Arthrosi Therapeutics Kicks Off Phase 3 REDUCE 1 Trial for Gout Treatment with First Patient Dosed

Arthrosi Therapeutics Launches Phase 3 REDUCE 1 Trial for AR882

Arthrosi Therapeutics, Inc., a biotechnology company at the forefront of developing innovative solutions for gout treatment, has recently announced a significant advancement in its research efforts. On March 17, 2025, the company revealed that it has successfully dosed the first patient in the REDUCE 1 clinical trial, which is pivotal for the investigation of AR882, their leading therapeutic compound.

About the REDUCE 1 Trial

The REDUCE 1 trial represents a major step forward in assessing the efficacy of AR882, a highly selective URAT1 inhibitor designed to effectively lower serum urate (sUA) levels among patients suffering from gout and tophaceous gout. This trial will run in parallel with the REDUCE 2 study, creating a robust framework for comparative analysis and validation of the therapy's potential benefits.

The objective of the trial is to involve approximately 750 participants who have not adequately responded to existing urate-lowering treatments or those who are new to treatment. Participants will be randomly assigned to receive either a dose of AR882 (50 mg or 75 mg) or a placebo, with the entire study being double-blinded to maintain research integrity. All patients will undergo prophylactic treatment beginning at least ten days before receiving the trial medication and will continue for three months.

Key Study Objectives and Timeline

The primary goal of the REDUCE 1 trial is to demonstrate a statistically significant reduction in sUA levels by the six-month mark. In addition, secondary endpoints will track reductions in flare frequency and tophi size throughout the trial duration. With the anticipated completion of patient enrollment in 2025 and a full analysis expected by late 2026, results from this study could pave the way for a New Drug Application (NDA) for AR882.

Insights from Leadership

Dr. Litain Yeh, the Founder and CEO of Arthrosi Therapeutics, expressed enthusiasm regarding this new trial phase. He stated, "We are pleased to have enrolled the first patient in our REDUCE 1 study, our second confirmatory Phase 3 trial evaluating AR882's potential as a best-in-class treatment. This achievement, along with the swift completion of the REDUCE 2 enrollment, underscores our commitment to advancing this much-needed therapy for gout patients."

The Challenge of Gout

Currently, gout affects an estimated 13 million individuals in the United States, with approximately 2 million experiencing the more severe variant, tophaceous gout. This form of inflammatory arthritis results from the crystallization of uric acid within joints, leading to painful flares and chronic discomfort. Given the kidneys' essential role in excreting uric acid, addressing the underlying issues related to serum urate levels is critical for effective gout management.

Conclusion

As the REDUCE 1 trial progresses, the medical community and gout patients alike will be watching closely. If successful, AR882 could transform the landscape of gout treatment, offering hope for improved quality of life for millions affected by this often debilitating condition. Arthrosi Therapeutics remains committed to delivering this innovative therapy, marking a potential turning point in gout management. As the trial moves forward, updates on further patient enrollment and interim results are anticipated, contributing to the growing body of research surrounding gout treatments.