26 January 2022
AM-Pharma and Leading Experts Publish Report on State-of-the-Art Clinical Trials in Acute Kidney Injury
Utrecht, The Netherlands, January 26, 2022 – AM Pharma B.V., an emerging leader focused on developing therapeutics for severe medical conditions, today announced that its Chief Operating Officer, Juliane Bernholz, PhD, is among the authors of a recently published peer-reviewed article discussing the design and implementation of clinical trials for Acute Kidney Injury (AKI). With representation from a large group of leading medical, academic, industry and government organizations including University of California, San Francisco; University of California, San Diego; University of Pennsylvania Perelman School of Medicine; Lerner College of Medicine of Case Western University; Cleveland Clinic; Bayer Pharmaceuticals; University of Michigan; Johns Hopkins School of Medicine; Verpora Ltd.; National Institutes of Health; University of Washington, INI-CRCT Network; and the University of Lorraine, France, the article, titled “Overcoming barriers in the design and implementation of clinical trials for Acute Kidney Injury: a report from the 2020 Kidney Disease Clinical Trialists meeting” was published in the journal Nephrology Dialysis Transplantation (NDT).
The article provides insights on important advances in the understanding of AKI as a disease spectrum with an urgent need for new treatments. The increase in clinical experience with randomized-controlled trials has provided data on effective strategies for patient inclusion and prognostic enrichment. Of note, the article discusses the knowledge gained from AM-Pharma’s Phase IIa/b clinical study STOP-AKI as well as the design and implementation of the company’s ongoing Phase III REVIVAL trial study evaluating the efficacy and safety of AM-Pharma’s proprietary recombinant alkaline phosphatase, ilofotase alfa, for the treatment of patients with sepsis-associated-AKI.
“AKI represents a critical need in medicine that has become more pressing through the current pandemic. Sharing knowledge that can support effective clinical trial design is an important step toward bringing innovative treatments to patients,” stated Mathieu Legrand, MD, PhD, Professor in Residence, Department of Anesthesia & Perioperative Care, Division of Critical Care Medicine, University of California San Francisco (UCSF) and lead author on the publication. “I thank this group of esteemed experts for working together to make this publication possible.”
“It was an honor to bring AM-Pharma’s experience into this publication and gain further insights from a consortium of authors from premier hospitals, medical schools, industry and government institutes. As we continue REVIVAL, we look forward to upcoming data of how ilofotase alfa may improve the treatment of sepsis-associated AKI,” added Juliane Bernholz, PhD, COO of AM-Pharma.
Nephrology Dialysis Transplantation: an international basic science and clinical renal journal (ndt) is the leading nephrology journal in Europe and renowned worldwide, devoted to original clinical and laboratory research in nephrology, dialysis, and transplantation. ndt is an official journal of the ERA (European Renal Association). Published monthly, the journal provides an essential resource for researchers and clinicians throughout the world.
AM-Pharma’s purpose is to save and improve the lives of patients confronted with severe medical conditions. Our initial focus is sepsis-associated acute kidney injury, the cause of death for hundreds of thousands of people hospitalized each year. Our proprietary compound, ilofotase alfa, has the potential to become the first treatment for sepsis-associated acute kidney injury and is now in a global pivotal Phase III clinical trial. We are a dedicated team driven to bring treatment options to severely ill patients, their families and acute care professionals. Find out more about us online at: www.am-pharma.com.