Arthrosi Therapeutics完成AR882治疗痛风和痛风石痛风的关键3期REDUCE 2试验的患者招募工作-动脉网

Arthrosi Therapeutics Completes Enrollment in Pivotal Phase 3 REDUCE 2 Trial of AR882 for the Treatment of Gout and Tophaceous Gout

CISION 等信源发布 2025-03-05 20:59

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REDUCE 2 enrollment completed well ahead of schedule—

REDUCE 2 招募工作提前完成——

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Plan to initiate replicate Phase 3 trial, REDUCE 1, in 1Q25 —

计划在25年第一季度启动复制的第三阶段试验，REDUCE 1，——

SAN DIEGO

圣地亚哥

，

March 5, 2025

2025年3月5日

/PRNewswire/ -- Arthrosi Therapeutics, Inc., a late-stage biotechnology company developing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate (sUA) levels, flares, and dissolve tophi in gout and tophaceous gout patients, today announced the completion of enrollment for its pivotal global Phase 3 REDUCE 2 trial..

/PRNewswire/ -- Arthrosi Therapeutics, Inc.是一家处于后期阶段的生物技术公司，致力于开发潜在的最佳、高效且选择性强的新一代URAT1抑制剂，以降低血清尿酸（sUA）水平、减少痛风和痛风石患者的发作及溶解痛风石。该公司今日宣布其关键的全球3期REDUCE 2试验已完成入组。

'We would like to thank the gout community for its support, trust and participation as we complete this important step in the advancement of the AR882 program,' said Dr.

“我们要感谢痛风社区在我们完成AR882项目这一重要步骤时给予的支持、信任和参与，”博士表示。

Robert T. Keenan

罗伯特·T·基南

, 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 us confidence in our ability to bring this potentially transformative, novel treatment to patients living with gout and significantly improve their quality of life.'.

医学博士、公共卫生硕士、Arthrosi Therapeutics 首席医学官。“之前 II 期研究显示，血清尿酸 (sUA) 和痛风石体积迅速且有临床意义的下降，这让我们有信心为痛风患者带来这种可能具有变革性的新型疗法，并显著改善他们的生活质量。”

REDUCE 2 is a pivotal twelve-month, randomized, double-blind, placebo-controlled study. The study has reached its target enrollment of 750 patients globally with a majority being inadequate responders to urate lowering therapies (ULTs). Patients are randomized into one of three groups either receiving AR882 50 mg, AR882 75mg or placebo.

REDUCE 2 是一项关键的为期十二个月的随机、双盲、安慰剂对照研究。该研究已在全球范围内达到其目标入组人数750名患者，其中大多数是对降尿酸疗法（ULTs）反应不佳的患者。患者被随机分为三组，分别接受AR882 50 mg、AR882 75 mg或安慰剂治疗。

The primary endpoint is reduction of sUA by month six. Secondary endpoints include a reduction in flares and tophi over time. The trial is expected to be completed in the first half of 2026..

六个月时sUA的降低是主要终点。次要终点包括随着时间的推移痛风发作和痛风石的减少。该试验预计在2026年上半年完成。

For more information about REDUCE 2, please visit

有关 REDUCE 2 的更多信息，请访问

https://clinicaltrials.gov/

(identifier

(标识符

NCT06439602

）。

About Arthrosi:

关于Arthrosi：

Arthrosi Therapeutics, Inc., headquartered in

关节炎治疗公司，总部位于

San Diego, CA

加利福尼亚州圣地亚哥

, is focused on developing AR882, a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with gout. AR882 has demonstrated encouraging efficacy and safety compared to SOC in Phase 2 studies as well as impressive results in achieving complete resolution of tophi in a Phase .

专注于开发AR882，一种潜在的最佳同类药物，高效且选择性强的下一代URAT1抑制剂，用于降低痛风患者的血清尿酸水平、急性发作和痛风石。在二期研究中，与标准治疗相比，AR882展现了令人鼓舞的有效性和安全性，同时在实现痛风石完全消退方面取得了令人印象深刻的结果。

study. Arthrosi is currently advancing AR882 in a pivotal Phase 3 program.

研究。Arthrosi公司目前正在关键的III期项目中推进AR882。

About Gout:

关于痛风：

In the U.S., an estimated 13 million individuals are diagnosed with gout, ~2 million of which have tophaceous gout. Gout is a form of inflammatory arthritis that can significantly diminish mobility, functionality, and overall quality of life. Gout emerges from the crystallization of uric acid within the joints and soft tissue, instigating painful flare-ups and chronic symptoms.

在美国，估计有 1300 万人被诊断出患有痛风，其中约 200 万人患结节性痛风。痛风是一种炎症性关节炎，会显著降低活动能力、功能性和整体生活质量。痛风是由尿酸在关节和软组织中结晶化引发的，导致疼痛发作和慢性症状。

The kidneys play a pivotal role in the process, as they are responsible for filtering out and excreting uric acid from the body. In over 90% of gout patients, underexcretion of uric acid results in the imbalanced and elevated sUA levels that can lead to the deposition of uric acid crystals. It's essential to monitor and manage sUA levels as part of comprehensive gout treatment and prevention strategies..

肾脏在这一过程中起着关键作用，因为它们负责过滤并排出体内的尿酸。超过90%的痛风患者由于尿酸排泄不足，导致血尿酸水平失衡和升高，可能引发尿酸盐结晶沉积。作为全面痛风治疗和预防策略的一部分，监测和管理血尿酸水平至关重要。

Media Contact:

媒体联系人:

Shunqi Yan, PhD

严顺奇，博士

Founder & Chief Operating Officer

创始人兼首席运营官

shunqi.yan@arthrosi.com

严顺奇@arthrosi.com

Investor Contact:

投资者联系方式：

Precision AQ