Kidney Week

Abstract: TH-PO1187

Preliminary Phase 2 Results of APX-115, a Pan-NOX Inhibitor in Patients with CKD Undergoing Percutaneous Coronary Intervention for Contrast-Induced AKI

Session Information

• Late-Breaking Research Posters
  November 06, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Acute Kidney Injury

• 102 AKI: Clinical, Outcomes, and Trials

Authors

• Gwon, Hyeon-Cheol, Samsung Medical Center, Gangnam-gu, Seoul, Korea (the Republic of)

Hyeon-Cheol Gwon, MD, PhD

• Cha, Dae R., Korea University Ansan Hospital, Ansan-si, Gyeonggi-do, Korea (the Republic of)

Dae R. Cha, MD

• Moon, Sung Hwan, AptaBio Therapeutics Inc, Yongin-si, Gyeonggi-do, Korea (the Republic of)

Sung Hwan Moon, PhD

• Lee, Soo Jin, AptaBio Therapeutics Inc, Yongin-si, Gyeonggi-do, Korea (the Republic of)

Soo Jin Lee, PhD

• Shin, Hyesung, AptaBio Therapeutics Inc, Yongin-si, Gyeonggi-do, Korea (the Republic of)

Hyesung Shin

Background

Patients with chronic kidney disease (CKD) undergoing Percutaneous Coronary Intervention (PCI) are at high risk for contrast-induced acute kidney injury (CI-AKI), which increases morbidity and mortality. Current therapeutic options are limited, and APX-115, a pan-NOX inhibitor, targets oxidative stress, a key factor in CI-AKI pathophysiology, and represents a novel therapeutic approach with potential to improve outcomes in this high-risk population.

Methods

This Phase 2, randomized, double-blind, placebo-controlled study evaluates the safety, tolerability, and efficacy of APX-115 in CKD patients (eGFR 30-90 mL/min/1.73m²) undergoing PCI.
Patients were randomized 1:1 to receive either APX-115 400 mg once daily or placebo, starting 48 hours pre-PCI and continuing 2 days post-PCI. A sentinel cohort of 30 patients was completed, followed by an ongoing expansion cohort of 170 patients after Data Monitoring Committee review.
Assessments were performed at 24, 48 hours, and 4 and 12 weeks. The primary endpoint is safety, with secondary endpoints assessing incidence of CI-AKI, changes in kidney function (creatinine, eGFR), pharmacokinetics (PK), and biomarkers. (NCT05758896)

Results

This preliminary analysis included data from a sentinel cohort of 30 evaluable patients (mean age 72 years, baseline eGFR 67.24 mL/min/1.73m²). APX-115 was safe and well-tolerated, with no unexpected safety concerns. Treatment-emergent adverse events were comparable across study groups.
PK analysis demonstrated minimal renal clearance and a stable PK profile in CKD patients.
At 48 hours post-PCI, 26.7% of patients overall developed creatinine elevations (>1.2 mg/dL). Among these patients, exploratory analyses suggested a potential protective effect of APX-115 against long-term kidney function decline. The creatinine elevation at 48 hours was significantly predictive of subsequent eGFR decline at 12 weeks (p = 0.025).

Conclusion

These preliminary results from the sentinel cohort suggest that APX-115 is safe and well-tolerated, with a stable PK profile in CKD patients undergoing PCI. The ongoing expansion cohort, with data expected in early 2026, will provide further evidence on the potential of APX-115 to prevent long-term kidney function decline in CI-AKI.

Funding

• Commercial Support – Aptabio Therapeutics Inc.

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.2025q1nvwna8