[Edaily Reporter KIM JI-WAN ] Aptabio Therapeutics Inc.(293780)has met the primary endpoint in the global Phase 2 clinical trial of “Isuzinacxib” (APX-115), which is being developed as a treatment for contrast-induced acute kidney injury (CI-AKI). While no significant safety concerns were identified, key efficacy data to assess the treatment’s effectiveness are scheduled to be released in the U.S. on the 23rd of this month.

Aptabio Therapeutics Inc. announced on the 15th that it has completed the safety evaluation—the primary endpoint—in the Phase 2 clinical trial of APX-115 conducted in South Korea and the United States. A comprehensive analysis of adverse events, physical examinations, electrocardiograms, and clinical laboratory tests revealed no clinically significant differences between the APX-115 treatment group and the placebo group.

This clinical trial was designed to enroll 160 patients undergoing percutaneous coronary intervention (PCI) at 14 medical institutions in South Korea and the United States. It was conducted as a randomized, double-blind, placebo-controlled study, with the objective of confirming the safety and therapeutic potential of the drug candidate through a proof-of-concept (PoC) study.

In particular, the company explained that no notable safety issues were observed even in the high-risk patient group with impaired renal function. An analysis of patients with an estimated glomerular filtration rate (eGFR) of 45 mL/min/1.73 m² or lower also revealed no clinically concerning adverse findings.

However, efficacy results to determine the actual effectiveness in preventing kidney damage have not yet been disclosed. Aptabio Therapeutics Inc. plans to present the analysis results for key secondary endpoints at the American Society of Nephrology (ASN) “Kidney Week 2026,” taking place on the 23rd (local time) in Denver, Colorado.

This study was selected for an oral presentation in the “Late-Breaking” session at the conference. Professor Kwon Hyun-cheol of the Department of Cardiology at Samsung Seoul Hospital will deliver the presentation.

According to the company, this year’s Late-Breaking Clinical Trials program includes a total of 99 studies, comprising both oral and poster presentations. Of these, 32 are oral presentations, and three are Phase 2 clinical trials for therapeutic agents. Isuzinacxib is one of those three.

A separate study examining the potential for long-term kidney protection will also be presented. Aptabio Therapeutics Inc. will present the results of its “AKI-to-AKD Continuum” analysis—which tracked changes in kidney function up to 12 weeks after the onset of acute kidney injury—in a poster presentation. This study expanded the evaluation scope beyond the traditional focus on changes in serum creatinine levels within 48 hours to examine long-term renal protective effects. The company expects to utilize these findings in designing endpoints for future Phase 3 clinical trials.

This is not the first time Aptabio has presented data on ISUZINACXIV at ASN. Last year at Kidney Week 2025, data from the Sentinel Cohort was also selected for presentation as part of the late-stage clinical trial program. As a result, the company has been featured in this program for two consecutive years.

Previously, in 2022, clinical results for the diabetic kidney disease (DKD) indication were selected for an oral presentation in the “High-Impact Clinical Trials (HICT)” session at the same conference. Aptabio Therapeutics Inc. is broadening the development scope of Isuzinacxib by accumulating clinical data across different kidney disease indications.

Discussions regarding technology transfer aimed at commercialization are also ongoing. Aptabio Therapeutics Inc. plans to secure the final clinical study report (CSR) for this clinical trial by the first half of 2027. Separately, the company is currently conducting technology transfer negotiations with multiple global pharmaceutical companies.

The company is also exploring various negotiation structures. In addition to individual technology transfer agreements targeting only the CI-AKI indication, package deals that include the DKD indication are also under discussion. The company plans to finalize these negotiations based on the results of this safety evaluation and the efficacy data to be released this month.

Lee Soo-jin, CEO of Aptabio Therapeutics Inc., stated, “Following the confirmation of safety—our primary endpoint—being selected for ASN Late-Breaking for two consecutive years and having our study accepted for an oral presentation this year signifies that the clinical value of ‘Isuzinacxiv’ is gaining international recognition.” She added, “We will accelerate technology transfer discussions based on these topline results. “Since safety has now been confirmed in a therapeutic area where no approved treatments currently exist, we expect discussions with potential partners to move to a more concrete stage,” she added.

Contrast-induced acute kidney injury (CI-AKI) refers to a decline in kidney function that can occur following the administration of contrast agents used in procedures such as coronary interventions. This complication requires particular caution in patients with pre-existing kidney disease or impaired kidney function.

Currently, there are no drugs approved specifically for the treatment of CI-AKI. If Isuzinacxib demonstrates efficacy and safety in subsequent clinical trials and obtains approval, it has the potential to establish itself as a first-in-class treatment with a novel mechanism of action.