AM-Pharma Begins Phase 2 Trial of Ilofotase Alfa For Renal Damage Prevention

AM-Pharma B.V. announced that the first individuals have been given treatment in Phase 2 clinical research that is testing the company’s patented alkaline phosphatase, ilofotase alfa, as a preventative therapy for cardiac surgery-related renal damage (CSA-RD). 

Ilofotase alfa is a patented synthetic alkaline phosphatase. It is built from two human alkaline phosphatase isoforms and has been demonstrated in a number of clinical trials to be both stable and extremely active.

In spite of the fact that more than two million open heart surgeries are carried out every year around the globe, CSA-RD remains a significant surgical complexity for which there is no particular pharmaceutical treatment. 

Acute kidney damage (AKI) that occurs immediately after cardiac surgery is the cause of chronic renal dysfunction (CSA-RD), which is characterized as the long-term damage to renal function in individuals who have had heart surgery. It is estimated that roughly one out of every three patients who undergo open-heart surgery will experience CSA-AKI. This condition is the most common cause of death after surgery, and as such, 2 to 5% of patients will require renal replacement therapy. There is an excellent history of renal protective benefits that have been demonstrated in past research, and ilofotase alfa has a known safety and tolerability record. 

In sepsis-associated acute kidney injury (AKI), it is noteworthy that previous Phase 2 and Phase 3 studies with ilofotase alfa illustrated substantial progress in Major Adverse Kidney Events by day 90 (MAKE90). In the REVIVAL Phase 3 study, MAKE90 events decreased to 57.2% of the participants in the ilofotase alfa group, whereas in the placebo group, the number of patients who had these events was 64.7%. This information was recently disclosed in a publication.

Peter Pickkers, Ph.D, the chief investigator in the phase 2 study, remarked, “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.”

The Phase 2 study will examine the effectiveness and safety of ilofotase alfa as a preventative medication in a total of 150 patients who are scheduled to have cardiac surgery and are at risk for coronary artery disease (CSA-RD). The trial will be randomized and placebo-controlled. 

The administration of treatment will take place both before and after the surgical procedure, and there will be a follow-up time of 60 days. As the main endpoint, the proportion of creatinine levels before and after surgery will be the major focus of monitoring. 

Significant exploratory objectives will include the occurrence of Major Adverse Kidney Events (MAKE), as well as the occurrence and severity of AKI following surgical procedures. The study is scheduled to conclude in the fourth quarter of 2024, and a data readout is anticipated to take place in the beginning of 2025. 

Recent research conducted in a Phase 1b pilot investigation assessed the efficacy of ilofotase alfa as an enzyme replacement therapy for patients suffering from hypophosphatasia.

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