Speaker: Isuzinaxib effective in patients with CKD, type 2 diabetes
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ORLANDO — Isuzinaxib, a pan-NOX inhibitor modulating oxidative stress by Aptabio significantly reduced urine albumin-to-creatinine ratio in patients with type 2 diabetes and chronic kidney disease, according to data at ASN Kidney Week.
“Oxidative stress plays an important role in the initiation and progression of kidney disease,” Dae Ryong Cha, MD, PhD, of the Korea University College of Medicine, said in a press conference.
In this phase 2 trial, researchers randomized 140 patients with type 2 diabetes and CKD to either isuzinaxib, also known as APX-115, at 400 mg or placebo for 12 weeks orally. Patients had a urine albumin-to-creatinine ratio (UACR) of 200 mg/g to 3,000 mg/g at baseline, and researchers considered a change in UACR the primary outcome of the study.
At week 12, analyses revealed the mean change of UACR among the isuzinaxib group was
–21% and was –2.5% in the placebo group. While researchers observed a 36% reduction in eGFR at week 12 in the isuzinaxib group, they identified an 11% increase in the placebo group. Also, patients in the isuzinaxib group experienced a significant reduction of kidney injury molecule-1.
Overall, patients with CKD stage 3b experienced an UACR difference of –47% in the isuzinaxib group compared with the placebo group.
“In conclusion, this study demonstrates the first clinical evidence of isuzinaxib’s effectiveness in patients with type 2 diabetes,” Cha said. “In the future, clinical development may be more focused on patients with advanced chronic kidney disease.”
References:
Aptabio to present results of isuzinaxib phase 2 study at the American Society of Nephrology (ASN)'s Kidney Week 2022. https://www.prnewswire.com/news-releases/aptabio-to-present-results-of-isuzinaxib-phase-2-study-at-the-american-society-of-nephrology-asns-kidney-week-2022-301667016.html. Published Nov. 4, 2022. Accessed Nov. 8, 2022.
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Cha DR, et al. FR-OR62. Presented at: ASN Kidney Week; Nov. 3-6, 2022; Orlando (hybrid meeting).
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