AM-Pharma receives FDA fast track designation for recAP in Acute Kidney Injury, and reports completion of first stage in Phase II trial
Trial on track and FDA regulatory status may allow accelerated patient access to new drug
Bunnik, The Netherlands, 26 April 2016. 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.
The fast track designation helps facilitate the development and expedite the review process of drugs designed to treat severe conditions and fulfill an unmet medical need.1 This status also enables a continuous dialogue with the FDA on the clinical and regulatory development of recAP.
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.
“Both the fast track designation and the completion of the interim analysis indicate the positive progress of recAP and potentially shorten the time to bring the product to patients,” said Erik van den Berg, CEO of AM-Pharma. “We look forward to continuing our interactions with the regulatory agencies for fast development of recAP to address this unmet medical need in Acute Kidney Injury.”
