LAKELAND–Abionyx Pharma reported that the pilot Phase 2a clinical trial evaluating its drug candidate CER-001, the only natural recombinant apoA-I, as a treatment for septic patients at high risk of developing Acute Kidney Injury met its primary objective. There are no approved treatments for septic patients in the world.
“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,” said Loreto Gesualdo, provessor and heat of the neprhology, dialysis and transplantation unit at the University of Bari Aldo Moro, Italy, lead investigator of the study. “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.”
Added Michael Davidson, M.D., chair of the scientific advisory board of Abionyx: “The impressive results of this Phase 2a study confirm that CER-001 may potentially treat sepsis and other severe, acute inflammatory diseases. These results are consistent with the previously published results in COVID-19 and opens a new chapter in the development of CER-001 in the field of short-term therapy for acute conditions.”
The observed safety and efficacy in the study were generally consistent with historical data including clinical results for CER-001 in COVID-19 that were published recently in the scientific journal “Frontiers in Medicine”, a specialty medicine journal, in September 2022.
The potential use of CER-001 in septic patients is currently under clinical development. These data will be discussed with regulatory authorities, starting with Europe but also the U.S. later this year in order to design an appropriate clinical and regulatory development strategy for this disease state that currently has no available treatment options.
Abionyx has operations in Lakeland, Mich. and Toulouse, France.