Sobi’s Phase 3 REDUCE 2 trial of pozdeutinurad met its primary endpoint in gout patients, showing robust urate‑lowering efficacy and consistent safety profile.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Sobi announced positive topline results from the pivotal Phase 3 REDUCE-2 trial (NCT06439602) evaluating pozdeutinurad (AR882), an investigational oral URAT1 inhibitor, in adults with gout inadequately controlled by standard urate‑lowering therapies.
The study met its primary endpoint, with significantly more patients achieving target serum uric acid (sUA) levels below 6 mg/dL at six months versus placebo. At month six, 69.2% of patients receiving pozdeutinurad 75 mg achieved sUA <6 mg/dL compared with 8.1% in the placebo arm (p<0.0001). The 50 mg dose achieved sUA <6 mg/dL in 56.6% of patients versus 8.1% with placebo (p<0.0001).
Trial Design and Patient Population
REDUCE 2 enrolled 811 patients with inadequate responses to prior urate‑lowering therapies. Participants were randomized to receive pozdeutinurad 50 mg, pozdeutinurad 75 mg, or placebo in a 12‑month, double‑blind study.
Secondary Endpoints and Safety
Secondary endpoints included reductions in gout flares, tophi burden, and long‑term disease control. Detailed analyses will be presented at an upcoming scientific congress. Sobi reported that the safety profile remained consistent with earlier studies, with no new tolerability signals observed.
Mechanism of Action
Pozdeutinurad selectively inhibits URAT1, a renal transporter involved in uric acid reabsorption. By blocking URAT1, the therapy increases uric acid excretion and lowers circulating urate levels that drive crystal deposition, inflammation, and recurrent gout flares.
Executive Commentary
“Results from REDUCE-2 support the potential of pozdeutinurad to address a major unmet need in patients whose disease remains poorly controlled despite available therapies,” said Lydia Abad‑Franch, MD, Head of R&D and Medical Affairs and Chief Medical Officer at Sobi. “We observed sustained urate lowering with a favorable efficacy and tolerability profile.”
Pipeline Context
Pozdeutinurad entered Sobi’s pipeline following the company’s February 2026 acquisition of Arthrosi, Inc. The drug is being evaluated in two global Phase 3 studies, REDUCE-1 and REDUCE 2, each enrolling more than 800 patients. REDUCE-1 has completed enrollment, with data expected in the second half of 2026. Detailed REDUCE-2 results are scheduled for presentation at a scientific congress in Q4 2026.
Clinical Need
Gout is the most common inflammatory arthritis worldwide. While standard urate‑lowering therapies benefit many patients, a substantial proportion fail to reach target uric acid levels or continue to experience flares, tophi formation, joint damage, and cardiovascular or renal complications.
Reference
Positive topline results from the pivotal Phase 3 REDUCE 2 study of pozdeutinurad in gout | Sobi
About the Writer
Nikita Jha, BPharm (LinkedIn) a pharmacy graduate specializing in medical writing, with a strong ability to interpret complex medical and regulatory information and translate it into clear, accurate, and evidence-based healthcare content. Known for her attention to detail and precision, she focuses on delivering high-quality scientific communication that supports drug safety and informed decision-making.