Netherlands-based biopharmaceutical company AM-Pharma has received fast track designation from the US Food and Drug Administration (FDA), for recombinant human Alkaline Phosphatase (recAP) to treat Acute Kidney Injury (AKI).
The fast track designation received by the company not only helps in the development, but also quickens the review process of drugs that are developed to treat severe conditions, as well as to address an unmet medical need.
This status also allows a continuous dialogue with the FDA on the clinical and regulatory development of recAP.
Apart from receiving fast track designation, AM-Pharma has also completed the interim analysis on the first stage of the adaptive Phase II study in AKI.
As part of the Phase II trial, an independent data monitoring committee has conducted its interim analysis of the first 120 patients included in the trial.
With the successful completion of the analysis, the best of the three doses that were examined in the first stage of the trial has been selected.
As part of the second stage of the clinical study, another group of 170 patients will participate in the trial where they will be divided into two groups of 85 patients each.
The trial will include at least 290 patients in more than 70 sites across Western Europe and North America, who will be treated with selected recAP dose or placebo.
With results expected in 2017, the study is the largest investigating treatment of AKI conducted so far.
AM-Pharma CEO Erik van den Berg said: "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.
"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."
AM-Pharma focuses on the preclinical and clinical development of recAP as a treatment for AKI, as well as Ulcerative Colitis (UC) and Hypophosphatasia (HPP).
Image: AM-Pharma to use recap for treating Acute Kidney Injury. Photo: courtesy of Haymanj.