AM-Pharma B.V. recently announced positive results of a phase 2 study on use of its recombinant human alkaline phosphatase, known as recAP, to treat sepsis-associated acute kidney injury.
The trial, which included 301 patients with sepsis and acute kidney injury, showed a 40% relative reduction in mortality compared to patients who received placebo.
Peter Pickkers, MD, PhD, chair of experimental intensive care medicine at Radboud University Medical Center and principal investigator of the STOP-AKI study said in a company press release, “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.”
The adaptive phase 2 trial consists of two parts. Data from 120 patients were evaluated to select the most effective dose of recAP. Second, an additional minimum of 170 patients were recruited into two arms. One arm of the study received either the optimal dose of recAP identified initially or placebo. The study completed recruitment with 301 patients, which makes it the largest interventional clinical study in AKI to date, the company noted in the release. The study was conducted in more than 50 ICUs in Western Europe and North America.
Although 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 during the 28-day study period. Throughout the study, safety data were regularly reviewed by an independent data safety monitoring board, without any observations of concern, the company reported.
Previously, the FDA granted fast track designation of recAP for the treatment of sepsis-associated acute kidney injury.