— Enrollment completed well ahead of schedule; both Phase 3 trials now fully enrolled with data expected in Q2 2026 —
SAN DIEGO, Aug. 20, 2025 /PRNewswire/ -- Arthrosi Therapeutics, Inc., a late-stage biotechnology company advancing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate (sUA) levels, flares, and dissolve tophi in gout and tophaceous gout patients, today announced the completion of patient enrollment in its second pivotal global Phase 3 trial, REDUCE 1, evaluating pozdeutinurad (formerly AR882) for the reduction of sUA and tophi in gout and tophaceous gout patients.
"Following the full enrollment of our REDUCE 2 trial in Q1 2025, we are pleased to announce that REDUCE 1 has also reached full enrollment well ahead of schedule. This milestone marks another critical step towards our mission of delivering a much-needed, differentiated treatment option for patients with gout and tophaceous gout. The remarkable pace of enrollment in both our REDUCE 1 and REDUCE 2 studies is a testament to the strong demand among clinicians and patients for safer and more effective treatments for this painful and often debilitating disease," said Dr. Robert T. Keenan, MD, MPH, Chief Medical Officer at Arthrosi Therapeutics. "With both of our Phase 3 trials now fully enrolled, we remain on track to deliver data in the second and fourth quarter of 2026 for both Phase 3 trials to support a planned NDA submission for pozdeutinurad. We're grateful to the investigators, caregivers, and patients for their continued enthusiasm and participation in our Phase 3 program."
REDUCE 1 is a pivotal twelve-month, randomized, double-blind, placebo-controlled study evaluating pozdeutinurad. The study has reached its target enrollment of 750 patients globally with a majority being inadequate responders to urate lowering therapies (ULTs). Patients are randomized into one of three groups either receiving pozdeutinurad 50 mg, pozdeutinurad 75mg or placebo. The primary endpoint is reduction of sUA by month six. Secondary endpoints include tophi and flare reduction. The company expects to share a comprehensive data update in Q4 2026.
About Arthrosi:
Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing pozdeutinurad (AR882), a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with gout. Pozdeutinurad has demonstrated encouraging efficacy and safety compared to SOC in Phase 2 studies as well as impressive results in achieving complete resolution of tophi in a Phase 2b study. Arthrosi is currently advancing pozdeutinurad in a pivotal Phase 3 program.
About Gout:
In the U.S., an estimated 13 million individuals are diagnosed with gout, ~2 million of which have tophaceous gout. Gout is a form of inflammatory arthritis that can significantly diminish mobility, functionality, and overall quality of life. Gout emerges from the crystallization of uric acid within the joints and soft tissue, instigating painful flare-ups and chronic symptoms. The kidneys play a pivotal role in the process, as they are responsible for filtering out and excreting uric acid from the body. In over 90% of gout patients, underexcretion of uric acid results in the imbalanced and elevated sUA levels that can lead to the deposition of uric acid crystals. It's essential to monitor and manage sUA levels as part of comprehensive gout treatment and prevention strategies.
Investor Contact:
Shunqi Yan, PhD
Founder & Chief Operating Officer
shunqi.yan@arthrosi.com
Precision AQ Contact:
Alex Lobo
212-698-8802
alex.lobo@precisionaq.com
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SOURCE Arthrosi Therapeutics
