ABIONYX Pharma Reports Positive Results from Phase 2a Pilot Clinical Trial Evaluating CER-001 in the Treatment of Septic Patients at High Risk of Developing Acute Kidney Injury

• Positive results on primary and secondary endpoints, identifying dose for future development
• Direct and significant effect of CER-001 on endotoxin removal and consequent reduction in the inflammatory cascade or “cytokine storm”
• Significant protective effect of CER-001 on endothelial functionality
• Trends towards fewer ICU days for patients treated, lower requirement for organ support and improved 30-day survival were also seen
• Trial reinforces the well-established safety profile of CER-001
• Efficacy results consistent with those observed in COVID-19

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TOULOUSE, France & LAKELAND, Mich.–(BUSINESS WIRE)–ABIONYX Pharma (FR0012616852 – ABNX – PEA PME eligible), a new generation biotech company dedicated to the discovery and development of innovative therapies for patients, today reported that the pilot Phase 2a clinical trial evaluating CER-001, the only natural recombinant apoA-I, as a treatment for septic patients at high risk of developing Acute Kidney Injury (AKI) met its primary objective. There are no approved treatments for septic patients in the world.

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: “We are incredibly excited to share results from this pilot Phase 2a trial evaluating CER-001 in septic patients at high risk of developing acute kidney injury. 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 (Lancet 2022; 400: 2221–48). 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.”

Michael Davidson, M.D., Chairman of the Scientific Advisory Board of ABIONYX concluded: “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 RACERS 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.

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