Detailed efficacy and safety results from the pivotal phase 3 study demonstrate statistically significant serum urate reductions through 12 months

Pozdeutinurad is an investigational, once-daily, highly selective URAT1 inhibitor

STOCKHOLM, Oct. 29, 2026 /PRNewswire/ -- Sobi® (STO: SOBI) today announced the presentation of late-breaking data from the pivotal Phase 3 REDUCE-2 study of pozdeutinurad (AR882), an investigational next-generation once-daily oral, highly selective URAT1 inhibitor, at ACR Convergence 2026. The findings demonstrate clinically meaningful and durable reductions in serum urate (SU) levels through 12 months, with significantly more patients achieving target SU levels compared with placebo and a safety profile generally comparable to placebo. REDUCE-2 is part of the Phase 3 clinical programme evaluating pozdeutinurad in patients with uncontrolled gout.

In the global Phase 3 REDUCE-2 study, 811 patients with gout were randomised to receive pozdeutinurad 75 mg, pozdeutinurad 50 mg or placebo. The study met its primary endpoint, with 69.2% and 56.6% of patients receiving pozdeutinurad 75 mg and 50 mg, respectively, achieving SU levels below 6 mg/dL at month 6, compared with 8.1% of patients receiving placebo (both p<0.0001). Clinically meaningful reductions in serum urate were observed as early as month 1 and were sustained through month 12. At each assessment during the 12-month period, a greater proportion of patients treated with pozdeutinurad achieved SU levels below 6, 5, 4 and 3 mg/dL compared with placebo.

The incidence of treatment-emergent adverse events (TEAEs) was similar across treatment groups, occurring in 60.7%, 61.7% and 60.9% of patients receiving pozdeutinurad 75 mg, pozdeutinurad 50 mg and placebo, respectively.

"Achieving and maintaining target serum urate levels is fundamental to effective gout management, yet many patients remain inadequately controlled with currently available oral therapies, which can lead to permanent joint and tissue damage," said Puja P. Khanna, MD, MPH, Professor of Medicine in the Division of Rheumatology at the University of Michigan and investigator in the REDUCE-2 study. "The REDUCE-2 results demonstrated clinically meaningful and durable serum urate lowering over 12 months, with a safety profile comparable to placebo, supporting the potential of pozdeutinurad as a treatment option for patients living with uncontrolled gout."

"The presentation of these late-breaking Phase 3 data for the first time marks an important milestone in our efforts to advance innovation in gout," said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs and Chief Medical Officer at Sobi. "The consistency of the results across both evaluated doses together with the sustained serum urate lowering through 12 months are encouraging as we continue advancing the programme for patients who need additional treatment options."

Presentation details

Title: (LB20) Treatment with URAT1 Inhibitor Pozdeutinurad (AR882) in a Phase 3, Double-Blind, Randomized Study Lowers Serum Urate Levels in Participants with Gout
Presenter: Puja P. Khanna, MD, MPH
Date: Wednesday, November 11, 2026
Time: 8:15 AM - 8:30 AM ET
Location: Chapin Theater

About gout

Gout is the most common form of systemic inflammatory arthritis^[i]. Elevated serum urate (SU) levels can lead to the accumulation of monosodium urate crystals in joints and other tissues, causing flares, joint damage and intense pain^[ii]. Uncontrolled gout is a systemic, progressive disease characterised by SU levels above 6 mg/dL and persistent, debilitating clinical manifestations, including flares and/or tophi, despite treatment with oral urate-lowering therapies^[iii]^,^[iv]. Elevated SU levels have also been associated with cardiovascular, renal and metabolic diseases. Sustained serum urate (SU) lowering is central to gout management, promoting dissolution of monosodium urate crystals, limiting further crystal deposition, and reducing gout symptoms.

About pozdeutinurad

Pozdeutinurad (AR882) is an investigational once daily oral, highly selective URAT1 inhibitor being developed to treat uncontrolled gout. Phase 2 studies demonstrated clinically significant efficacy with a sustained reduction of serum urate (SU) levels, dissolution of tophi and a generally well-tolerated safety profile. Pozdeutinurad is being evaluated in more than 800 patients, in two 12-month, randomised, double-blind, placebo-controlled Phase 3 studies, REDUCE 1 and REDUCE 2, assessing its ability to reduce SU in patients with uncontrolled gout.

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.

Contacts
For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

^[i] FitzGerald JD. Gout. Annals of Internal Medicine. 2025;178(3):ITC33-ITC48. doi:10.7326/ANNALS-24-03951.
^[ii] Mayo Clinic. Gout - Symptoms and causes. Available at: https://www.mayoclinic.org/diseases-conditions/gout/symptoms-causes/syc-20372897.
^[iii] Chen-Xu M, et al. Arthritis Rheumatol. 2019;71(6):991-999.
^[iv] McAdams MA, et al. J Rheumatol. 2011;38(1):135-141.

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