AM‐Pharma has reported positive data in a Phase II trial of recombinant Alkaline Phosphatase (recAP) for the treatment of sepsis-associated acute kidney injury (AKI).
Entitled ‘A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI’ (STOP-AKI), the adaptive trial comprises two parts and has enrolled 301 patients.
In the first part, data from 120 patients were analysed to select the most effective dose of recAP, while in the second part, an additional 170 patients were recruited into two arms to provide either the optimal dose of recAP identified initially, or placebo.
The trial was conducted in more than 50 intensive care units (ICU) in Western Europe and North America.
Results of the STOP-AKI study have showed a significant and dose-dependent relative reduction in mortality of more than 40% in the treatment group compared to the placebo group.
The trial’s primary endpoint was met when the addition of recAP to the standard of care did not affect kidney function in the first week of the study, and a significant, progressive and sustained improvement in renal function was demonstrated over the 28-day study period.
During the trial, safety data were regularly reviewed by an independent Data Safety Monitoring Board (DSMB), without reporting any observations of concern.
STOP-AKI principal investigator Peter Pickkers said: “Acute Kidney Injury affects millions of patients each year and comes with a substantial risk of mortality.
“The significant improvements demonstrated in survival and kidney function are very encouraging and strongly support further development of recAP.”
recAP is AM‐Pharma’s proprietary recombinant human alkaline phosphatase (AP) built from two naturally occurring human isoforms of the AP enzyme, which is highly stable and active.