Bilix wins nod for phase 2a trial of Brixelle in cardiac surgery-linked acute kidney injury

Bilix announced on Thursday that it has received approval from the Ministry of Food and Drug Safety (MFDS) for its phase 2a IND for BX-001N (Brixelle in trademark name), a candidate for the treatment of cardiac surgery-associated acute kidney injury (CSA-AKI).

The study is a randomized, single-blind, placebo-controlled, multicenter, phase 2a clinical trial for the prevention of CSA-AKI and subsequent major adverse cardiac events (MACE) after intravenous infusion of Brixelle. Bilix has secured five hospital clinical sites in Korea for the trial, which is expected to begin dosing in September and aims to achieve phase 2a results in the first half of next year.

Following the excellent safety and tolerability of Brixelle in the phase 1 study in Australia, this is a significant step forward in evaluating its efficacy and safety in Korean patients," Bilix said.

Bilix, a Korean biotech company co-founded by CEO Kim Myung-lip and Professor Jon Sang-yong of KAIST's Department of Life Sciences, has developed the world's first pegylated bilirubin platform technology, which enables the drugization of bilirubin with potent anti-inflammatory and antioxidant effects. Brixelle has a long half-life of 124 hours when administered intravenously, making it easy to administer and providing long-lasting therapeutic effects.

CSA-AKI, the indication for this study, occurs in 20-30 percent of cardiac surgery patients. It is a serious condition that can lead to kidney deterioration and, in severe cases, dialysis or death. However, there are no approved drugs to prevent or treat it, making it an area of significant unmet medical need.

In addition, Brixelle has the potential to be a “first-in-class” treatment for various inflammatory diseases, including CSA-AKI. Through future indication expansion, it may also be used to treat ischemia-reperfusion injury in organ transplantation and acute myocardial infarction.

"The successful phase 1 clinical trial in Australia demonstrated the safety of Brixelle. If the phase 2a clinical trial confirms its efficacy and safety in acute kidney injury in real cardiac surgery patients, we will be able to expand the indications to include not only CSA-AKI but also ischemia-reperfusion injury in organ transplantation and acute myocardial infarction," CEO Kim said.