Arthrosi Therapeutics, Inc. has announced the completion of enrollment for its pivotal Phase 3 REDUCE 2 trial, evaluating AR882 for the treatment of gout and tophaceous gout. The global study reached its target enrollment of 750 patients ahead of schedule.
REDUCE 2 Trial Details
REDUCE 2 is a 12-month, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of AR882 in patients with gout, including those who are inadequate responders to urate-lowering therapies (ULTs). Participants were randomized to receive either AR882 at 50 mg or 75 mg, or a placebo. The primary endpoint is the reduction of serum urate (sUA) levels by month six. Secondary endpoints include the reduction in the frequency of gout flares and the size of tophi over the course of the study. The trial is expected to be completed in the first half of 2026.
AR882: A Novel URAT1 Inhibitor
AR882 is a next-generation URAT1 inhibitor designed to reduce serum urate levels in patients with gout. By selectively inhibiting URAT1, AR882 aims to enhance uric acid excretion, thereby reducing the risk of crystal formation in joints and soft tissues. Phase 2 studies have demonstrated encouraging efficacy and safety profiles for AR882, including significant reductions in sUA levels and tophi size.
The Burden of Gout
Gout affects an estimated 13 million individuals in the U.S., with approximately 2 million suffering from tophaceous gout. This form of inflammatory arthritis results from the crystallization of uric acid within the joints and soft tissues, leading to painful flare-ups and chronic symptoms that can significantly impair mobility and quality of life. Current treatment strategies focus on managing sUA levels to prevent crystal deposition.
Future Plans
Building on the momentum of the REDUCE 2 trial, Arthrosi Therapeutics plans to initiate a replicate Phase 3 trial, REDUCE 1, in the first quarter of 2025. This additional study will further support the development and potential regulatory approval of AR882.
According to Dr. Robert T. Keenan, MD, MPH, Chief Medical Officer of Arthrosi Therapeutics, previous Phase 2 studies have shown a rapid and clinically meaningful decrease in sUA and tophi size, giving the company confidence in its ability to bring this potentially transformative, novel treatment to patients living with gout and significantly improve their quality of life.
