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Positive topline results from the pivotal Phase 3 REDUCE 2 study of pozdeutinurad in gout

Sobi® (STO: SOBI) today announced positive topline results from the pivotal Phase 3 REDUCE 2 study (NCT06439602) evaluating pozdeutinurad (AR882), an investigational next-generation once-daily oral selective URAT1 inhibitor, in adults with gout including those with uncontrolled gout (also referred to as progressive gout) and inadequately controlled by existing therapies.

articleSwedish Orphan Biovitrum AbMay 21, 20264/company/swedish-orphan-biovitrum-ab/news/positive-topline-results-from-the-pivotal-phase-3-reduce-2-study-of-pozdeutinurad-in-gout
Positive topline results from the pivotal Phase 3 REDUCE 2 study of pozdeutinurad in gout

About this update from Swedish Orphan Biovitrum Ab

[{"type":"text","content":"Both doses of once-daily pozdeutinurad (AR882) met the primary efficacy endpoint of sUA reduction at month 6 vs placebo ","length":119,"tagName":"p"},{"type":"text","content":"Pozdeutinurad was overall well tolerated, and the safety profile was consistent with previous studies","length":101,"tagName":"p"},{"type":"text","content":"STOCKHOLM, May 21, 2026 /PRNewswire/ -- Sobi® (STO: SOBI) today announced positive topline results from the pivotal Phase 3 REDUCE 2 study (NCT06439602) evaluating pozdeutinurad (AR882), an investigational next-generation once-daily oral selective URAT1 inhibitor, in adults with gout including those with uncontrolled gout (also referred to as progressive gout) and inadequately controlled by existing therapies.","length":413,"tagName":"p"},{"type":"text","content":"Both doses of pozdeutinurad met the primary efficacy endpoint, defined as the proportion of patients achieving a serum uric acid (sUA) level <6 mg/dL at month 6 (75 mg: 69.2% vs 8.1%; p<0.0001; 50 mg: 56.6% vs 8.1%; p<0.0001). The safety profile was consistent with previous studies. Detailed results are expected to be presented at a forthcoming scientific congress in Q4.","length":382,"tagName":"p"},{"type":"text","content":""We are very encouraged by these results and their implications for patients whose gout remains inadequately controlled," said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs and Chief Medical Officer at Sobi. "These findings, including sustained urate lowering and a favourable efficacy and tolerability profile, support the potential of pozdeutinurad to address a significant unmet need and provide a strong foundation for regulatory submissions."","length":480,"tagName":"p"},{"type":"text","content":"Pozdeutinurad was added to Sobi's global development portfolio in February 2026 following its acquisition of Arthrosi, Inc., a biotechnology company focused on developing treatments for gout, and further enhances Sobi's presence in this area. Pozdeutinurad is being investigated in two global Phase 3 studies, REDUCE 1 and REDUCE 2 which are 12-month, randomised, double-blind, placebo-controlled trials designed to evaluate pozdeutinurad in patients with gout, including those with tophaceous gout. REDUCE 1 and REDUCE 2 enrolled more than 800 patients each. REDUCE 1 is fully enr...

More updates from Swedish Orphan Biovitrum Ab

topline resultsgoutPhase 3 studiessafety profileSobipatientsserum uric acid