- The lead investigator will present an overview of AM-Pharma’s ongoing Phase 3 REVIVAL study at 11:30 AM PT (2:30 PM ET) on Thursday, March 10, 2022; and
- New data underscoring the correlation between acute kidney injury severity and patient outcomes following cardiac surgery will be presented in a poster session today
San Diego, California and Utrecht, The Netherlands, March 7, 2022 – AM-Pharma B.V., an emerging leader focused on developing therapeutics for severe medical conditions, today announced two presentations at the 27th International Conference on Advances in Critical Care Nephrology in San Diego, CA. In the oral presentation at 11:30 a.m. on Thursday, March 10, 2022, Dr. Peter Pickkers, Professor of Experimental Intensive Care Medicine at Radboud University Nijmegen Medical Center, will provide an overview of AM-Pharma’s ongoing Phase 3 REVIVAL study. The second presentation is a poster with new data supporting the importance of managing acute kidney injury (AKI) in patients undergoing cardiac surgery, which will be presented today.
Poster Presentation: Effect of AKI Stage on Clinical Outcomes and Residual Renal Function in Adult Patients Undergoing On-Pump Cardiac Surgery
The poster presentation contains data from a retrospective study that assessed more than 6,800 patients having undergone cardiac surgery and found that patients with AKI were significantly more likely to experience a Major Adverse Kidney Event within 90 days (MAKE90). Major Adverse Kidney Events is a potential endpoint for phase 3 studies in acute kidney disease as it includes three important patient outcome components: death, new onset dialysis and sustained reduction in kidney function. The full data from this study was presented in a poster today at the 27th International Conference on Advances in Critical Care Nephrology in San Diego, California.
This study was a retrospective analysis of electronic medical records from the Cerner® Real-World Data database of adult U.S. patients from January 1, 2016, to December 31, 2020. The authors reviewed records from approximately 22,000 cardiac surgery patients and 6,821 met the inclusion criteria for this study. For each patient included in the study, the authors reviewed the incidence and stage of AKI 5 days post-surgery, the patients’ eGFR and the incidence of MAKE90 events. Of the 6,821 patients in this study, 3,416 experienced no AKI and 3,405 experienced AKI post-surgery. The presence of acute kidney injury post-surgery was associated with significantly more MAKE90 events, with 28.7% of patients with AKI having experienced a MAKE90 event compared to only 7.8% of patients with no AKI. Additionally, 747 patients were categorized with more severe AKI (AKI stage 2/3) and those patients suffered even worse outcomes, with nearly 70% experiencing a MAKE90 event. In addition, the data demonstrate that the kidney function as assessed by eGFR within the 90 days interval was profoundly reduced when the patients developed severe AKI.
“These data are important to AM-Pharma as we seek to initiate a phase 3 study for ilofotase alfa this year to mitigate the risk of AKI in cardiac surgery patients,” said Maarten Kraan, M.D, Ph.D., Chief Medical Officer of AM-Pharma. “Up to 30% of patients undergoing cardiac surgery suffer from concomitant AKI. We believe that better management of Cardiac Surgery Associated-AKI may significantly improve outcomes for these patients.”
Andrew Shaw, M.D., Chairman, Department of Intensive Care and Resuscitation at The Cleveland Clinic and primary author on this study, commented, “The data from this study highlight the importance of acute kidney injury in the setting of cardiac surgery, and demonstrate the extent of the unmet medical need in this disease space. The MAKE composite endpoint is important because it includes three components of critical importance for patients: death, new onset dialysis and sustained reduction in kidney function. The incidence of MAKE90 in patients who developed AKI after the surgery was 28.7% – so one in 3-4 patients – and even higher in moderate to severe AKI with 7 out of 10 patients positive for MAKE.”
About Ilofotase Alfa
Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase, that was shown in multiple clinical trials to be stable and highly active. Systemic administration of ilofotase alfa demonstrated potent inhibition of acute inflammation in kidney, lungs, liver, gut and other organs resulting in survival improvement of critically ill patients. The recombinant enzyme displays exquisite activity towards dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs) such as lipopolysaccharide (LPS), ATP, ADP and other extracellular substrates that drive acute inflammation, coagulation and microvascular ischemia found in kidney, lung and liver following sepsis or ischemia-induced damage. Research has shown that ATP dephosphorylation has a double effect in protecting against kidney injury. When the pro-inflammatory ATP is dephosphorylated, the resulting adenosine further reduces inflammation through the activation of the immunosuppressive adenosine A2a receptor pathway.
AM-Pharma’s purpose is to save and improve the lives of patients confronted with severe medical conditions. Our initial focus is sepsis-associated acute kidney injury, the cause of death for hundreds of thousands of people hospitalized each year. Our proprietary compound, ilofotase alfa, has the potential to become the first treatment for sepsis-associated acute kidney injury and is now in a global pivotal Phase III clinical trial. We are a dedicated team driven to bring treatment options to severely ill patients, their families and acute care professionals. Find out more about us online at: www.am-pharma.com.
Gretchen Schweitzer or Eva Mulder