Arthrosi Therapeutics Finalizes Enrollment for Phase 3 REDUCE 2 Trial of AR882 for Gout Treatment

Arthrosi Therapeutics, Inc., a biotechnology company based in San Diego, has announced the successful completion of patient enrollment for its pivotal global Phase 3 trial, REDUCE 2. This trial focuses on a new treatment for gout, a condition affecting millions worldwide. Arthrosi is advancing the development of AR882, a next-generation URAT1 inhibitor, which is designed to significantly reduce serum urate (sUA) levels, reduce gout flares, and dissolve tophi in patients suffering from gout and tophaceous gout.

The REDUCE 2 trial is a critical step in the company's efforts to deliver an innovative solution for those dealing with gout. The trial is a twelve-month, randomized, double-blind, placebo-controlled study. It has successfully enrolled 750 patients globally, a majority of whom are inadequate responders to existing urate lowering therapies (ULTs). Participants in the study are randomized into three groups: those receiving either AR882 at doses of 50 mg or 75 mg, and a placebo group. The primary goal of the study is to achieve a reduction in serum urate levels by the sixth month. Additionally, secondary objectives include monitoring the reduction of flares and tophi over the duration of the trial. The study is expected to conclude in the first half of 2026.

Dr. Robert T. Keenan, Chief Medical Officer of Arthrosi Therapeutics, expressed gratitude towards the gout community for its support and participation in the trial. He emphasized the promising results from previous studies, which indicated a rapid and clinically meaningful decrease in both serum urate levels and tophi size. These findings bolster confidence in AR882's potential to transform the treatment landscape for gout patients and enhance their quality of life.

Gout is a prevalent inflammatory arthritis condition in the United States, with an estimated 13 million individuals affected, approximately 2 million of whom suffer from tophaceous gout. This painful condition arises from the crystallization of uric acid in the joints and soft tissues, leading to episodes of intense pain and chronic discomfort. The kidneys play a crucial role in managing this condition by filtering and excreting uric acid. However, in over 90% of gout patients, there is an underexcretion of uric acid, which can lead to elevated serum urate levels and the formation of uric acid crystals. Managing and monitoring serum urate levels is essential for effective gout treatment and prevention strategies.

Arthrosi Therapeutics is dedicated to advancing the development of AR882, which has shown promising efficacy and safety in Phase 2 studies. These studies have also demonstrated impressive results in achieving complete resolution of tophi in a Phase 2b trial. The company is committed to providing a potentially best-in-class treatment for gout, aiming to improve the lives of millions affected by this condition.

With the REDUCE 2 trial progressing as planned, Arthrosi Therapeutics has its sights set on initiating a replicate Phase 3 trial, REDUCE 1, in the first quarter of 2025. The continued advancement of AR882 represents a significant stride forward in addressing the unmet needs of gout patients, promising a future with improved treatment options and enhanced patient outcomes.