Sobi reports Phase 3 REDUCE-2 results for pozdeutinurad, with both doses significantly reducing serum urate levels through 12 months in patients with gout.
Written By: Anamika Koshti, PharmD
Reviewed By: Pharmacally Editorial Team
Sobi announced on October 29, 2026, that detailed results from the Phase 3 REDUCE-2 study (NCT06439602) evaluating pozdeutinurad (AR882) will be presented as a late-breaking abstract at ACR Convergence 2026. The investigational once-daily oral, highly selective urate transporter 1 (URAT1) inhibitor demonstrated statistically significant serum urate (SU) reductions sustained through 12 months in patients with gout. The company also reported a treatment-emergent adverse event profile generally comparable to placebo.
REDUCE-2 Evaluated Two Doses in 811 Patients with Gout
REDUCE-2 was a global, randomized, double-blind, placebo-controlled Phase 3 study involving 811 patients with gout. Participants received once-daily pozdeutinurad 75 mg, pozdeutinurad 50 mg or placebo over a 12-month treatment period. A majority of participants were inadequate responders to existing urate-lowering therapies (ULTs).
The primary endpoint was the proportion of patients achieving SU below 6 mg/dL at month 6. Secondary endpoints included reductions in gout flares and tophus burden over time, alongside safety assessments.
The study forms part of Sobi’s Phase 3 development programme targeting patients with uncontrolled gout, including those who continue to experience flares or tophi despite oral ULT.
Both Doses Met the Primary Endpoint, With Sustained Urate Reduction
At month 6, 69.2% of patients receiving pozdeutinurad 75 mg and 56.6% receiving 50 mg achieved SU below 6 mg/dL, compared with 8.1% in the placebo group. Both treatment comparisons were statistically significant (p<0.0001).
Sobi reported that clinically meaningful SU reductions emerged as early as month 1 and remained sustained through month 12. At every assessment during the 12-month period, a greater proportion of pozdeutinurad-treated patients achieved SU levels below 6, 5, 4 and 3 mg/dL compared with placebo.
Although the 75 mg dose produced a numerically higher response rate than the 50 mg dose, the announcement did not report a formal statistical comparison between the two doses.
Importantly, the October announcement did not disclose numerical month-12 response rates or results for the secondary endpoints involving gout flares and tophus burden.
Overall Adverse Event Rates Were Similar Across Groups
Treatment-emergent adverse events (TEAEs) occurred in 60.7% of patients receiving pozdeutinurad 75 mg, 61.7% receiving 50 mg and 60.9% receiving placebo.
While these figures indicate similar overall TEAE incidence across the treatment groups, the announcement does not provide detailed breakdowns of serious adverse events, treatment discontinuations or renal and hepatic safety findings. These data will be important for a more complete assessment of the drug’s safety profile.
Sobi Advances an Acquired Gout Asset Through Phase 3 Development
Pozdeutinurad entered Sobi’s global development portfolio in February 2026 following the company’s acquisition of Arthrosi, a biotechnology company focused on gout treatments. The REDUCE-2 results represent an important clinical development milestone for the acquired asset, providing Phase 3 evidence of sustained serum urate reduction in a population largely inadequately controlled with existing therapies.
The companion Phase 3 REDUCE-1 study (NCT06846515) is also a 12-month, randomized, double-blind, placebo-controlled trial. In its May 2026 announcement, Sobi reported that REDUCE-1 was fully enrolled, with results expected in the second half of 2026. The October announcement did not provide an updated readout or regulatory submission timeline.
REDUCE-2 will be presented as late-breaking abstract LB20 by investigator Puja P. Khanna, MD, MPH, on November 11, 2026, from 8:15 to 8:30 a.m. ET at the Chapin Theater during ACR Convergence 2026.
Clinical Interpretation: Serum Urate Reduction Requires Clinical Outcome Validation
REDUCE-2 provides Phase 3 evidence that once-daily pozdeutinurad can achieve substantial serum urate lowering compared with placebo in patients with gout. Both doses met the primary endpoint, with the 75 mg dose producing the higher numerical response rate and reductions sustained through 12 months.
However, achieving SU below 6 mg/dL represents a biochemical treatment outcome rather than direct evidence of improved clinical disease control. The forthcoming detailed results on gout flares, tophus reduction and longer-term safety will be important in determining whether the observed urate reduction translates into meaningful clinical benefit.
The findings support continued development of pozdeutinurad as a potential option for patients inadequately controlled on existing oral therapies. Nevertheless, the current results do not establish superiority over established treatments such as allopurinol or febuxostat, as no head-to-head comparison has been reported.
Reference
Late-breaking Phase 3 REDUCE-2 data show clinically meaningful and durable serum urate lowering with pozdeutinurad, SOBI, 29 October 2026
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302), ClinicalTrials.gov ID NCT06439602
About the Writer
Anamika Koshti (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, and evidence-based medicine. She has authored peer-reviewed publications on Alzheimer’s disease and PCOS, presented research at national conferences, and gained hands-on experience in medical content development and clinical data interpretation. She is committed to translating complex medical research into accurate, accessible content for healthcare professionals and patients.