—     Continued treatment with AR882 demonstrated safe, efficacious and sustained reduction in sUA at 12 months —

-AR882的持续治疗表明，在12个月时sUA安全，有效且持续降低-

—     AR882 achieved deep and durable tophus and crystal volume dissolution at 12 months —

-AR882在12个月时实现了深度持久的痛风石和晶体体积溶解-

SAN DIEGO, June 14, 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 new positive clinical data from its phase 2 AR882-203 study in patients with tophaceous gout.

圣地亚哥，2024年6月14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，今天宣布了痛风患者第二阶段AR882-203研究的新阳性临床数据。

These data are being presented as poster presentations at the European Alliance of Associations for Rheumatology (EULAR) 2024 European Congress of Rheumatology, being held June 12-15 in Vienna, Austria..

这些数据将作为海报展示在6月12日至15日在奥地利维也纳举行的欧洲风湿病协会联盟（EULAR）2024年欧洲风湿病大会上。。

'We are excited to share new data from our Phase 2 trial of AR882 highlighting its long-term durability of effect and strong safety profile, further building on the body of evidence supporting AR882 as a potentially best-in-class treatment for patients with gout,' said Arthrosi's Chief Medical Officer Robert T.

Arthrosi首席医疗官Robert T.说：“我们很高兴分享AR882第二阶段试验的新数据，突出了其长期持久的疗效和强大的安全性，进一步巩固了支持AR882作为痛风患者潜在最佳治疗方法的证据。”。

Keenan, MD, MPH, MBA. 'There remains a significant unmet need for patients with tophaceous gout, a disease marked by chronic pain and significantly diminished functionality. This new 12-month data reinforce the promising findings from the initial 6-month treatment period of the Phase 2 trial, demonstrating safe and robust SUA lowering as well as deeper and durable tophus and crystal volume dissolution at 12 months.

医学博士基南（Keenan），公共卫生硕士（MPH），工商管理硕士（MBA）痛风患者的需求仍然没有得到满足，痛风是一种以慢性疼痛和功能明显减弱为特征的疾病。这项为期12个月的新数据强化了2期试验最初6个月治疗期的有希望的发现，证明了在12个月时安全可靠的SUA降低以及更深持久的痛风石和晶体体积溶解。

Based on the favorable therapeutic profile observed to date, we believe AR882 has the potential to reduce debilitating symptoms and significantly improve treatment outcomes for patients with gout. We are currently advancing AR882 in a pivotal Phase 3 program and look forward to initiating the second confirmatory phase 3 study later this year.'.

基于迄今为止观察到的有利治疗概况，我们认为AR882有可能减少使人衰弱的症状，并显着改善痛风患者的治疗效果。我们目前正在关键的第三阶段计划中推进AR882，并期待着在今年晚些时候启动第二个验证性第三阶段研究。”。

New Clinical Data for AR882, Arthrosi's URAT1 Inhibitor

AR882（Arthrosi的URAT1抑制剂）的新临床数据

In a poster tour presentation, Dr. Keenan will highlight new 12-month clinical data from the company's phase 2 trial in patients with chronic gouty arthritis building upon AR882's promising safety and efficacy profile and further validating its durability of response. The phase 2, randomized, open-label, global trial recruited 42 patients with at least one subcutaneous tophus.

在海报巡演中，Keenan博士将重点介绍该公司针对慢性痛风性关节炎患者的2期临床试验的新12个月临床数据，这些数据基于AR882有希望的安全性和有效性，并进一步验证其反应的持久性。第二阶段，随机，开放标签，全球试验招募了42名至少有一个皮下痛风石的患者。

The patients were randomized equally into three treatment groups to receive a once daily dose of AR882 75 mg, AR882 50 mg + allopurinol or allopurinol up to 300 mg. At the end of 6 months, the allopurinol monotherapy group had AR882 75 mg added, while the other two groups continued the same therapy..

患者被随机分为三个治疗组，每天一次服用AR882 75 mg，AR882 50 mg+别嘌呤醇或别嘌呤醇300 mg。在6个月结束时，别嘌呤醇单药治疗组加入AR882 75 mg，而其他两组继续相同的治疗。。

The data showed:

数据显示：

Both the AR882 75 mg and the AR882 50 + allopurinol groups demonstrated a persistent and sustained decrease in sUA throughout the 12 months.

