[Edaily Reporter NA EUN-KYUNG ] Aptabio Therapeutics Inc.(293780)announced on the 23rd that it has completed follow-up observations for the final patient in the global Phase 2 clinical trial of “Isuzinacxiv” (APX-115), a treatment for contrast-induced acute kidney injury (CI-AKI).

Following the completion of dosing for the last patient in April, the company has now finished the 12-week follow-up period and has entered the final data analysis phase. Topline results are scheduled to be released in the second half of the year.

This clinical trial was a randomized, double-blind, placebo-controlled study conducted in South Korea and the United States involving patients undergoing percutaneous coronary intervention (PCI), with a total of 159 participants.

Previously, the Data Monitoring Committee (DMC) reviewed data from the initial patient group (Sentinel Cohort) and recommended expanding the trial. The results of the subsequent analysis of this data were presented last year at the Late-Stage Clinical Trials (LBCT) session of the American Society of Nephrology (ASN) “Kidney Week 2025.”

Aptabio Therapeutics Inc. plans to secure topline results by the end of the third quarter or early in the fourth quarter and receive the Clinical Study Report (CSR) by the end of the year. The company is currently in discussions with global pharmaceutical companies regarding technology transfer and plans to intensify negotiations once the topline results are available.

Isuzinacxib is being developed not only for contrast-induced acute kidney injury but also for diabetic kidney disease (DKD). A Phase 2b clinical trial for DKD is currently underway in South Korea, and the candidate is designed to target both acute kidney injury and chronic kidney disease based on the same pan-NOX inhibition mechanism.

According to the company, contrast-induced acute kidney injury occurs in approximately 10% of patients undergoing PCI procedures, and the incidence rate rises to over 30% in patients with pre-existing kidney disease; however, there are currently no approved treatments.

Lee Soo-jin, CEO of Aptabio Therapeutics Inc., stated, “Now that we have completed both dosing and follow-up in the global clinical trial, we are focusing our efforts on deriving top-line results,” adding, “We expect that the technology transfer discussions currently underway with global pharmaceutical companies will become more concrete following the release of the top-line results.”