Aptabio Applies for IND for Phase 2 Clinical Trial of 'Contrast Agent-Induced Acute Kidney Injury Treatment' with US FDA

[Asia Economy Reporter Lee Gwan-joo] Aptabio announced on the 2nd that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial of 'Aisujinaxib (APX-115),' a treatment for contrast-induced acute kidney injury.

Aptabio plans to verify the safety and efficacy of Aisujinaxib in 290 patients undergoing cardiovascular interventional procedures.

Contrast-induced acute kidney injury (CI-AKI) is a condition in which kidney function acutely deteriorates after administration of contrast agents, and it is the main cause of hospital-acquired acute kidney injury induced by contrast use during radiological examinations.

Various mechanisms may be involved in the onset of CI-AKI, and although the exact mechanism by which contrast agents cause kidney damage has not been elucidated, ischemic injury due to reduced renal blood flow and direct tubular cell damage caused by contrast agents are presumed to be the main mechanisms.

In animal models of contrast-induced acute kidney injury, Aisujinaxib demonstrated improvements in blood BUN (Blood urea nitrogen) and creatinine levels, reduction of kidney injury markers, improvement of tubular damage, reduction of inflammation in kidney tissue, decreased infiltration of inflammatory cells in kidney tissue, and reduction of oxidative stress.

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