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[미국 22.11.04 배포] Aptabio to present results of Isuzinaxib Phase 2 study at The American Society of Nephrology (ASN)'s Kidney Week 2022

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Aptabio's Isuzinaxib (APX-115) proves its effect on a key kidney function marker in a Phase 2 clinical study in patients with diabetes and chronic kidney disease.

  • Isuzinaxib (APX-115) is a novel pan-NOX inhibitor modulating oxidative stress.
  • Isuzinaxib (APX-115) significantly reduced the Urine Albumin Creatine Ratio (a marker of kidney damage) versus placebo in patients with especially low kidney function.
  • Isuzinaxib (APX-115) demonstrates the potential kidney benefits in patients with diabetes and chronic kidney disease.

ORLANDO, Fla. and YONGIN, South KoreaNov. 4, 2022 /PRNewswire/ -- Aptabio will present Isuzinaxib Phase 2 clinical trial[1] results at the American Society of Nephrology (ASN)'s Kidney Week 2022 in Orlando, FL.

The study results will be presented in High-Impact Clinical Trials, oral abstract session.

Friday, November 410:30 a.m. – 12:30 p.m. EDT Oral Abstract Session
High-Impact Clinical Trials
FR-OR62 Effect of Isuzinaxib, Pan NOX Inhibitor in Patients With Type 2 Diabetes and CKD in a Randomized, Double Blind, Placebo Controlled Phase 2 Trial

Chronic Kidney Disease (CKD) is highly prevalent, irreversible, progressive, and associated with higher cardiovascular risk. Diabetes is the leading cause of kidney disease, and about 1 out of 3 adults with diabetes have kidney disease[2].

Isuzinaxib (APX-115) is a novel investigational pan-NOX inhibitor modulating to oxidative stress that leads a critical pathogenic factor in the initiation and progression of diabetic complications.

The results of a randomized, double-blind, placebo-controlled phase 2 study in 140 patients with diabetes and chronic kidney disease showed that Isuzinaxib was effective on major kidney function markers (Urine Albumin Creatine Ratio and Kidney Injury Molecule-1), especially the patients with a low kidney function (CKD Grade 3b) achieved an UACR difference -47% in the Isuzinaxib group in 12-week treatment orally compared to the placebo group.

"This study demonstrates the first clinical evidence of Isuzinaxib's effectiveness in diabetic kidney disease. The future clinical developments will be likely focus on the advanced chronic kidney disease patients." said Dae Ryong Cha, MD, PhD of the Korea University College of Medicine.

About Isuzinaxib (APX-115)

First-in-class pan-NOX inhibitor, Oxidative stress modulator

APX-115 is a potent small-molecule inhibitor of NADPH-oxidase (NOX) isozymes developed by Aptabio Therapeutics for the treatment of diabetic kidney disease.

The NADPH-oxidase (NOX) enzymes represent a family of seven membrane enzymes, which catalyze NADPH-dependent generation of superoxide and secondary Reactive Oxygen Species (ROS) which can cause tissue damage and modification of cell function.

NOXs-mediated ROS production triggers for increased oxidative metabolism leading to inflammatory responses and profibrotic factors. Targeting NOX enzymes may lead to more effective inhibition of oxidative stress at early stage of ROS production. ROS triggers kidney cells to secret cytokines which potentiate activation of macrophages, that also contribute to Diabetic Kidney Disease.

Pan-NOX inhibitor, attenuates most of NOX isoform, suggesting a new therapeutic strategy against Diabetic Kidney Disease.

About Aptabio Therapeutics Inc.

Platform Technology-Based First-in-Class New Drug Development Company

Aptabio is a Korean biopharmaceutical company established in 2009. Since then, Aptabio has thrived by being a pioneer and an innovator in the biopharmaceutical industry, developing platform-based first-in-class drugs for intractable diseases. The word 'Apta' means 'too fit' in Greek. To fit the unmet needs of the patients with the intractable disease, Aptabio pursues scientific excellence in developing new drugs hoping to provide a better cure and life for such patients and their families.

[1] NCT04534439: A randomized, Placebo-controlled, Double-blinded, Multi-centre, Phase II Study to Assess Safety, Tolerability and Renal Effects of APX-115 in Subjects with Type 2 Diabetes and Nephropathy

[2] Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2019. Atlanta, GA: US Department of Health and Human Services. Centers for Disease Control and Prevention; 2019.

SOURCE Aptabio Therapeutics Inc.