Aptabio Receives US FDA Approval for Phase 2 Clinical Trial Plan of Contrast-Induced Acute Kidney Injury Treatment

[Asia Economy Reporter Jang Hyowon] Aptabio, a developer of refractory anticancer drugs and diabetic complication treatments (CEO Sujin Lee), announced on the 10th that it has received approval from the US FDA for the Phase 2 clinical trial plan (IND) of the contrast agent-induced acute kidney injury treatment ‘Aisujinaxib (APX-115)’.

Previously, in May last year, Aptabio applied to the US FDA for the Phase 2 clinical trial plan (IND) of ‘Aisujinaxib (APX-115)’, a treatment for contrast agent-induced acute kidney injury under research. Following the approval of this Phase 2 clinical trial plan, Aptabio plans to evaluate the safety and efficacy of ‘Aisujinaxib (APX-115)’ for contrast agent-induced acute kidney injury in patients undergoing cardiovascular interventional procedures.

Contrast-induced acute kidney injury (CI-AKI) is a condition where kidney function acutely deteriorates after administration of a contrast agent (a drug administered to the body to make certain tissues or blood vessels more visible during examinations or procedures). During cardiovascular interventional procedures (such as renal stent insertion), the incidence of complications and mortality related to contrast agent-induced acute kidney injury is increasing.

Despite extensive research on treatments for this condition, no approved therapies currently exist, representing a significant unmet medical need. Considering this situation, Aptabio plans to apply for the US FDA Fast Track designation for ‘Aisujinaxib (APX-115)’.

An Aptabio representative stated, “The clinical study for the indication of contrast agent-induced acute kidney injury with Aisujinaxib will proceed positively based on the safety and efficacy results obtained from the Phase 2 clinical trial for diabetic nephropathy.” He added, “We expect that Aisujinaxib can become a new treatment option for contrast agent-induced acute kidney injury, a disease currently without treatment.”