Arthrosi Announces First Patient Dosed in Pivotal Phase 3 REDUCE 2 Trial of Lead Compound AR882

2024-06-27

临床2期临床3期申请上市临床结果

— REDUCE 2 is a global study that will evaluate reduction of sUA in gout patients and support a New Drug Application (NDA) submission package —

— REDUCE 2 will be conducted in parallel with a replicate study REDUCE 1, expected to initiate in the second half of 2024 —

SAN DIEGO, June 27, 2024 /PRNewswire/ -- Arthrosi Therapeutics, Inc., a late-stage biotechnology company developing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor URAT1 inhibitor to reduce serum urate levels, flares and Tophi in patients with gout, today announced that it has dosed the first patient in REDUCE 2, a pivotal Phase 3 clinical trial to evaluate reduction of sUA in gout patients.

"We are pleased to announce the dosing of the first patient in our pivotal Phase 3 trial evaluating AR882. Uncontrolled gout represents a significant unmet medical need with approximately two million patients in the U.S. alone who could benefit from a safer and more efficacious treatment option," commented Litain Yeh, Founder and CEO of Arthrosi Therapeutics. "We look forward to building upon our comprehensive data package of AR882 including the positive results from our Phase 2 AR882-202 and AR882-203 studies, which collectively demonstrated significant reduction in serum urate (sUA) levels as well as a significant decrease of tophi, crystal burden and flare rates compared to standard of care. This continued progress underscores our commitment to developing a safer, more efficacious and convenient therapy to reduce sUA levels in patients living with gout. We look forward to rapidly enrolling patients in the study and expect to initiate the second pivotal REDUCE 1 study in the second half of 2024."

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 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 completed in late 2026.

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.

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 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.

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

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