Bilix announced on Tuesday that it has received approval from the Ministry of Food and Drug Safety (MFDS) for its Investigational New Drug (IND) application to conduct a domestic Phase 2a clinical trial for BX-001N (brand name Brixelle), a potential treatment for Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI).
The clinical trial is titled “A Randomized, Single-Blind, Placebo-Controlled, Multicenter Phase 2a Clinical Trial for the Prevention of Cardiac Surgery-Related Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE) Following Intravenous Administration of Brixelle.”
This trial follows the successful Phase 1 study in Australia, which demonstrated Brixelle’s strong safety profile and tolerability. The new study aims to evaluate its efficacy and safety in patients within the country.
CSA-AKI, the target condition for this Phase 2a trial, affects 20% to 30% of patients undergoing cardiac surgery. It can result in kidney function deterioration and, in severe cases, lead to dialysis or death. Despite its severity, there are currently no approved drugs for prevention or treatment, highlighting a significant unmet medical need.
Kim Myung Lip, Chief Executive Officer (CEO) of Bilix, stated that the successful Phase 1 trial in Australia has established the safety of Brixelle. Furthermore, if it can confirm its efficacy and safety for acute kidney injury in cardiac surgery patients during this Phase 2a trial, it may further support its use. In that case, it may be able to expand its application to address ischemia-reperfusion injury in organ transplantation and acute myocardial infarction as well.