STOCKHOLM, Sweden, October 29, 2026
Swedish Orphan Biovitrum AB (Sobi) has announced positive late-breaking results from its pivotal Phase 3 REDUCE-2 clinical trial evaluating pozdeutinurad (AR882), an investigational oral medicine for patients with uncontrolled gout. The findings demonstrate clinically meaningful and sustained reductions in serum urate levels over 12 months, with significantly more patients achieving recommended urate targets compared with placebo. The results were presented as part of the scientific programme at ACR Convergence 2026, highlighting the potential of pozdeutinurad as a future treatment option for patients who do not achieve adequate disease control with existing oral therapies. The global study met its primary endpoint, demonstrating statistically significant improvements in serum urate reduction with both evaluated doses. Sobi reported that the treatment also showed a safety profile generally comparable to placebo, representing an important development in its clinical programme targeting uncontrolled gout.
Phase 3 REDUCE-2 Trial Meets Primary Endpoint
The global Phase 3 REDUCE-2 study enrolled 811 patients with gout, who were randomly assigned to receive once-daily pozdeutinurad at doses of 75 mg or 50 mg, or placebo. The primary endpoint evaluated the proportion of patients achieving serum urate (SU) levels below 6 mg/dL at Month 6. According to Sobi, the trial achieved this primary objective, with 69.2% of patients receiving pozdeutinurad 75 mg achieving the target, compared with 56.6% of those receiving the 50 mg dose. In contrast, only 8.1% of participants receiving placebo achieved the same target. Both treatment groups demonstrated statistically significant improvements compared with placebo, with p-values below 0.0001. Importantly, clinically meaningful serum urate reductions were observed as early as the first month of treatment and were maintained through the 12-month study period. At each assessment throughout the trial, a greater proportion of patients receiving pozdeutinurad achieved serum urate thresholds below 6, 5, 4 and 3 mg/dL compared with placebo. These findings indicate sustained urate-lowering activity across both evaluated doses and support further investigation of the medicine in patients with inadequately controlled gout.
Pozdeutinurad Demonstrates Sustained Urate Reduction and Safety
A key finding from REDUCE-2 was the consistency of serum urate reduction throughout the 12-month evaluation period. Maintaining serum urate levels below recommended thresholds is an important objective in gout management because persistent urate accumulation can contribute to the formation of monosodium urate crystals in joints and surrounding tissues. These deposits can trigger painful inflammatory attacks, damage joints and lead to the development of tophi, which are deposits of urate crystals under the skin. Sobi reported that the incidence of treatment-emergent adverse events was similar across all three study groups. Adverse events occurred in 60.7% of patients receiving pozdeutinurad 75 mg, 61.7% receiving 50 mg and 60.9% receiving placebo. The company described the overall safety profile as generally comparable to placebo. These findings are relevant because patients with uncontrolled gout may require long-term treatment to maintain urate reduction and prevent disease progression. The results provide additional evidence supporting the continued clinical development of pozdeutinurad as a potential treatment for this patient population.
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Selective URAT1 Inhibition Offers a New Treatment Approach
Pozdeutinurad (AR882) is an investigational, once-daily oral medicine designed as a highly selective inhibitor of the urate transporter 1 (URAT1). This transporter plays an important role in regulating uric acid reabsorption in the kidneys. By inhibiting URAT1, pozdeutinurad is designed to increase the elimination of uric acid through urine, thereby lowering circulating serum urate levels. The treatment is being developed for patients with uncontrolled gout who continue to experience elevated urate levels despite available oral urate-lowering therapies. Earlier Phase 2 studies reported clinically meaningful reductions in serum urate, dissolution of tophi and a generally well-tolerated safety profile. The broader Phase 3 development programme includes two 12-month randomized, double-blind, placebo-controlled studies, REDUCE-1 and REDUCE-2, evaluating the medicine in more than 800 patients. The latest REDUCE-2 findings add important clinical evidence to this programme and strengthen the understanding of pozdeutinurad’s potential therapeutic activity.
The positive Phase 3 findings represent an important milestone for Sobi’s gout treatment development programme and its efforts to address unmet medical needs in inflammatory diseases. The company plans to continue evaluating the clinical evidence generated across its Phase 3 programme. Although the results are encouraging, pozdeutinurad remains an investigational medicine and has not yet received regulatory approval for gout treatment. Further clinical evaluation and regulatory review will be required before it can become available as an approved treatment. The sustained serum urate reductions observed over 12 months nevertheless provide encouraging evidence for the potential role of selective URAT1 inhibition in managing uncontrolled gout.
Source: Sobi press release
