ABIONYX Pharma Reports Positive Interim Results From Phase 2a Clinical Trial Evaluating CER-001 in the Treatment of Septic Patients at High Risk of Developing Acute Kidney Injury
07 Avril 2022 - 07:30AM
Business Wire
- Rapid reversal of cytokine storm in septic patients
- Enhanced resolution of biomarkers for inflammation including
leukocytosis compared to standard of care
- No treatment-related serious side effects
Regulatory News:
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 positive interim results of an open-label Phase 2a
clinical trial evaluating CER-001 as a treatment for septic
patients at high risk of developing Acute Kidney Injury (AKI).
The RACERS study aims to include 20 patients with gram-negative
sepsis who are at high risk for acute kidney injury due to high
levels of endotoxin activity and decline in function of one or more
organ systems. Completion of the study has been delayed due to the
COVID pandemic, which has limited availability of critical care
beds and medical staff for non-COVID patients, since the first
study patient was enrolled in June 2021. To date, thirteen patients
have been enrolled and seven remain to be recruited. An interim
review for the first ten patients to complete the study has been
performed.
Compared to standard of care therapy, CER-001 rapidly improved
biomarkers of inflammation including leukocytosis, and endothelial
dysfunction, preventing septic patients’ decline into acute kidney
injury. CER-001 treatment was well tolerated at all dose levels (5,
10 and 20 mg/kg, twice a day). No treatment-related serious side
effects were seen in this critically ill patient population.
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: “This is
the first study in humans using a recombinant Bio-HDL to treat
acutely ill septic patients. The results to date with CER-001 are
consistent with the known pleiotropic effects of HDL, scavenging
endotoxin, reversing the cytokine cascade and improving endothelial
function. Response to CER-001 treatment was rapid, relative to
standard of care therapy, with clinical benefit demonstrated as
soon as Day 3. These preliminary data reproduce the results we
observed in our pre-clinical swine model of sepsis-induced AKI. We
look forward to completing the study and using the results to
design the phase 2/3 study.”
Connie Peyrottes, Senior VP clinical development at ABIONYX
Pharma, added: “We believe the interim results from the RACERS
study represent a unique opportunity for ABIONYX in the sepsis
landscape, and suggest that CER-001 may have utility as a safe and
effective treatment for critical illnesses marked by inflammation
and organ failure across different high mortality clinical
indications with high unmet medical needs.”
Cyrille Tupin CEO of ABIONYX concluded: “The promising interim
results of this Phase 2a study confirm that CER-001 could
potentially fill a void that exists in treating sepsis and other
severe, acute inflammatory diseases. If consistent results are
found in the remaining patients, these results, along with the
recently published results in COVID-19, support our strategic
decision to develop bio-HDL as short-term therapy for acute
conditions.”
Next financial press release :
Annual Results, April 28th 2022
About ABIONYX Pharma
ABIONYX Pharma is a new generation biotech company that aims to
contribute to health through innovative therapies in indications
where there is no effective or existing treatment, even the rarest
ones. Thanks to its partners in research, medicine,
biopharmaceuticals and shareholding, the company innovates on a
daily basis to propose drugs for the treatment of renal and
ophthalmological diseases, or new HDL vectors used for targeted
drug delivery.
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NewCap Investor relations Louis-Victor Delouvrier
abionyx@newcap.eu +33 (0)1 44 71 98 53
NewCap Media relations Arthur Rouillé abionyx@newcap.eu
+33 (0)1 44 71 00 15
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