French biotechnology company ABIONYX Pharma has published preclinical data for its CER-001 drug candidate, which is indicated to treat brain dysfunction associated with acute kidney injury.

Also known as brain fog, the condition is a set of symptoms that indicate a decrease in the quality of mental functioning.

CER-001 is a negatively charged lipoprotein particle composed of human recombinant apoA-I, the natural HDL protein, along with sphingomyelin (Sph) and dipalmitoylphosphatidylglycerol (DPPG) natural phospholipids.

ABIONYX Pharma is sponsoring the preclinical study, which aims to evaluate the effects of recombinant apoA‑I phospholipid complexes in minimising the inflammatory process and preventing sepsis-induced acute renal failure and brain dysfunction.

Blood samples showed a notable decrease in the activity of the Indolamine-2,3-dioxygenase enzyme in both CER-001 dose groups (20 mg/kg and 2×20 mg/kg).

This reduction was observed through the measurement of the kynurenine/tryptophan ratio (p<0.05) and quinolinic acid levels (p<0.005), compared to the untreated control group.

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In addition, CER-001 treatment led to a reduction in both systemic and brain interleukin-6 (IL-6) levels.

Taken together, the data suggest that treatment with CER-001 can lessen the inflammatory response, and retention of residual substances and neuroactive compounds, as well as potentially enhance both renal and cognitive function in cases of sepsis-induced acute renal failure.

University of Bari Aldo Moro nephrology, dialysis and transplantation unit head and RACERS study principal investigator professor Loreto Gesualdo said: “Following our exclusive presentation of robust data in sepsis at the ASN in early November, the results obtained in Brain Fog demonstrate the broad spectrum of efficacy of CER-001, one of the world’s most advanced biologics.

“The unique properties conferred by recombinant apoA-I lipoprotein complexes appear to potentially reduce kidney and brain disorders in patients suffering from sepsis.

“Taken together, these data support the clinical development of CER-001 in potential new indications affecting the gut-kidney-brain axis.”