Arthrosi Therapeutics Achieves Major Milestone in Gout Treatment Trial with AR882

Arthrosi Therapeutics’ Progress in Gout Treatment

Arthrosi Therapeutics, Inc., a late-stage biotechnology firm based in San Diego, California, has made significant strides in its clinical trial for AR882, a next-generation URAT1 inhibitor aimed at combatting gout. Recently, the company announced that it has surpassed the 50% enrollment milestone in its pivotal Phase 3 REDUCE 2 trial, which focuses on patients suffering from gout, including the more severe tophaceous variant.

The REDUCE 2 trial, initiated in July 2024, has garnered notable momentum. According to Dr. Litain Yeh, the founder and CEO of Arthrosi Therapeutics, this rapid progress reflects not only the commitment of their team but also the strong engagement with clinical collaborators. The company expects to complete patient enrollment by the first half of 2025, demonstrating the efficacy of their outreach efforts.

AR882 is designed to lower serum urate levels and reduce the incidence of painful gout flare-ups and the size of tophi, which are deposits of uric acid crystals that can form in various body tissues. The study aims to evaluate the drug’s effectiveness over a twelve-month randomized, double-blind, placebo-controlled framework, enrolling approximately 750 patients who do not adequately respond to current urate-lowering therapies or have not yet begun treatment (ULT naïve).

Patients enrolled in the study are randomized to receive either 50 mg or 75 mg doses of AR882, or a placebo. Importantly, all participants receive prophylactic treatment at least ten days prior to the dosing regimen, which continues for three months. The primary endpoint of this trial is to assess the reduction of serum urate levels by the sixth month. Secondary endpoints are focused on decreasing flare frequency and reducing the size of tophi over time.

The expected completion date for the trial is late 2026, which is in alignment with the regulatory timelines for a new drug application to the U.S. Food and Drug Administration (FDA). Dr. Robert T. Keenan, Chief Medical Officer at Arthrosi Therapeutics, emphasized the critical unmet needs in gout treatment, highlighting that many current therapies are not sufficiently effective or convenient.

Gout affects approximately 13 million people within the United States, with around 2 million diagnosed with the severe form known as tophaceous gout. It arises from the accumulation of uric acid crystals in joints due to the kidneys' inability to excrete enough uric acid. Thus, managing serum urate levels is essential to managing this condition.

Arthrosi's AR882 has shown promising efficacy in earlier Phase 2 studies and has stood out due to its potential to fully resolve tophi in participants, offering hope to those suffering. The REDUCE 2 trial represents a pivotal moment for both the company and the future treatment landscape for gout, and the anticipation continues to grow as enrollment progresses and new data emerges.

As the medical community watches closely, the outcomes of this study may pave the way for significant advancements in how gout is treated, stressing the importance of innovative therapies like AR882 in addressing a large and growing patient population. As of now, Arthrosi is channeling its resources into maintaining the pace of this study, which holds the promise of changing lives for gout patients everywhere.