ABIONYX Pharma SA announced that the last patient has been enrolled in the Phase 2a clinical trial evaluating CER-001, Bio-HDL, as a potential treatment for patients with sepsis at high risk of developing acute kidney injury. RACERS is a randomized, open-label, placebo-controlled, parallel-group, Phase 2a study evaluating the safety and efficacy of CER-001 administered intravenously to critically ill patients with sepsis who are at high risk of acute kidney injury (AKI) based on their Sequential Organ Failure Assessment (SOFA) score. A total of 20 patients were randomized to receive CER-001 or placebo over 6 days.

The primary endpoint of the study was the onset and severity of acute renal failure according to KDIGO criteria, as well as the safety and tolerability of the dosing regimens, to select the optimal dose of CER-001. Additional efficacy parameters included changes from baseline levels of endotoxin and key inflammatory biomarkers. The clinical study is being conducted in partnership with the University of Bari.

The company reconfirms that the final topline results will be reported by the end of fall 2022.