AM-Pharma announced that the Food and Drug Administration (FDA) has granted Fast Track designation to recAP (recombinant human Alkaline Phosphatase) for the treatment of acute kidney injury (AKI).
The recombinant form of human Alkaline Phosphatase (recAP) is currently in Phase 2 development for sepsis-associated AKI. An interim analysis on the first stage of the Phase 2 trial has been successfully completed by an independent data monitoring committee. The first stage of the study is designed to select the best of 3 doses of recAP in AKI. The second stage will recruit additional patients to evaluate the selected recAP dose compared to placebo. Full results of the study are expected in 2017.
AM-Pharma’s investigational candidate, recAP, is a proprietary recombinant human AP constructed from two naturally occurring, highly stable human isoforms of the AP enzyme. It is under clinical development for the treatment of AKI, ulcerative colitis (UC), and hypophosphatasia (HPP).
For more information visit Am-Pharma.com.