AM-Pharma B.V. announced positive results from its adaptive Phase II study in 301 sepsis patients with Acute Kidney Injury (AKI), the largest therapeutic study in AKI to date.
“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,” Professor Peter Pickkers, MD PhD, Chair of Experimental Intensive Care Medicine, Radboud University Medical Center, and principal investigator of the STOP-AKI study said.
The STOP-AKI study demonstrated a significant and dose-dependent relative reduction in mortality of more than 40% in the treatment group compared to the placebo group. While the addition of recAP to the standard of care did not affect kidney function in the first week of the study (the primary endpoint), it did show a significant, progressive and sustained improvement in renal function over the 28-day study period. Throughout the study, safety data were regularly reviewed by an independent Data Safety Monitoring Board (DSMB), without any observations of concern.
Previously, the US Food and Drug Administration granted Fast Track designation to recAP for the treatment of sepsis-associated acute kidney injury. Acute Kidney Injury involves inflammatory processes in the kidney which can lead to complete loss of renal function and is associated with high mortality rates.