— REDUCE 2 is a global study that will evaluate reduction of sUA in gout patients and support a New Drug Application (NDA) submission package —

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— REDUCE 2 will be conducted in parallel with a replicate study REDUCE 1, expected to initiate in the second half of 2024 —

-REDUCE 2将与REDUCE 1重复研究同时进行，预计将于2024年下半年启动-

SAN DIEGO, June 27, 2024 /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 levels, flares and Tophi in patients with gout, today announced that it has dosed the first patient in REDUCE 2, a pivotal Phase 3 clinical trial to evaluate reduction of sUA in gout patients..

圣地亚哥，2024年6月27日/PRNewswire/--Arthrosi Therapeutics，Inc.，一家晚期生物技术公司，开发了一种潜在的同类最佳，高效和选择性的下一代URAT1抑制剂，以降低痛风患者的血清尿酸盐水平，耀斑和痛风石，今天宣布，它已经给第一名患者服用了reduce 2，这是一项评估痛风患者sUA降低的关键3期临床试验。。

'We are pleased to announce the dosing of the first patient in our pivotal Phase 3 trial evaluating AR882. Uncontrolled gout represents a significant unmet medical need with approximately two million patients in the U.S. alone who could benefit from a safer and more efficacious treatment option,' commented Litain Yeh, Founder and CEO of Arthrosi Therapeutics.

“我们很高兴地宣布，在我们评估AR882的关键性3期试验中，第一名患者的剂量。Arthrosi Therapeutics创始人兼首席执行官叶立丹（Litain Yeh）评论说，不受控制的痛风代表着一个严重的未满足的医疗需求，仅在美国就有大约200万患者可以从更安全和更有效的治疗选择中受益。

'We look forward to building upon our comprehensive data package of AR882 including the positive results from our Phase 2 AR882-202 and AR882-203 studies, which collectively demonstrated significant reduction in serum urate (sUA) levels as well as a significant decrease of tophi, crystal burden and flare rates compared to standard of care.

“我们期待着在AR882的综合数据包的基础上进一步发展，包括我们第二阶段AR882-202和AR882-203研究的积极结果，这些研究共同证明血清尿酸盐（sUA）水平显着降低，并且与标准护理相比，痛风石，晶体负担和耀斑率显着降低。

This continued progress underscores our commitment to developing a safer, more efficacious and convenient therapy to reduce sUA levels in patients living with gout. We look forward to rapidly enrolling patients in the study and expect to initiate the second pivotal REDUCE 1 study in the second half of 2024.'.

这一持续的进展强调了我们致力于开发一种更安全，更有效和方便的治疗方法，以降低痛风患者的sUA水平。我们期待着迅速招募患者参加这项研究，并期望在2024年下半年启动第二项关键的REDUCE 1研究。”。

REDUCE 2 is a pivotal twelve-month, randomized, double-blind, placebo-controlled study. The study is expected to enroll up to 750 patients globally with gout who are inadequate responders to urate lowering therapies (ULTs) and ULT naïve. Patients will be 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12个月的随机双盲安慰剂对照研究。该研究预计将在全球范围内招募750名痛风患者，这些患者对降尿酸治疗（ULTs）和ULT天真的反应不足。患者将被随机分为三组，分别接受AR882 50 mg，AR882 75mg或安慰剂。

All patients will receive Prophylaxis at least 10 days prior to dosing and continue for 3 months. The primary endpoint is reduction of sUA by month six. Secondary endpoints include a reduction in flare and tophi over time. The trial is expected to be completed in late 2026..

所有患者将在给药前至少10天接受预防，并持续3个月。主要终点是在第六个月减少sUA。次要终点包括随着时间的推移耀斑和tophi的减少。该试验预计将于2026年末完成。。

About Gout:In the U.S., an estimated 13 million individuals are diagnosed with 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.

关于痛风：在美国，估计有1300万人被诊断患有痛风。痛风是一种炎性关节炎，可显着降低活动性，功能性和整体生活质量。痛风来自关节和软组织内尿酸的结晶，引发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..

肾脏在这个过程中起着关键作用，因为它们负责从体内过滤和排泄尿酸。在超过90%的痛风患者中，尿酸排泄不足会导致sUA水平失衡和升高，从而导致尿酸晶体沉积。作为全面痛风治疗和预防策略的一部分，监测和管理sUA水平至关重要。。

About Arthrosi:Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, 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. Gout remains a large and growing market with ~ 13M patients in the U.S.

。痛风仍然是一个巨大且不断增长的市场，在美国约有1300万患者。

alone, ~2M of which have tophaceous 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 2b study. Arthrosi is currently advancing AR882 in a pivotal phase 3 program..

单独使用，其中约200万患有痛风性痛风。与SOC相比，AR882在2期研究中表现出令人鼓舞的疗效和安全性，并且在2b期研究中实现了tophi的完全消退，取得了令人印象深刻的结果。Arthrosi目前正在关键的3期项目中推进AR882。。

Media Contact:Shunqi Yan, PhDFounder & Chief Operating Officershunqi.yan@arthrosi.com

媒体联系人：严顺琦博士创始人兼首席运营官Officershunqi.yan@arthrosi.com

Investor Contact:Precision AQAlex Lobo212-698-8802alex.lobo@precisionaq.com

投资者联系人：Precision AQAlexLobo212-698-8802alex.lobo@precisionaq.com

SOURCE Arthrosi Therapeutics

来源Arthrosi Therapeutics