STOCKHOLM – October 29, 2026 -- Sobi's investigational gout drug pozdeutinurad (AR882) met the primary endpoint of the Phase 3 REDUCE-2 study, with 69.2% of patients on the 75 mg dose reaching serum urate (SU) below 6 mg/dL at month 6, against 8.1% on placebo. The company is presenting the late-breaking data at ACR Convergence 2026.
Both pozdeutinurad doses beat placebo on the primary endpoint at month 6
REDUCE-2 randomised 811 gout patients to pozdeutinurad 75 mg, pozdeutinurad 50 mg or placebo. In the 50 mg arm, 56.6% of patients achieved SU below 6 mg/dL at month 6. Both doses were significant versus placebo (p<0.0001).
Pozdeutinurad is a once-daily oral, highly selective URAT1 inhibitor. Sobi is developing it for uncontrolled gout, defined as SU above 6 mg/dL with persistent flares and/or tophi despite oral urate-lowering therapy.
Urate reductions appeared at month 1 and held through month 12
Clinically meaningful SU reductions were observed as early as month 1 and were sustained through month 12. At every assessment in the 12-month period, more pozdeutinurad-treated patients than placebo patients achieved SU below 6, 5, 4 and 3 mg/dL.
Adverse event rates in the pozdeutinurad arms matched placebo at about 61%
Treatment-emergent adverse events occurred in 60.7% of patients on 75 mg, 61.7% on 50 mg and 60.9% on placebo.
Puja P. Khanna, a University of Michigan rheumatology professor and REDUCE-2 investigator, said many patients remain inadequately controlled on current oral therapies, which can lead to permanent joint and tissue damage.
Sobi runs two 12-month Phase 3 studies covering more than 800 patients
REDUCE-2 is one of two randomised, double-blind, placebo-controlled 12-month Phase 3 trials, alongside REDUCE 1. Phase 2 studies had shown sustained SU reduction, tophi dissolution and a generally well-tolerated safety profile.
Lydia Abad-Franch, Sobi's Head of R&D and Medical Affairs and Chief Medical Officer, pointed to the consistency of results across both doses. She said the company will continue advancing the programme.
Khanna presents abstract LB20 on November 11 in the Chapin Theater
The presentation, titled "Treatment with URAT1 Inhibitor Pozdeutinurad (AR882) in a Phase 3, Double-Blind, Randomized Study Lowers Serum Urate Levels in Participants with Gout", is scheduled for Wednesday, November 11, 2026, 8:15-8:30 AM ET.