- Data from more than 20,000 patients show that bio-ADM® adds value to clinical decision-making at ICUs and EDs because it is the only biomarker
that allows early prediction of septic shock
- bio-ADM® allows starting life-saving interventions such as early
administration of vasopressors which will benefit about 20% of sepsis patients
- bioADM® is used for patient selection in an ongoing phase II trial with
therapeutic antibody Adrecizumab
- bio-ADM® POC test for rapid decision-making at ICUs and EDs will be
launched by H1/2019
19 March 2019. Hennigsdorf/Berlin – 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. Xiaowu Bai et al., Early vs delayed administration of epinephrine in patients
with septic shock. Critical Care 18: 532
About SphingoTec GmbH: SphingoTec GmbH (Hennigsdorf, Germany) is developing and marketing innovative biomarkers such as penKid® and bioADM® for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock, as well as the Nexus IB10 POC testing immunoassay platform acquired from Samsung-subsidiary Nexus Dx Inc. in May 2018. The company, founded by Dr. Andreas Bergmann in 2002, is additionally developing a pipeline of novel biomarkers which can predict the risks of obesity, breast cancer and cardiovascular diseases.
About bio-ADM®: As a marker of vascular integrity, bio-ADM® enables both predictions of circulatory shock 48 h before blood pressure breakdown, e.g. in septic patients, and diagnosis of diuretic-resistant congestion in acute heart failure patients.