ABIONYX Pharma announces positive interim results in Phase 2a clinical trials evaluating CER-001 for the treatment of septic patients at high risk of developing acute kidney injury

  • Rapid reversal of cytokine cascade in septic patients
  • Rapid improvement of inflammatory biomarkers, including leukocytosis, compared to standard of care
  • No serious treatment-related side effects

Toulouse, France and Lakeland, Mississippi – (BUSINESS WIRE) – Regulatory News:

ABIONYX Pharma, (FR0012616852 – ABNX – Eligible PEA PME)A next-generation biotechnology company specializing in the discovery and development of innovative therapies, today is a Phase 2a clinical trial evaluating CER-001 in the treatment of septic patients at high risk of developing acute kidney injury. Shows a positive interim result.

The RACERS study aims to enroll 20 patients with Gram-negative sepsis who are at increased risk of acute renal injury due to increased levels of endotoxin activity and decreased function of one or more organs. The COVID pandemic restricted the use of intensive care units and medical staff for non-COVID patients, delaying the completion of the study since the first study patient was enrolled in June 2021. To date, 13 patients have been enrolled and 7 have not yet been recruited. An interim review was conducted on the first 10 patients who completed the study.

Compared to standard of care, CER-001 rapidly improved biomarkers of inflammation such as leukocytosis and endothelial dysfunction and prevented the decline of septic patients to acute kidney injury. Treatment with CER-001 was well tolerated at all doses administered (5, 10, and 20 mg / kg, twice daily). No serious treatment-related side effects were observed in this critically ill patient population.

Dr. Loreto Jezardo, Head of the Department of Nephrology, Dialysis and Transplantation, Bari Aldo Moro University, Italy, and Principal Investigator of RACERS Research, said: “This is the first human study to use recombinant Bio-HDL to treat patients with severe sepsis. The results so far obtained with CER-001 have eliminated endotoxins and reversed the cytokine cascade. Consistent with the known multifaceted effects of HDL on improving endothelial function. The response to treatment with CER-001 is rapid, demonstrating clinical benefit as early as day 3 compared to standard therapy. These preliminary data reproduce the results observed in a pre-porcine clinical model of acute renal impairment due to sepsis. Complete the study and use the results to design a Phase 2/3 study. I’m looking forward to it »».

Connie Peyrottes, Senior Vice President of Clinical Development at ABIONYX Pharma, adds: “We believe that the interim results of the RACERS trial are a unique opportunity for ABIONYX in sepsis, and CER-001 is a safe and effective treatment for organ failure in the most severe inflammatory diseases and various higher diseases. May be useful.-Clinical indication of mortality with significant unmet medical needs. »»

Cyrille Tupin, CEO of ABIONYX, concludes: “Promising interim results from this Phase 2a trial confirm that CER-001 can potentially close existing gaps in the treatment of sepsis and other serious and acute inflammatory diseases. If consistent results are confirmed in patients with, these results, along with the recently published results of COVID-19, support the strategic decision to develop Bio-HDL as a short-term treatment for the most serious indications. increase. “”

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About ABIONYX Pharma

ABIONYX Pharma is a next-generation biotechnology company that aims to contribute to health through innovative therapies for indications, whether effective or existing therapies, or even the rarest. Thanks to research partners, doctors, biomedical producers and shareholders, the company is innovating every day to provide drugs for the treatment of kidney and ophthalmic diseases, or new HDL vectors used for targeted delivery of drugs. increase.

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