AR882 75 mg和AR882 50+别嘌呤醇组在整个12个月内均显示sUA持续下降。

The average baseline sUA level ranged between 9.1-9.6 mg/dL across groups. At 3 months, median patient sUA levels were reduced to 4.5, 4.7, and 6.1 mg/dL for AR882 75 mg, AR882 50 mg + allopurinol and allopurinol groups, respectively. Notably, at 12 months, sUA levels for all groups further decreased to 3.9, 4.4 mg/dL and 4.0 mg/dL for the AR882 75 mg, AR882 50 mg + allopurinol and AR882 75 mg + allopurinol groups, respectively..

各组的平均基线sUA水平在9.1-9.6 mg/dL之间。在3个月时，AR882 75 mg，AR882 50 mg+别嘌呤醇和别嘌呤醇组的患者sUA中位数分别降至4.5、4.7和6.1 mg/dL。值得注意的是，在12个月时，AR882 75 mg，AR882 50 mg+别嘌呤醇和AR882 75 mg+别嘌呤醇组的所有组的sUA水平分别进一步降至3.9、4.4 mg/dL和4.0 mg/dL。。

During the 6-month extension phase, complete tophus resolution of at least 1 target tophus measured by digital caliper was seen in 35.7% (5/14) for the AR882 75 mg group and 36.4% (4/11) for the AR882 75 mg + allopurinol group.

在6个月的延长期内，AR882 75 mg组的35.7%（5/14）和AR882 75 mg+别嘌呤醇组的36.4%（4/11）观察到通过数字卡尺测量的至少1个目标tophus的完全tophus分辨率。

From baseline to Month 6, AR882 75 mg alone or in combination with allopurinol showed reduction of total urate crystal volume of -7.5 cm3 and -10.6 cm3, respectively. AR882 75 mg as monotherapy was further evaluated through months 6 to 12 and demonstrated a sustained crystal volume reduction of -13.3 cm3.

从基线到第6个月，单独使用AR882 75 mg或与别嘌呤醇联合使用时，尿酸盐晶体总体积分别减少了-7.5 cm3和-10.6 cm3。在6至12个月内进一步评估了AR882 75 mg作为单一疗法，并证明晶体体积持续减少了-13.3 cm3。

In patients with significant baseline crystal volume of ≥5.0 cm3 AR882 75 mg demonstrated a sustained -26.4 cm3 reduction at 12 months..

在基线晶体体积≥5.0 cm3的患者中，AR882 75 mg在12个月时表现出持续的-26.4 cm3减少。。

AR882 was well tolerated throughout 12-month chronic treatment both as a monotherapy and in combination with allopurinol.

AR882作为单一疗法和与别嘌呤醇联合使用，在整个12个月的慢性治疗过程中耐受性良好。

Drug-Drug Interaction Data for AR882

AR882的药物相互作用数据

In a second poster presentation, Litain Yeh, Ph.D., Chief Executive Officer of Arthrosi, will discuss in vitro and clinical data supporting AR882's potential to be safely administered to gout patients with various concomitant medications and comorbid conditions including diabetes, hypertension and hyperlipidemia..

。。

The data show:

数据显示：

In vitro assessments indicated that AR882 exhibited no drug-drug interactions (DDI) with key renal, hepatic and gastrointestinal transporters as substrate or inhibitor at the relevant clinical concentration.

体外评估表明，在相关的临床浓度下，AR882与关键的肾脏，肝脏和胃肠道转运蛋白作为底物或抑制剂没有药物相互作用（DDI）。

AR882 had no inhibitory effect on any transporters except for breast cancer resistance protein (BCRP), which plays an important role in the transport of urate, a key component in gout development.

除乳腺癌耐药蛋白（BCRP）外，AR882对任何转运蛋白均无抑制作用，BCRP在尿酸盐的转运中起重要作用，尿酸盐是痛风发展的关键成分。

Based on these preclinical findings, Arthrosi conducted a clinical DDI study of AR882 as an inhibitor of BCRP. Sulfasalazine, a clinical substrate of BCRP and a commonly used drug in autoimmune and rheumatic diseases, was selected for the study.

基于这些临床前发现，Arthrosi对AR882作为BCRP抑制剂进行了临床DDI研究。柳氮磺吡啶是BCRP的临床底物，也是自身免疫性和风湿性疾病的常用药物，被选为研究对象。

Co-administration of AR882 75 mg with sulfasalazine produced no clinically relevant alterations in the pharmacokinetics (Cmax and AUC) of sulfasalazine, suggesting no clinically significant BCRP-mediated DDI.

