- Rapid reversal of the cytokine cascade in septic patients
- Rapid improvement in inflammatory biomarkers, including leukocytosis, compared to standard treatment
- No serious treatment-related side effects
TOULOUSE, France & LAKELAND, Mich.–(BUSINESS WIRE)–Regulatory News:
ABIONYX Pharma, (FR0012616852 – ABNX – eligible PEA PME)a next-generation biotech company dedicated to the discovery and development of innovative therapies, today presents positive interim results in the Phase 2a clinical trial evaluating CER-001 in the treatment of patients with sepsis at high risk of developing acute kidney injury.
The RACERS study aims to enroll 20 patients with Gram-negative sepsis who are at high risk for acute kidney injury due to elevated levels of endotoxin activity and decline in function of one or more organs. Completion of the study has been delayed since the enrollment of the first study patient in June 2021 due to the COVID pandemic, which has limited the availability of intensive care beds and medical staff for non-COVID patients. To date, thirteen patients have been enrolled and seven remain to be recruited. An interim review of the first ten patients who completed the study was performed.
Compared to standard treatment, CER-001 rapidly improved biomarkers of inflammation, including leukocytosis, as well as endothelial dysfunction, preventing 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 severe treatment-related side effects were observed in this critically ill patient population.
Pr. Loreto Gesualdo, Full Professor, Head of Nephrology, Dialysis and Transplantation Unit, University of Bari Aldo Moro in Italy and principal investigator of the RACERS study, says: “This is the first-in-man study using recombinant Bio-HDL to treat critically ill septic patients. The results obtained to date with CER-001 are consistent with the known pleiotropic effects of HDL, which eliminates endotoxins, reverses the cytokine cascade and improves endothelial function. The response to treatment with CER-001 was rapid, with clinical benefit demonstrated as early as day 3, compared to standard treatment. These preliminary data replicate the results we observed in our porcine preclinical model of sepsis-induced acute kidney injury. We look forward to completing the study and using the results to design the Phase 2/3 study. »
Connie Peyrottes, Senior VP clinical development chez ABIONYX Pharma, ajoute : “We believe that the interim results from the RACERS study represent a unique opportunity for ABIONYX in sepsis, and suggest that CER-001 may have utility as a safe and effective treatment for the most severe inflammation-marked diseases. and organ failure in various high-mortality clinical indications with significant unmet medical needs. »
Cyrille Tupin, Managing Director of ABIONYX, concludes: “The promising interim results of this phase 2a study confirm that CER-001 could potentially fill an existing gap in the treatment of sepsis and other serious and acute inflammatory diseases. If consistent results are confirmed in the latest patients, these results, together with the recently published results in COVID-19, support our strategic decision to develop Bio-HDL as a short-term therapy for the most severe indications. »
Next financial press release: Annual results, April 28, 2022
About ABIONYX Pharma
ABIONYX Pharma is a next-generation biotech company that intends to contribute to health through innovative therapies in indications without effective or existing treatment, even the rarest ones. Thanks to its research partners, doctors, biomedicine producers and shareholders, the company innovates daily to offer drugs for the treatment of kidney and ophthalmological diseases, or new HDL vectors used for the targeted delivery of drugs.
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