Aptabio Presents Phase 2 Results of Diabetic Nephropathy Treatment at US Conference... Primary Endpoint Not Met

No Statistical Significance Achieved Compared to Placebo Group
Company States "Primary Clinical Objective Was Met"

On the 4th (local time), Professor Cha Dae-ryong of the Department of Nephrology at Korea University College of Medicine presented the Phase 2 clinical trial results of Aptabio's Aisuji Naxib at the American Society of Nephrology.

[Asia Economy Reporter Kim Young-won] The Phase 2 clinical trial results of Aptabio's diabetic nephropathy treatment 'Isuzinaxib (APX-115)' were selected as the most pivotal clinical study (HICT) oral presentation of the year at the American Society of Nephrology's Kidney Week 2022. However, APX-115 did not achieve statistical significance in the primary efficacy endpoint across the entire patient population in the Phase 2 results, leading to criticism that it cannot be considered a 'clinical success.'

On the 8th, Aptabio announced that APX-115 was selected as one of the nine HICT studies. The HICT oral presentation was delivered on the 4th (local time) by Professor Cha Dae-ryong of the Department of Nephrology at Korea University College of Medicine.

A company official explained, "The HICT oral presentations are selected by the American academic committee composed of world-renowned nephrology experts," adding, "Presenting the Phase 2 clinical results of APX-115 at this event means that the clinical outcomes have been recognized by experts."

However, according to the Phase 2 key results disclosure released by Aptabio following the lifting of the conference embargo, statistical significance in UACR reduction was confirmed in the severe kidney disease patient group and the drug-compliant group compared to placebo, but not in the overall patient group.

In the Phase 2 results of APX-115, the overall patient group (140 patients) showed a 2.5% decrease in UACR (urine albumin-to-creatinine ratio) in the placebo group (72 patients) and a 20.6% decrease in the APX-115 treatment group (68 patients), but the P-value was 0.088, indicating no statistical significance.

In the severe kidney disease patient group with low glomerular filtration rate (eGFR < 45) and the drug-compliant group who properly took APX-115, the reduction in UACR compared to placebo was statistically significant. In the severe group, UACR decreased by more than 50% compared to placebo, and in the compliant group, it decreased by more than 30%, both statistically significant.

The company stated that since therapeutic effects were confirmed in two out of the three primary efficacy endpoint groups, the clinical trial objectives were achieved. A company representative said, "All three groups?overall, severe, and compliant?are primary endpoint categories, and in the overall group, many patients did not take the drug well, so statistical significance was not achieved, which means there was no harm," adding, "The purpose of Phase 2 was to confirm whether there is a therapeutic effect in patients, and since significance was confirmed in the severe and compliant groups, we believe the objectives of Phase 2 were sufficiently met."

In fact, the primary endpoint registered on the European clinical trial registry for this study was 'Change in UACR of APX-115 compared to placebo after 12 weeks of dosing,' and subgroup analyses such as compliant and severe groups were not listed.

This content was produced with the assistance of AI translation services.