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Atom Bioscience在美国招募患者,作为一种新的慢性痛风研究性治疗方法的全球2b/3期临床试验的一部分

Atom Bioscience Enrolling Patients in US as Part of a Global Phase 2b/3 Clinical Trial of a New Investigational Treatment for Chronic Gout

businesswire 等信源发布 2024-04-24 15:30

可切换为仅中文


JIANGSU, China--(BUSINESS WIRE)--Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing new treatments for inflammatory and metabolic diseases, has begun enrolling patients in the US for in a Phase 2b/3 clinical trial of ABP-671, a novel investigational orally administered URAT1 inhibitor, for the treatment of chronic gout.

中国江苏——(商业新闻短讯)——Atom Bioscience(江苏Atom Bioscience and Pharmaceutical Co.,Ltd.)是一家开发炎症和代谢疾病新疗法的临床阶段生物技术公司,已开始在美国招募患者,用于治疗慢性痛风的新型研究性口服URAT1抑制剂ABP-671的2b/3期临床试验。

Currently 36 sites have been identified in 17 states..

目前,已在17个州确定了36个地点。。

The multicenter, randomized, double-blind trial will enroll 580 patients worldwide. For locations of U.S. trial sites and contacts visit clinicaltrials.gov; (NCT05818085). Part 1 of the trial will evaluate the safety and efficacy of ABP-671 at different doses and regimens compared with either placebo or allopurinol, the current standard of care for management of gout in the U.S.

这项多中心、随机、双盲试验将在全球招募580名患者。有关美国试验地点和联系人的位置,请访问clinicaltrials.gov;(NCT05818085)。该试验的第一部分将评估ABP-671在不同剂量和方案下与安慰剂或别嘌呤醇(美国目前治疗痛风的标准)相比的安全性和有效性。

Part 2 of the study will compare dosing regimens of ABP-671 selected from Part 1 with placebo in patients not enrolled in Part 1..

该研究的第2部分将比较从第1部分中选择的ABP-671的给药方案与未参加第1部分的患者的安慰剂。。

Gout is one of the most common types of inflammatory arthritis. It is caused by long-term hyperuricemia, an excessive concentration of serum uric acid (sUA) greater than 7 mg/dL (420 μmol/L). Gout seriously affects people's quality of life and can increase the probability of sudden cardiac death. Existing drugs for treating chronic gout have poor efficacy and pose serious safety issues, such as leading to kidney failure, sudden cardiac death, or severe liver toxicity..

痛风是最常见的炎性关节炎之一。它是由长期高尿酸血症引起的,血尿酸(sUA)浓度过高,超过7 mg/dL(420μmol/L)。痛风严重影响人们的生活质量,并可能增加心脏猝死的可能性。现有治疗慢性痛风的药物疗效不佳,并带来严重的安全问题,例如导致肾衰竭,心源性猝死或严重的肝毒性。。

About Atom Bioscience

关于原子生物科学

Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd.) is a fast-growing innovative drug company, focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, ABP-671, is in clinical development for treatment of chronic gout.

Atom Bioscience(江苏Atom Bioscience and Pharmaceutical Co.Ltd.)是一家快速发展的创新药物公司,专注于开发用于治疗炎症和代谢疾病的一流小分子疗法。该公司的主导产品ABP-671正在临床开发中,用于治疗慢性痛风。

Another small molecule ABP-745 has shown significant efficacy and good safety in animal models of anti-inflammation, and is in a phase 1 clinical trial, For more information, please visit: https://www.atombp.com or atombp.us..

另一种小分子ABP-745在抗炎动物模型中显示出显着的功效和良好的安全性,并且正在进行1期临床试验,有关更多信息,请访问:https://www.atombp.com或者美国。。