AM‐Pharma B.V., a biopharmaceutical company focused on the development of recAP (recombinant human Alkaline Phosphatase) for inflammatory diseases, announces that it has received fast track designation from the U.S. Food and Drug Administration (FDA) for recAP to treat Acute Kidney Injury (AKI). Additionally, the Company reports that the interim analysis on the first stage of the adaptive Phase II trial in AKI has been successfully completed.
Within the Phase II study, an independent data monitoring committee has completed its interim analysis of the first 120 patients recruited to the trial. The outcome is the selection of the best of the three doses that were investigated in the first stage of the study. In the second stage of the clinical trial, an additional 170 patients will be recruited in two arms of 85 patients each, where patients will receive either the selected recAP dose or placebo.
The study is the largest to date investigating treatment of AKI, and will recruit a minimum of 290 patients in more than 70 sites across Western Europe and North America. Results from the study are expected in 2017.
