Arthrosi Doses First Patient in Phase 3 REDUCE 2 Trial of AR882

Arthrosi Therapeutics, Inc., a biotechnology company based in San Diego, has initiated the first patient dosing in its pivotal Phase 3 clinical trial, REDUCE 2. This trial aims to assess the effectiveness of AR882, a next-generation URAT1 inhibitor, in reducing serum urate levels in patients with gout. The study is a critical step toward addressing the treatment needs of approximately two million gout patients in the U.S. who require safer and more effective therapies.

Litain Yeh, the Founder and CEO of Arthrosi Therapeutics, expressed enthusiasm about the progress of AR882. He highlighted the significant unmet medical need for better gout treatments and pointed to the promising data from previous Phase 2 studies. These earlier studies revealed that AR882 effectively lowered serum urate levels, reduced tophi, and decreased flare rates compared to existing treatments. Yeh emphasized the company's dedication to rapidly enrolling patients and initiating a second pivotal study, REDUCE 1, in the latter half of 2024.

REDUCE 2 is designed as a twelve-month, randomized, double-blind, placebo-controlled trial. It will enroll up to 750 gout patients globally who either have not responded adequately to current urate-lowering therapies or have not been previously treated with them. Participants will be randomly assigned to receive either AR882 at doses of 50 mg or 75 mg, or a placebo. Prophylactic treatment will begin at least ten days before dosing and continue for three months. The primary goal of the trial is to achieve a reduction in serum urate levels by the sixth month, while secondary objectives include monitoring reductions in gout flares and tophi over time. Completion of the trial is projected for late 2026.

Gout is a prevalent form of inflammatory arthritis, affecting an estimated 13 million people in the U.S. It arises from the accumulation of uric acid crystals in joints and soft tissues, leading to painful flare-ups and chronic symptoms. The kidneys are crucial in managing uric acid levels by filtering and excreting it from the body. In most gout patients, the kidneys underperform in this role, resulting in elevated serum urate levels and the formation of uric acid crystals. Effective management of serum urate levels is essential for treating and preventing gout.

Arthrosi Therapeutics is committed to advancing AR882 as a potentially best-in-class treatment for gout. With encouraging efficacy and safety data from Phase 2 studies, AR882 has shown promise in resolving tophi, a common and severe complication of gout. The company's ongoing Phase 3 program aims to further establish AR882's effectiveness and safety, providing a much-needed option for gout patients.

In conclusion, the initiation of the REDUCE 2 trial marks a significant milestone for Arthrosi Therapeutics in its mission to develop superior gout treatments. With the potential to improve the quality of life for millions of gout sufferers, AR882 represents a promising advancement in the management of this chronic condition.