Arthrosi Therapeutics Completes Enrollment in Pivotal Phase 3 REDUCE 2 Trial of AR882 for the Treatment of Gout and Tophaceous Gout
— REDUCE 2 enrollment completed well ahead of schedule—
— Plan to initiate replicate Phase 3 trial, REDUCE 1, in 1Q25 —
SAN DIEGO, March 5, 2025 /PRNewswire/ -- Arthrosi Therapeutics, Inc., a late-stage biotechnology company developing 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 enrollment for its pivotal global Phase 3 REDUCE 2 trial.
'We would like to thank the gout community for its support, trust and participation as we complete this important step in the advancement of the AR882 program,' said Dr. Robert T. Keenan, MD, MPH, Chief Medical Officer of Arthrosi Therapeutics. 'Previous Phase 2 studies have shown a rapid and clinically meaningful decrease in sUA and tophi size, giving us confidence in our ability to bring this potentially transformative, novel treatment to patients living with gout and significantly improve their quality of life.'
REDUCE 2 is a pivotal twelve-month, randomized, double-blind, placebo-controlled study. 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 AR882 50 mg, AR882 75mg or placebo. The primary endpoint is reduction of sUA by month six. Secondary endpoints include a reduction in flares and tophi over time. The trial is expected to be completed in the first half of 2026.
For more information about REDUCE 2, please visit https://clinicaltrials.gov/ (identifier NCT06439602).
About Arthrosi:
Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing 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. AR882 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 AR882 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.
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