We are delighted to report that our clinical trial has produced positive results on both primary and secondary endpoints, allowing us to identify a dose for future development. This marks a major milestone in our progress towards creating a successful new treatment.
CER-001 has been proven to have a dramatic effect on endotoxin removal and reducing the inflammatory cascade, commonly referred to as the “cytokine storm.” This has been demonstrated to be a crucial breakthrough in the fight against serious illnesses caused by excessive inflammation.
CER-001 has been found to have an impressive protective effect on endothelial functionality, making it a promising potential treatment for a variety of conditions. With further research and clinical trials, CER-001 could revolutionize the way we approach and treat cardiovascular disease.
Patients treated in ICUs have seen a decrease in the number of days spent there, a reduced need for organ support, and an increased chance of surviving for 30 days. This has been a positive trend towards better outcomes for those in ICUs.
The safety profile of CER-001 has been reaffirmed through a recent clinical trial, confirming its well-established track record of safety and efficacy.
The efficacy results of COVID-19 are remarkable and consistent with what has been observed in other studies. This demonstrates the potential of this virus to be contained and controlled, giving us hope that the pandemic can be managed effectively.
ABIONYX Pharma, a biotech company dedicated to developing innovative therapies for patients, has announced exciting news: the Phase 2a clinical trial evaluating CER-001, a natural recombinant apoA-I, as a treatment for septic patients at high risk of developing Acute Kidney Injury (AKI), has successfully met its primary objectives. This breakthrough therapy could provide a much-needed solution to the lack of approved treatments for septic patients around the world.
We are thrilled to present the results of the RACERS study, a Phase 2a trial that investigated the efficacy of CER-001 in septic patients at risk of acute kidney injury. This is a major breakthrough, as there are currently no treatments for this life-threatening condition, which claimed an estimated 13.7 million lives globally in 2019 (Lancet 2022; 400: 2221–48). Excitingly, the trial revealed promising outcomes across a variety of primary and secondary endpoints. CER-001 was found to reduce harmful endotoxins, control the cytokine storm, and protect the endothelium. What’s more, the drug showed positive trends in reducing renal damage, decreasing the need for organ support and shortening ICU-stay. These results suggest that CER-001 could have a significant clinical impact.
The groundbreaking findings of the Phase 2a study have revealed that CER-001 may be a viable treatment for sepsis and other severe, acute inflammatory diseases. Dr. Michael Davidson, Chairman of the Scientific Advisory Board of ABIONYX, has stated that these results are in line with the previously reported successes in COVID-19 and pave the way for the use of CER-001 in the short-term management of acute conditions.
The results of the RACERS trial for CER-001 in COVID-19 were recently published in Frontiers in Medicine, a specialty medicine journal, in September 2022, and they were found to be in line with prior clinical data. This is a testament to the safety and efficacy of this promising treatment.
CER-001 is being clinically developed as a potential treatment for septic patients, a group of individuals suffering from a debilitating and often deadly condition for which there are currently no available treatments. Soon, discussions between regulatory authorities in Europe and the United States will take place to design an effective clinical and regulatory development plan for CER-001, in the hopes of providing a much-needed solution to this devastating ailment.