AM-Pharma Begins Phase 2 Trial of Ilofotase Alfa for Cardiac Surgery

India Pharma Outlook Team | Tuesday, 16 January 2024

 India Pharma Outlook Team

AM-Pharma B.V. stated that the first patients have been treated in a Phase 2 clinical trial assessing the company's proprietary recombinant alkaline phosphatase, ilofotase alfa, as a preventive treatment for cardiac surgery-associated renal damage (CSA-RD). With over 2 million open heart surgeries conducted each year worldwide, CSA-RD is a serious surgical complication for which there is no specific pharmaceutical treatment. CSA-RD is described as the long-term loss of renal function in cardiac surgery patients that results from acute kidney damage (AKI) right after surgery. 

CSA-AKI occurs in approximately 1 out of 3 patients undergoing open heart surgery and is the predominant risk factor for death post-surgery, with 2-5% of patients requiring renal replacement therapy as a result. Ilofotase alfa has a proven safety and tolerability profile and a strong record of renal protective effects as observed in previous clinical studies, as per busineswire.

Notably, previous Phase 2 and Phase 3 trials using ilofotase alfa showed significant reductions in Major Adverse Kidney Events by Day 90 (MAKE90) in sepsis-associated AKI. According to a recent publication2 on the REVIVAL Phase 3 study, MAKE90 events occurred in only 57.2% of patients in the ilofotase alfa group, compared to 64.7% in the placebo group.

“Previous clinical trials showed ilofotase alfa had significant reno-protective effects in sepsis-associated AKI patients. Given the role of AKI in long-term renal impairment in cardiac surgery patients, ilofotase alfa preventative treatment could have substantial clinical benefits on renal function and potentially save lives,” said Peter Pickkers, MD, PhD, Principal Investigator in the Phase 2 study and Professor of Experimental Intensive Care Medicine at Radboud University Nijmegen Medical Centre, The Netherlands.

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