圣地亚哥，2022年8月9日——Arthrosi Therapeutics , Inc .，由维亚生物参与投资孵化的，一家专注于痛风治疗的临床阶段生物技术公司，今天宣布其主打管线AR882完成了肾功能损害的临床研究。AR882是一种强效和选择性的尿酸排泄剂，在肾功能正常的患者以及轻度至重度肾功能不全的患者中表现出显著的降低血清尿酸的效果。
Arthrosi首席执行官叶立天博士表示：“本次对AR882肾功能损害的临床试验中，我们纳入了肾功能正常、轻度、中度和重度肾功能损害的受试者，其中包括一部分有蛋白尿症状（慢性肾病CKD的一种临床表现）的II型糖尿病患者。临床观察和研究数据显示，AR882对包括II型糖尿病患者在内的不同程度肾功能损害的患者表现出良好的有效性和耐受性。”
关于Arthrosi Therapeutics
Arthrosi Therapeutics是一家2018年位于加利福尼亚州的临床阶段生物医药公司，致力于研究口服的、同类最佳痛风药物，以降低痛风患者的尿酸水平并减少其关节损伤。Arthrosi团队利用丰富的专业知识，开发创新治疗方法，积累了强大的知识产权和令人印象深刻的临床一期和二期数据，以帮助数百万痛风患者。此外，Arthrosi还拥有肿瘤治疗药物的管线。欲了解更多Arthrosi信息，请访问www.arthrosi.com
原文阅读如下：
Arthrosi Completes AR882 Renal Impairment Study
SAN DIEGO, Aug. 9, 2022 -- Arthrosi Therapeutics, Inc., which invested and incubated by Viva BioInnovator, a clinical-stage biotechnology company focused on treatment for the management of gout, today announced the completion of its renal impairment study utilizing the lead compound, AR882. AR882 is a potent and selective uricosuric agent, which has shown effectiveness lowering serum urate in patients with normal renal function, and in patients with mild to severe renal impairment.
"We have conducted the renal impairment study to include subjects with normal renal function, mild, moderate, and severe renal impairment and a subset of type 2 diabetes patients with albuminuria, which is a clinical manifestation of chronic kidney disease (CKD). The data demonstrated that AR882 is potent and well-tolerated for patients with various degrees of renal impairment, including patients with type 2 diabetes," said Arthrosi CEO Litain Yeh.
The Study
AR882 was administered as a 100 mg single oral dose to subjects with normal renal function (n=8), mild renal impairment (n=8), moderate renal impairment (n=8), and severe renal impairment (n=6). In a separate cohort, an additional 16 subjects were enrolled to evaluate multiple once-daily doses of AR882 at 75 mg in subjects with type 2 diabetes and microalbuminuria (urine albumin/creatinine ratio between 30-300 mg/g, n=6) versus normal healthy subjects (n=10).
In subjects with various renal functions, similar exposure (Cmax and AUC) was seen compared to patients with normal renal function. Mean serum urate levels (sUA) were reduced between 50 to 60 percent, regardless of mild or moderate impairment, or normal renal function. In subjects with severe renal impairment, as expected, the sUA reduction was seen at lesser degrees, consistent with reduced excretion of drug levels in the urine.
In type 2 diabetes patients with microalbuminuria, an early sign of kidney disease, preliminary data shows reduction in Uric Acid-to-Creatinine Ratio (UACR) from screening or baseline following dosing. AR882 was well-tolerated in renally impaired subjects, showing a similar safety profile to that observed in healthy volunteer studies.
"We are pleased to see similar efficacy and levels of AR882 in patients with chronic kidney disease. The results suggest that no dose adjustment will likely be needed in patients with various degrees of renal function. The UACR lowering effect of AR882 in type 2 diabetes patients with impaired kidney function, though in small sample size, suggests AR882 could be a promising new option for treatment of CKD patients with hyperuricemia but will need further validation," said Arthrosi's Chief Medical Officer Dr. Robert T. Keenan.
About Arthrosi
Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase I and Phase II data showing industry leading efficacy rates and superior safety profiles. To learn more about Arthrosi, please visit www.arthrosi.com
