Diagnostics company sphingotec GmbH reports novel applications of bio-ADM® (bio-active adrenomedullin), the very first biomarker capable to diagnose the onset of septic shock, allowing physicians earliest life-saving therapeutic interventions in sepsis critical care. At the 39th International Symposium on Intensive Care and Emergency Medicine (ISICEM, 19-22 March, 2019, Brussels), Prof Peter Pickkers (Radbound umc Nijmegen, The Netherlands) will report that bio-ADM® is used to select patients at high risk for septic shock for treatment with the antibody Adrecizumab (Adrenomed AG, Hennigsdorf, Germany), which is being evaluated in an ongoing Phase II study on patients with early septic shock.
bio-ADM® is the only biomarker capable of diagnosing endothelial dysfunction, which has been demonstrated to precede the life-threatening blood pressure break down that causes multi-organ failure, shock and death of sepsis patients at intensive care units (ICUs) and in emergency departments (EDs). In studies on more than 20,000 patients, high bio-ADM® plasma levels (>70pg/ml) have been shown to predict the onset of septic shock, 28-day mortality and vasopressor demand independently of co-morbidities or inflammation. Without bio-ADM® testing, norepinephrine administration is initiated about 3.1 ± 2.5 hours after the onset of septic shock. Every 1-hour of treatment delay is associated with a 5.3% increase in mortality. Early identification of patients running into shock will thereby statistically benefit one out of five septic shock patients (20%). As decreasing bio-ADM® levels have been linked to improved outcomes in clinical testing and pilot routine testing, bio-ADM® not only supports early clinical decision making but also monitoring of response to therapeutic intervention.
According to Pickkers, the further utility of bio-ADM® testing is provided by the selection of high-risk patients in clinical trials. Lack of stratification out of the highly heterogeneous sepsis population has been a major cause of failure in more than 60 late-stage trials with potential sepsis therapeutics in the past 20 years. Adrenomed AG is developing an antibody that leads to enrichment of bio-ADM® in the vessel lumen, where the vasoactive peptide hormone restores vascular integrity.
"It's a great advantage that we are able to improve patient enrichment using sphingotest® bio-ADM® in order to demonstrate the efficacy of Adrecizumab", commented Dr. Andreas Bergmann founder of both, sphingotec and Adrenomed, and CEO of sphingotec. "However, we should be aware that the diagnostic utility of bio-ADM® goes far beyond patient enrichment, as a single bio-ADM® measurement can exclude or diagnose endothelial dysfunction and thus assist critical care specialists to save lives in patients who most urgently need rapid therapeutic intervention." Dr.Bergmann is the co-founder of BRAHMS/ThermoFisher Scientific and co-inventor of procalcitonin, a sepsis diagnostic with an annual turnover of $600m. He is currently working to establish fully automated blood POC testing of bio-ADM® as well as establishing an innovative critical care biomarkers on the Nexus IB 10 platform, by summer 2019.