Arthrosi Therapeutics, Inc., 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.
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.
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 1 and Phase 2 data showing industry leading efficacy rates and superior safety profiles.
Shunqi Yan, PhD
Founder & Chief Operating Officer
SOURCE Arthrosi Therapeutics