May 21, 2026 — Sobi^® (STO: SOBI) 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.

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.

"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."

Pozdeutinurad was added to Sobi's global development portfolio in February 2026 following its acquisition of Arthrosi, invested by Viva BioInnovator (VBI), 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 enrolled, and data are expected in the second half of 2026.

About the REDUCE 2 study
REDUCE 2 was a pivotal Phase 3, twelve-month, randomised, double-blind, placebo-controlled study. The study included 811 patients globally with a majority being inadequate responders to urate lowering therapies (ULTs). Patients were randomised into one of three groups either receiving pozdeutinurad 50mg, pozdeutinurad 75mg or placebo. The primary efficacy endpoint was proportion of participants whose sUA level is < 6.0 mg/dL at month 6. Secondary endpoints included a reduction in flares and tophi over time, and safety.

About pozdeutinurad
Pozdeutinurad (AR882) is an investigational URAT1 inhibitor being developed for the treatment of patients with gout, including those with uncontrolled gout and tophaceous gout. Phase 2 studies demonstrated compelling efficacy with a sustained reduction of serum uric acid, dissolution of tophi and a well-tolerated safety profile. It is being evaluated in two Phase 3 studies, REDUCE 1 and REDUCE 2, two twelve-month, randomised, double-blind, placebo-controlled studies to assess pozdeutinurad's ability to reduce sUA in gout patients including those with uncontrolled gout and tophaceous disease.

About Sobi^®
Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 2 000 employees across Europe, North America, the Middle East, Asia and Australia. In 2025, revenue amounted to SEK 28 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.