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JAMA publishes Phase II recAP data for sepsis-associated Acute Kidney Injury

AM‐Pharma, a biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (recAP) for inflammatory diseases, has published data in the prestigious Journal of the American Medical Association (JAMA) of its recently completed STOP-AKI Phase II study of recAP in the treatment of sepsis-associated Acute Kidney Injury (AKI). Simultaneously, the results were presented at European Society of Intensive Care Medicine in Paris. Additionally, new data on recAP’s mode of action were presented October 25th at the American Society of Nephrology Kidney Week in San Diego.

Professor Peter Pickkers, MD PhD, Chair of Experimental Intensive Care Medicine, Radboud University Medical Center, and principal investigator of the STOP-AKI study said: “Although the study did not meet its primary endpoint of short-term improvement in kidney function in the first 7 days, it did show long-term improvement in kidney function and very importantly a 40% relative reduction in mortality over placebo. In the absence of any drugs approved for this condition, these exciting clinical outcomes warrant further research to confirm these findings and to make this treatment available to patients.”

Prof. Pickkers is presenting the results of the randomized clinical study at today’s Hot Topics session at ESICM in Paris at 16:40 CET.

In addition, investigations at the institutions of Professor Mark D. Okusa and Professor Bruce Molitoris revealed more detail into recAP’s mode of action. Their research showed that protection from kidney injury is mediated by dephosphorylation by recAP of ATP to adenosine and activation of adenosine A2a receptors (A2aR).

Dr. Okusa, Professor of Medicine and Chief, Division of Nephrology and Director, Center for Immunity, Inflammation and Regenerative Medicine at University of Virginia, School of Medicine, and Dr. Molitoris, Professor of Medicine, former Director of Nephrology and the Indiana Center for Biological Microscopy at Indiana University noted: “The mode of action appears to be an elegant, double effect; in the first instance recAP inactivates pro-inflammatory ATP, and the resulting formation of adenosine further reduces inflammation through the immunosuppressive adenosine A2a receptor pathway.”

Professor Diane L. Rosin from Dr. Okusa’s research group will present the results at the annual meeting of the American Society of Nephrology in San Diego; Session Title: AKI: New Players and New Mechanisms, October 25th from 18:00 PT (session room 6D).

Erik van den Berg, CEO of AM-Pharma said: “We are excited to share the clinical trial results in JAMA and scientific conferences. We are now preparing for the pivotal study to confirm the STOP-AKI study results, which could have a significant impact on patients with Acute Kidney Injury, for whom there is currently no treatment available.”

Previously, the US Food and Drug Administration granted Fast Track designation for recAP for treatment of sepsis-associated AKI. AKI involves inflammatory processes in the kidney which can lead to complete loss of renal function and is associated with high mortality rates.

Source: AM-Pharma