[Edaily Reporter NA EUN-KYUNG ] DB Securities assessed that the prospects for a global technology export have increased for “Isuzinaxib” (APX115), a kidney disease treatment developed by Aptabio Therapeutics Inc.(293780), after it demonstrated significant improvements in renal function in a Phase 2 clinical trial for contrast-induced acute kidney injury (CI-AKI).

Lee Myung-sun, an analyst at DB Securities, stated on the 27th in a report titled “Announcement of APX115 Phase 2 Clinical Trial Results Meeting Even the Revised KDIGO Criteria” that “if effective results are also demonstrated in chronic diabetic nephropathy (DKD) following acute kidney injury, we can expect a meaningful technology licensing agreement.”

Aptabio Therapeutics Inc. presented the efficacy results of the Phase 2 clinical trial of Isuzinacxib for contrast-induced acute kidney injury at the American Society of Nephrology (ASN 2026) conference held from the 21st to the 25th. Isuzinacxib is an oral drug candidate that reduces oxidative stress and inflammation—which cause kidney damage—by inhibiting NADPH oxidase (NOX), an enzyme involved in the production of reactive oxygen species.

This clinical trial was conducted at 14 hospitals in South Korea and the United States, involving 212 patients scheduled to undergo coronary intervention. The drug was administered for a total of five days, starting two days before the procedure and continuing through the post-procedure period, and changes in renal function were evaluated at the 12-week mark.

As a result, the estimated glomerular filtration rate (eGFR), a measure of kidney function, decreased by 1.8% in the treatment group, compared to a 7.4% decrease in the placebo group. The difference between the two groups was 5.6 percentage points, which was statistically significant (p=0.017). The increase in serum creatinine also showed a significant difference, with 0.03 DL in the treatment group and 0.10 DL in the placebo group (p=0.028).

In particular, among high-risk patients with a baseline eGFR below 60, the rate of eGFR decline at 12 weeks was 0.9% in the treatment group and 9.7% in the placebo group. Although the incidence of acute kidney injury immediately following contrast agent administration was similar in both groups, the incidence of acute kidney disease (AKD)—characterized by persistent renal dysfunction—was observed to be approximately half as high in the treatment group as in the placebo group.

The researcher noted that these findings align with the 2026 revised guidelines on acute kidney injury from KDIGO, the organization responsible for developing international kidney disease treatment guidelines. The revised guidelines place significant emphasis on the extent of renal function recovery not only immediately following acute injury but also up to 90 days afterward.

He commented, “While previous clinical trials on acute kidney injury primarily assessed whether injury occurred within 48 to 72 hours after the procedure, this trial confirmed improvements in renal function up to the 12-week mark,” adding, “Its clinical value has increased as it demonstrates the potential for this treatment to reduce the risk of progression to chronic kidney disease.”

Aptabio Therapeutics Inc. plans to secure the final Clinical Study Report (CSR) for this Phase 2 clinical trial in the first half of next year and apply for Fast Track designation from the U.S. Food and Drug Administration (FDA).

Progress in the development of treatments for diabetic nephropathy was also cited as a key factor for future technology exports. Although Aptabio Therapeutics Inc. did not achieve statistical significance in improving the urine albumin-to-creatinine ratio (UACR) across the entire patient population in its 2022 European Phase 2a clinical trial, it did observe signs of improvement in a subset of patients with significantly impaired kidney function.

Based on these findings, the company is currently conducting a Phase 2b clinical trial in South Korea involving 147 patients with moderate-to-severe diabetic nephropathy, with the goal of securing topline results in the second half of next year.

The researcher noted, “If we can confirm the drug’s potential for both prevention and treatment of acute and chronic kidney injury, interest from global pharmaceutical companies will increase,” highlighting the potential for technology export based on the clinical outcomes for these two indications.