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Biomarker-guided trial led by University Hospital Hamburg-Eppendorf (UKE) opens new avenues for personalized medicine for treatment of COVID-19.
SphingoTec, a German diagnostics company, announced on April 11, 2022 the implementation of two critical care biomarkers to guide the application of a potential new drug candidate for the treatment of COVID-19 patients. The trial will be led by University Hospital Hamburg-Eppendorf (UKE).
The trial will evaluate one of the first personalized approaches to treat moderate to severe COVID-19 with the drug candidate Adrecizumab (HAM8101; INN: enibarcimab) (1). The trial will use bioactive adrenomedullin (bio-ADM) as a biomarker to help with the early identification of endothelial dysfunction, a condition that has been shown to play a central role in the pathophysiology of COVID-19. Adrecizumab can then target high levels of bio-ADM in patients who have gone into septic shock. The use of this drug candidate has already shown favorable outcomes in a case series of eight severe COVID-19 patients.
The second biomarker in the trial will be dipeptidyl peptidase 3 (DPP3); but in this case, the second biomarker will be used to identify and exclude patients who exhibit high levels of DPP3. This is because DPP3 indicates that there is another underlying disease mechanism existing within the patient that can lead to cardiac depression. In that case, that patient would require a different therapeutic option than the Adrecizumab used in the trial. Both bio-ADM and DPP3 levels will be measured using SphingoTec’s rapid point of care platform Nexus IB10.
“Not all COVID-19 patients have the same disease course, and the pathology is very different,” said PD Dr. med. Mahir Karakas, part of the Department of Intensive Care Medicine at UKE. “Therefore, we have to adapt the treatment to each individual patient. We will now use in a double blind randomized multicenter trial the biomarker bio-ADM and DPP3 which proved to be useful for patient enrichment in a Phase II trial for treatment of septic shock.”
“The innovative biomarkers generate better insights into the pathophysiology of critically ill patients,” added Dr. Andreas Bergmann, founder of SphingoTec and co-founder of Andrenomed. “This is translated into clear decisions that allow a better treatment guidance and ultimately reduce mortality. This study represents a leap from “one drug fits all” to a personalized approach in treating COVID-19.”
1. Adrenomed, “Research & Development,” adrenomed.com, accessed April 11, 2022.