BioPorto Announces Appointment of National Principal Investigator and Selection of CRO for Upcoming USA ICU Adult AKI Clinical Study
October 10, 2024
News Release
BioPorto Announces Appointment of National Principal Investigator and Selection of CRO for Upcoming USA ICU Adult AKI Clinical Study
COPENHAGEN, Denmark and BOSTON, MA, USA, October 10, 2024 – BioPorto, a pioneering company in the field of diagnostic biomarkers, today announced selection of the Clinical Research Organization (CRO) and the appointment of a national Principal Investigator (PI) for their upcoming USA clinical study of Acute Kidney Injury (AKI) in adult patients which comprises an initial cut-off and a subsequent validation study.
The cut-off study, modeled on the successful pediatric indication for first day in the Intensive Care Unit (ICU), will enroll US patients with the goal of determining a cut-off point for risk stratification based on severe AKI.
BioPorto's ProNephro AKI™ (NGAL), currently cleared by the US Food and Drug Administration (FDA) for patients 3 months through 21 years of age, has been widely recognized for its groundbreaking potential in refining AKI diagnosis. The biomarker NGAL is a direct real-time marker of kidney cell damage and can potentially detect AKI days earlier than previously possible.
Leading Nephrologist from Massachusetts General Hospital Appointed Principal Investigator
Dr. Andrew Allegretti, MD, MSC of Massachusetts General Hospital, has been appointed PI for the adult study. Dr. Andrew Allegretti is the Director of Critical Care Nephrology and an Assistant Professor of Medicine at Harvard Medical School. His research has focused on Acute Kidney Injury in the ICU including specialty populations, chronic kidney diseases and cirrhosis/hepatorenal syndrome.
Dr. Allegretti notes, “As national PI, my role has three key components. First, to collaborate with BioPorto personnel and the CRO on the operational logistics of the study across sites. Second, to support clinical decision-making or changes within the study, should any arise. Third, to represent the study in the scientific community through presentations at congresses and in the regulatory community. I hope to be one of the first enrollment sites of the study.”
Highly Experienced CRO to Deliver Study Logistics
BioPorto has appointed ProPharma as its CRO based on their experience with IVDR projects and compatibility with BioPorto’s goals. Dr. Ute Feger notes, “We are pleased with the interest from clinicians to participate in this study and that with ProPharma as our partner, we can deliver excellent study logistics on the pathway to regulatory submission.”
BioPorto expects to enroll the first patient in the cut-off study in the fourth quarter of 2024, and to submit a clearance application on the adult indication by 2026.
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For further information
Jennifer Zonderman, BioPorto, +1 617 694 2918, [email protected]
Tim Eriksen, +45 4529 0000, [email protected]
Ashley Robertson, LifeSci Advisors, +1 617 430 7577, [email protected]
About Acute Kidney Injury
Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. AKI causes a build-up of waste products in blood and makes it difficult for kidneys to maintain the proper balance of bodily fluids. AKI can also affect other organs such as the brain, heart, and lungs and is common in patients who are in hospital intensive care units. For more information about AKI please visit: https://bioporto.com/aki/.
About BioPorto
BioPorto is an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers – tools designed to help clinicians make changes in patient management. The Company uses its expertise in antibodies and assay development, as well as its platform for assay development, to create a pipeline of novel and compelling products that focus on conditions where there is significant unmet medical need, and where the Company’s tests can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem.
The Company’s flagship products are based on the NGAL biomarker and designed to aid in the risk assessment and diagnosis of Acute Kidney Injury, a common clinical syndrome that can have severe consequences, including significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels which rise in relation to kidney injury, physicians can identify patients potentially at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The Company markets NGAL tests under applicable registrations including CE mark in several countries worldwide.
BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information visit http://www.bioporto.com.