AR882 75 mg与柳氮磺吡啶的共同给药对柳氮磺吡啶的药代动力学（Cmax和AUC）没有产生临床相关的改变，表明没有临床上显着的BCRP介导的DDI。

Details for the poster presentations are as follows:

海报演示的详细信息如下：

Title: AR882, a Novel and Selective URAT1 Inhibitor, Significantly Reduced Tophi in Patients with Chronic Gouty Arthritis: Results of 12-month Outcome from a Global Trial using Digital Caliper Measurements and Dual Energy Computed TomographySession Title: Clinical Poster Tours: Gout treatment in 2024Presenting Author: Robert Keenan, M.D., Chief Medical Officer of Arthrosi TherapeuticsAbstract Number: POS0268Date/Time: Friday, June 14 / 9:30am-10:30am CEST.

标题：AR882是一种新型选择性URAT1抑制剂，可显着降低慢性痛风性关节炎患者的痛风石：使用数字卡尺测量和双能计算机断层扫描进行的全球试验的12个月结果标题：临床海报巡演：2024年痛风治疗目前的作者：Robert Keenan，M.D.，Arthrosi Therapeutics首席医疗官stract编号：POS0268日期/时间：6月14日星期五/9:30am-10:30am CEST。

Title: AR882, a Selective URAT1 Inhibitor, Exhibits No Drug-Drug Interactions with Key Renal, Hepatic, and GI TransportersPresenting Author: Litain Yeh, Ph.D, Co-Founder and Chief Executive Officer of Arthrosi TherapeuticsAbstract Number: POS0935Date/Time: Friday, June 14 / 9:30am-10:30am CEST

Both poster presentations will be available in the 'Publications' section of Arthrosi's website: https://arthrosi.com/publications/.

这两张海报都将在Arthrosi网站的“出版物”部分提供：https://arthrosi.com/publications/.

About the AR882-203 Phase 2 StudyThe Phase 2 study of AR882 in patients with tophaceous gout was a six-month, 1:1:1 randomized, global, placebo-controlled study of 42 patients with subcutaneous tophi. The mean baseline sUA among the participants ranged between 9.1-9.6 mg/dL. In the study, patients received a once daily dose of either 75 mg AR882, 50mg AR882 + allopurinol, or allopurinol up to 300mg.

关于AR882-203 2期研究AR882在痛风性痛风患者中的2期研究是一项为期6个月，1:1:1的随机，全球，安慰剂对照研究，对42例皮下痛风石患者进行了研究。参与者的平均基线sUA介于9.1-9.6 mg/dL之间。。

Serum uric acid levels (< 6, <5, <4, or <3 mg/dL) were evaluated monthly through month 6, and safety and tolerability were assessed throughout the study. Tophi measurements with calipers were completed every 4 weeks for 6 months. Patients were also imaged using Dual-Energy Computed Tomography (DECT), DECT a specialized imaging technique that is able to differentiate and identify uric acid crystals in the joints and soft tissue, allowing for quantifying uric acid crystals and tophi at baseline and 6 months.

每月至第6个月评估血清尿酸水平（<6，<5，<4或<3 mg/dL），并在整个研究过程中评估安全性和耐受性。用卡尺测量Tophi每4周完成一次，持续6个月。还使用双能计算机断层扫描（DECT）对患者进行了成像，DECT是一种专门的成像技术，能够区分和识别关节和软组织中的尿酸晶体，从而可以在基线和6个月时定量尿酸晶体和痛风石。

The primary efficacy endpoint was sUA change at 3 months. Secondary endpoints included complete resolution of at least one target tophus with no new tophi and no tophus showing progression. Safety assessments, including vital signs and electrocardiograms, were collected throughout the study. The trial also included a 6-month extension period designed to evaluate longer-term patient outcomes..

主要疗效终点是3个月时sUA的变化。次要终点包括至少一个目标痛风石的完全消退，没有新的痛风石，也没有痛风石显示进展。在整个研究过程中收集了安全性评估，包括生命体征和心电图。该试验还包括为期6个月的延长期，旨在评估患者的长期预后。。

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水平不平衡和升高，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:

关于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.

总部位于加利福尼亚州圣地亚哥的Arthrosi Therapeutics，Inc.专注于开发AR882，这是一种潜在的同类最佳，高效和选择性的下一代URAT1抑制剂，可降低痛风患者的血清尿酸盐水平，耀斑和痛风石。。

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 anticipates initiating pivotal phase 3 program in early 2024..

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预计在2024年初启动关键的第三阶段计划。。

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

媒体联系人：严顺琦，PHD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