[Special Stock] Aptabio in Talks for Tech Licensing with All Global 'Big 10'... Proven Efficacy of Diabetic Drug Candidate

[Asia Economy Reporter Hyungsoo Park] Aptabio is showing strong performance. The news that Isuzinaxib (APX-115), a treatment for diabetic nephropathy, demonstrated statistical efficacy in its Phase 2 clinical trial appears to be influencing the stock price.

As of 9:17 AM on the 1st, Aptabio is trading at 25,150 KRW, up 14.32% from the previous day.

After hitting the daily price limit on the 29th of last month and closing, the stock has continued its strong trend for two consecutive days.

Diabetic nephropathy, for which Aptabio announced Phase 2 clinical trial results, currently has no globally approved treatments. When the disease occurs, ACE inhibitors or ARBs, which are antihypertensive drugs, are prescribed. RAS (renin-angiotensin system) inhibitors are used for prevention, but they are not fundamental treatments.

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

The Phase 2 results showed that the key 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 over 20% from baseline (P<0.05). In patients with moderate or higher 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). An increase of over 20% in eGFR was also confirmed.

In the APX-115 drug-compliant group (44 patients), UACR decreased by more than 30% compared to the placebo group with statistical significance (P<0.05). Currently, there is no effective treatment for patients with moderate or higher nephropathy, and APX-115 is the only treatment confirmed to be effective.

The success of the Phase 2 trial is expected to lead to a new valuation of the NOX platform pipeline. Expectations for clinical success have also increased for treatments under development based on compounds like Isuzinaxib (APX-115), including COVID-19 treatments, NASH (non-alcoholic steatohepatitis) treatments, macular degeneration treatments, and diabetic retinopathy treatments. Detailed research results of the diabetic nephropathy Phase 2 trial will be presented at the world's largest American Society of Nephrology conference in early November.

An Aptabio representative explained, "The current diabetic nephropathy treatment market is worth 10 trillion KRW, but this is limited to mild cases," adding, "There are no treatments for severe cases yet, so the market potential is very large."

He continued, "APX-115 is in a favorable position to capture the global market," and added, "With the statistical significance secured in Phase 2, negotiations for technology licensing with global big pharma companies are progressing rapidly."

He stated, "We are currently in technology licensing discussions with all of the global top 10 pharmaceutical companies, so good results are expected," and added, "It is also possible to consecutively license out the eight pipelines linked to the NOX platform."

Diabetic nephropathy is a progressive kidney disease caused by structural and functional damage to the glomeruli of the kidneys due to factors such as hyperglycemia and oxidative stress. It is also known as a cause of renal failure. It occurs in 40% to 50% of patients with type 2 diabetes and progresses to chronic renal failure, where life extension is only possible through dialysis treatment or kidney transplantation.

Recently, a research team led by Professor Karin Jandelete-Dahm and Dr. Jay Chandra Jha from Monash University in Melbourne, Australia, authorities in diabetic nephropathy research, identified NOX 5 as a major cause of diabetic kidney damage. Aptabio’s APX-115, a NOX inhibitor, has demonstrated efficacy in this Phase 2 clinical trial for the first time worldwide.