistent results across both doses, and the reduction in serum uric acid sustained through month 12, are encouraging as we continue to develop the program for patients who need more treatment options.”

REDUCE-2 is part of the Phase III program evaluating pozdeutinurad in patients with uncontrolled gout.