A pilot Phase IIa clinical trial evaluating Abionyx Pharma’s CER-001 as a treatment for septic patients at high risk of developing acute kidney injury (AKI) has met its primary endpoint.
The RACERS study included 20 patients with gram-negative sepsis who were at high risk for acute kidney injury due to high levels of endotoxin activity and decline in function of one or more organ systems.
Patients received either standard of care treatment alone, or in combination with one of three dosage regimens of CER-001 (five patients per group).
Loreto Gesualdo, full Professor, Head of the Nephrology, Dialysis and Transplantation Unit, University of Bari Aldo Moro, Italy, and lead investigator of the RACERS study, stated: “There is a complete lack of treatment options for septic patients at high risk of developing acute kidney injury, a disease that in 2019 had an estimated 13.7 million related deaths globally.
“The trial shows promising positive results across a variety of primary and secondary endpoints. CER- 001 was significantly able to scavenge endotoxins, modulate the cytokine storm, and provide endothelial protection. The trend observed in reducing renal damage, the need for organ support and ICU-day stay underscores the potential clinical significance of these results.”
Sustained reduction in endotoxin levels
One of the metabolic characteristics of bacterial or virus infections is the strong decrease of circulating lipoprotein and particularly the High-Density Lipoprotein (HDL) with its main containing protein apolipoprotein A-I (apoA-I).
In the RACERS study, CER-001 demonstrated a rapid and sustained reduction in endotoxin levels and consequent reduction in the inflammatory cascade or “cytokine storm”. Endothelial biomarkers demonstrated a significant protective effect of CER-001.
Connie Peyrottes, Senior VP clinical development at Abionyx Pharma, added: “The positive results from this Phase IIa trial show CER-001 has the potential to be a gamechanger for critical illnesses marked by inflammation and organ failure across different high mortality clinical indications which continue to have high unmet medical needs.”