Sobi has reported detailed results from the pivotal Phase 3 REDUCE-2 study of pozdeutinurad in adults with uncontrolled gout, showing that both tested doses significantly increased the proportion of patients reaching the standard serum urate target at six months. The company announced the data on October 29 ahead of a late-breaking presentation at ACR Convergence 2026. Pozdeutinurad, previously known as AR882, is an investigational once-daily oral inhibitor of the urate transporter URAT1.

The global, randomised, double-blind study enrolled 811 patients and assigned them to pozdeutinurad 75 mg, pozdeutinurad 50 mg or placebo. At month six, 69.2 percent of patients receiving 75 mg and 56.6 percent receiving 50 mg had serum urate below 6 mg/dL, compared with 8.1 percent on placebo. Both comparisons were statistically significant with p values below 0.0001. Sobi said reductions were visible from month one and sustained through month 12.

The company also reported that more pozdeutinurad-treated patients reached progressively lower serum urate thresholds below 5, 4 and 3 mg/dL at each assessment. Those deeper thresholds can be relevant in severe disease, including patients with tophi, because sustained urate lowering supports dissolution of monosodium urate crystals. The disclosure did not provide the precise response rates at every lower threshold, so the magnitude of those secondary effects should be assessed when the full presentation and study report are available.

Treatment-emergent adverse events occurred in 60.7 percent of patients on 75 mg, 61.7 percent on 50 mg and 60.9 percent on placebo. That broad similarity is encouraging for a chronic oral medicine, but an overall event rate cannot by itself establish safety. Clinicians will need detail on serious events, renal and cardiovascular findings, laboratory abnormalities, discontinuations and individual adverse-event categories. URAT1 drug development has a history that makes renal and cardiovascular scrutiny particularly important, even when a new molecule is designed for greater selectivity.

Why it matters: gout is common, painful and potentially destructive, yet many patients remain above target despite available urate-lowering treatment. A once-daily medicine that brings a majority of uncontrolled patients below 6 mg/dL could expand options for people who do not achieve adequate control. The size and duration of REDUCE-2 also provide a more meaningful test than shorter Phase 2 studies, because urate lowering must be maintained long enough to alter the crystal burden that drives flares and tissue damage.

The result is one part of a broader Phase 3 programme. Pozdeutinurad is being studied in REDUCE-1 and REDUCE-2, both 12-month, placebo-controlled trials involving more than 800 patients in total. Consistency between the studies will matter for regulatory review. It will also be important to understand background therapies, flare prophylaxis, kidney-function subgroups and whether lower serum urate translates into clinical outcomes such as fewer flares or reduced tophus burden. A biochemical endpoint is well established in gout, but patients and prescribers ultimately care about symptoms, function and long-term tissue protection.

Sobi gained the programme through its acquisition of Selecta Biosciences assets associated with Arthrosi Therapeutics and is positioning it within specialty care. The newly released data strengthen the programme’s efficacy case, while leaving the usual late-stage questions about complete safety, reproducibility and regulatory expectations. The ACR presentation, scheduled for November 11, should provide a closer view of the dataset and may help determine how differentiated the two doses appear.

Dose selection will be another key issue. The 75 mg arm produced a 12.6 percentage-point higher six-month response rate than 50 mg, while the reported overall adverse-event frequency was similar. A regulator and prescriber will still need to see event severity, laboratory findings and discontinuations before concluding that the higher dose offers the stronger benefit-risk profile. Pricing and positioning will also depend on how pozdeutinurad compares with maximised standard therapy and with other options for difficult-to-control disease, not only with placebo.

For drug developers, REDUCE-2 is a reminder that mature programmes must connect target engagement to outcomes that matter in practice. Reaching a serum urate threshold is a credible intermediate goal, but durable adoption will depend on whether patients experience fewer flares, improved function and manageable treatment burden. The upcoming detailed presentation should therefore be read for both biochemical depth and clinical context, including adherence, concomitant medicines and the characteristics of participants who remained uncontrolled before enrolment.