[Edaily Reporter KIM JI-WAN ] Aptabio Therapeutics Inc.(293780)has expressed confidence ahead of the announcement of the efficacy of its kidney disease treatment candidate “Isuzinaxib” (APX-115). This follows the company’s selection for an oral presentation at the American Society of Nephrology (ASN) conference, with the company indicating that it has secured positive results in certain efficacy metrics.

According to Aptabio Therapeutics Inc. on the 20th, the company will present efficacy data from the global Phase 2 clinical trial of Isuzinaxib for contrast-induced acute kidney injury (CI-AKI) at the American Society of Nephrology (ASN) meeting in Denver, USA, on the 23rd (local time). Professor Kwon Hyun-cheol of the Department of Cardiology at Samsung Seoul Hospital will deliver the presentation. This clinical trial enrolled 160 patients undergoing percutaneous coronary intervention (PCI) at 14 medical institutions in South Korea and the United States.

Previously, on the 15th, Aptabio Therapeutics Inc. announced that it had met the primary endpoint of safety for the Phase 2 clinical trial. The company explained that there were no clinically significant differences in safety when comparing the treatment group to the placebo group.

Contrast-induced acute kidney injury is a complication in which kidney function rapidly declines due to contrast agents used in angiography or PCI. As the kidneys fail to properly filter waste products, serum creatinine levels rise. Particular caution is required for patients with pre-existing kidney disease or impaired kidney function.

“There are indicators showing results in the desired direction”… Confidence in selection for oral presentation

The key focus of this presentation is efficacy. The major secondary endpoints to be disclosed at this conference serve as the basis for that assessment.

An Aptabio Therapeutics Inc. representative expressed confidence, stating, “There are metrics that point in the direction we want,” and added, “In particular, we met the p-value criteria, which the market considers crucial.”

Isuzinacxib regulates oxidase (NOX). After contrast agent administration, reactive oxygen species (ROS) are excessively produced in renal tubular cells. This leads to increased oxidative stress, resulting in cellular damage and impaired renal function. Isuzinacxib inhibits the production of reactive oxygen species, thereby reducing renal damage before and after contrast agent administration.

He also explained in detail the reason for disclosing efficacy data at the conference.

He explained, “Under the current system, only primary endpoints are required to be disclosed,” adding, “For secondary endpoints, including efficacy data, disclosure is permitted only after receiving the Clinical Study Report (CSR). However, if the data is presented at a scientific conference, the results can be made public afterward.”

Another reason the company is showing confidence is the format of the presentation.

He emphasized, “The Isuzinacxib study was selected for an oral presentation on late-stage clinical trials at this conference,” adding, “The competition for oral presentations was quite fierce. The fact that Isuzinacxib was selected for an oral presentation indicates that the results were strong and significant.”

This suggests that the Phase 2 clinical trial of Isuzinacxive actually succeeded in reducing kidney damage and protecting kidney function.

A total of 99 studies—including both oral and poster presentations—will be presented at this conference. Of these, 32 are oral presentations. Among them, only three are Phase 2 clinical trial presentations, including that on Aisuzinacxib.

What is fueling expectations is that the efficacy data from this Phase 2 clinical trial also examined changes in kidney function beyond the acute phase. Aptabio Therapeutics Inc. will present a separate poster analyzing data tracked up to 12 weeks after the onset of acute kidney injury. This approach aims to examine not only changes in kidney function immediately following contrast agent administration but also the subsequent recovery process.

Technology Transfer Discussions Gain Momentum

Market potential is also drawing attention. CI-AKI is an area closely linked to the millions of PCI procedures performed globally each year. According to industry sources, the incidence of acute kidney injury following PCI is known to be approximately 10–15%, and it can exceed 30% in high-risk groups.

According to Boston Scientific, a global medical device company, approximately 6 million people worldwide undergo percutaneous coronary intervention (PCI) each year. A meta-analysis of over 1.21 million patients published in the *Journal of Nephrology* found that the incidence of contrast-induced acute kidney injury (CI-AKI) among PCI patients was 13.3%.

Following the release of this efficacy data, significant progress is expected in technology transfer discussions.

Aptabio Therapeutics Inc. stated, “We have been in discussions with major global pharmaceutical companies, but there were limitations in finalizing agreements prior to the release of the efficacy data,” adding, “With this announcement, potential partners can now review the actual results.” The company further noted, “Aptabio Therapeutics Inc. plans to focus on follow-up discussions through events such as BioEurope and the J.P. Morgan Healthcare Conference.”

“A technology transfer would be ideal, but developing a Phase 3 trial with a partner is also an option,” the company representative said. “This Phase 2 clinical trial confirmed that we can expand the scope of development to include CT scans using contrast agents in the future. As the market potential for this therapeutic increases, interest is expected to grow and discussions are likely to advance following the release of these results.”