Aptabio "APX-115 Demonstrates Statistical Efficacy in Phase 2 Clinical Trial for Diabetic Nephropathy"

[Asia Economy Reporter Lee Gwan-joo] Aptabio announced on the 29th that it has demonstrated statistical efficacy in the Phase 2 clinical trial of 'Isuzinaxib (APX-115)' for the treatment of diabetic nephropathy.

The Phase 2 clinical trial of Isuzinaxib for diabetic nephropathy was conducted at 16 hospitals across 4 European countries, involving a total of 140 patients with type 2 diabetic nephropathy?68 in the drug administration group and 72 in the placebo group. Isuzinaxib 400 mg or placebo was administered orally once daily, and efficacy and safety were evaluated over 12 weeks.

Results from the Phase 2 trial showed that the primary biomarker for kidney disease evaluation, UACR (urine albumin-to-creatinine ratio), decreased by less than 3% in the placebo group, whereas the Isuzinaxib group showed a reduction of more than 20% compared to baseline (P<0.05). Additionally, in patients with moderate or worse nephropathy with low glomerular filtration rate (eGFR <45), UACR was statistically significantly reduced by more than 50% compared to the placebo group (P<0.05), and eGFR increased by more than 20%.

Notably, in the APX-115 drug compliance group (44 patients), UACR decreased by more than 30% compared to the placebo group with statistical significance (P<0.05). According to the company, there is currently no effective treatment for patients with moderate or worse nephropathy, and APX-115 is the only treatment confirmed to be effective. Regarding safety, there was no difference in the incidence of adverse reactions compared to the placebo group, and the incidence rate was below 5%, with all cases recovering during the dosing period and no abnormal symptoms or signs reported.

The detailed research results of this Phase 2 clinical trial are scheduled to be presented at the American Society of Nephrology in early November. An Aptabio official stated, “The current diabetic nephropathy treatment market is worth 10 trillion KRW, which is limited to mild cases, and there is no treatment for severe cases yet, so the market potential is very high,” adding, “We are currently in technology export negotiations with all of the global top 10 pharmaceutical companies, so good results are expected.”

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