Arthrosi Announces First Patient Dosed in Replicate Pivotal Phase 3 REDUCE 1 Trial of Lead Compound AR882
— REDUCE 1 is a study running in parallel with REDUCE 2 to evaluate AR882's efficacy in lowering serum urate (sUA) levels in gout patients —
SAN DIEGO, March 17, 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 that it has dosed the first patient in REDUCE 1, the Company's second pivotal Phase 3 clinical trial evaluating AR882.
"We are pleased to have enrolled the first patient in our REDUCE 1 study, our second confirmatory Phase 3 trial evaluating AR882's potential as a best-in-class treatment," said Litain Yeh, Ph.D., Founder and CEO of Arthrosi Therapeutics. "This milestone, together with the rapid completion of enrollment in our Phase 3 REDUCE 2 study, continues to build momentum as we progress towards a New Drug Application for AR882 and deliver a much-needed treatment option that could significantly improve patient outcomes."
REDUCE 1 is the Company's second pivotal twelve-month, randomized, double-blind, placebo-controlled study evaluating AR882. The study is expected to enroll up to 750 patients with gout who are inadequate responders to urate lowering therapies (ULTs) and ULT naïve. Patients will be randomized into one of three groups either receiving AR882 50 mg, AR882 75mg or placebo. All patients will receive Prophylaxis at least 10 days prior to dosing and continue for 3 months. The primary endpoint is reduction of sUA by month six. Secondary endpoints include a reduction in flare and tophi over time. The trial is expected to be fully enrolled in 2025 and completed by the end of 2026.
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.
Media Contact:
Shunqi Yan, PhD
Founder & Chief Operating Officer
shunqi.yan@arthrosi.com
Investor Contact:
Precision AQ
Alex Lobo
212-698-8802
alex.lobo@precisionaq.com
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SOURCE Arthrosi Therapeutics