Aptabio (CEO Sujin Lee), a developer of treatments for refractory anticancer drugs and diabetic complications, announced on the 3rd that it has received approval from the Ministry of Food and Drug Safety for the domestic Phase 2 clinical trial plan (IND) of the contrast agent-induced acute kidney injury treatment ‘Aisujinaxib (APX-115)’.
Previously, in February, Aptabio applied to the Ministry of Food and Drug Safety for the domestic Phase 2 clinical trial plan (IND) of the contrast agent-induced acute kidney injury treatment ‘Aisujinaxib (APX-115)’. Through this clinical trial, Aptabio plans to evaluate the safety and efficacy of ‘APX-115’ against contrast agent-induced acute kidney injury in patients undergoing percutaneous coronary intervention.
Contrast agents are drugs administered to the human body to enhance the visibility of tissues or blood vessels during radiological examinations such as CT and MRI. Contrast agent-induced acute kidney injury (CI-AKI) refers to the acute deterioration of kidney function following the administration of contrast agents. Contrast agent-induced acute kidney injury is known to be associated not only with short-term complications due to decreased kidney function but also with long-term chronic renal failure and mortality. In particular, the incidence of related complications and mortality due to contrast agent-induced acute kidney injury is increasing in patients undergoing cardiovascular interventional procedures.
Despite these risks, there are currently no treatments available for contrast agent-induced acute kidney injury.
Aptabio is developing a treatment for contrast agent-induced acute kidney injury using the innovative drug candidate ‘APX-115’, derived from an oxidative stress regulation platform.
‘APX-115’ has demonstrated effects in animal models of contrast agent-induced acute kidney injury, including improvement in blood BUN (Blood urea nitrogen) and creatinine levels, reduction of kidney injury markers, improvement of tubular injury, reduction of inflammation in kidney tissue, decreased infiltration of inflammatory cells in kidney tissue, and reduction of oxidative stress.
An Aptabio representative stated, “Following the approval of the Phase 2 clinical trial plan for ‘APX-115’ by the US FDA in January, we have now also received approval for the domestic Phase 2 trial plan. We plan to successfully conduct this clinical trial and take the lead in developing treatments for contrast agent-induced acute kidney injury.”
Meanwhile, Aptabio had previously received approval from the US FDA for the Phase 2 clinical trial plan of ‘Aisujinaxib’ in January.
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
