Arthrosi Therapeutics Surpasses 50% Patient Enrollment in Pivotal Phase 3 REDUCE 2 Trial of AR882 in Patients with Gout, Including Those with Tophaceous Gout

— Company anticipates completion of patient enrollment in 1H 2025 —

SAN DIEGO, Dec. 18, 2024 /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 levels, flares and tophi in patients with gout, today announced that it has enrolled more than 50% of patients in its pivotal Phase 3 REDUCE 2 trial evaluating AR882 for the reduction of sUA in gout patients.

"We are excited by the momentum we have seen in the REDUCE 2 study since enrolling the first patient in July 2024. This is a reflection of the commitment of our team and clinical collaborators as we seek to redefine the standard of care for patients with gout," said Litain Yeh, Ph.D., Founder and CEO of Arthrosi Therapeutics. "With our REDUCE 2 study well ahead of its projected schedule, we expect to complete enrollment in the first half of 2025, and in parallel, plan to initiate our REDUCE 1 study, a replicate Phase 3 study in the first quarter of 2025."

Dr. Robert T. Keenan, MD, MPH, Chief Medical Officer at Arthrosi Therapeutics added, "There remains a large unmet need for a safe and convenient gout treatment, which can provide clinical benefit with reduction of tophi and flares. We remain highly encouraged by the potential of AR882 and believe that our pivotal phase 3 program will support a comprehensive New Drug Application to the U.S. Food and Drug Administration as we seek to improve the lives of all gout patients."

REDUCE 2 is a pivotal twelve-month, randomized, double-blind, placebo-controlled study. The study is expected to enroll up to 750 patients globally with gout who are inadequate responders to urate lowering therapies (ULTs) and ULT naïve. Patients are randomized into one of three groups either receiving AR882 50 mg, AR882 75mg or placebo. All patients 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 completed in late 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. Gout remains a large and growing market with ~ 13M patients in the U.S. alone, ~2M of which have tophaceous 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. 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
[email protected]

Investor Contact:
Precision AQ
Alex Lobo
212-698-8802
[email protected]

SOURCE Arthrosi Therapeutics