Medical leaders back clinical utility of sphingotec's blood biomarker bio-ADM®

HENNIGSDORF, Germany, Feb. 15, 2019 /PRNewswire/ --

• New data presented by key opinion leaders in the field of congestive heart failure and shock prove that monitoring of sphingotec's blood biomarker, biologically active adrenomedullin (bio-ADM®), in critically ill patients significantly improve clinical decision making and outcomes
• bio-ADM® levels reliably identified both sepsis patients running into septic shock and allows differentiation of treatment responders and non-responders
• Elevated bio-ADM® levels identified heart failure patients with residual congestion or resistance to diuretics therapy, which both are major causes of re-hospitalization and post-discharge mortality of HF patients
• sphingotec will launch automated bio-ADM® testing on its NEXUS IB 10 point-of-care (POC) platform by H1/2019
• The NEXUS IB10 POC testing platform is suited to the needs of physicians at ICUs and emergency departments (EDs) and allows automatic testing of up to five acute care biomarkers in one run (time to result: 20 mins) for rapid on-site testing. 

German diagnostics company sphingotec GmbH (Hennigsdorf) reports that key opinion leaders have confirmed clinical utility of bio-ADM® (biologically active adrenomedullin), the company's proprietary marker for vascular leakage (endothelial dysfunction), in patients with congestion in heart failure and in patients with severe sepsis.

New clinical data presented at the 2nd Scientific Symposium on Endothelial Dysfunction in Berlin¹ by Prof. Dr. Alexandre Mebazaa (Paris) demonstrate that high bio-ADM® levels identified patients with acute heart failure that required immediate diuretics therapy because they were at high risk to develop lung edema. Furthermore, bio-ADM® levels above 45 pg/ml indicated congestion, both in acute heart failure and decompensated chronic heart failure. Data demonstrate that elevated bio-ADM® blood levels reliably identified residual congestion at discharge, a major cause of re-hospitalization and post-discharge mortality in heart failure patients, which physicians were unable to diagnose so far². Prof. Dr. Inder Anand (San Diego) reported that elevated bio-ADM® levels are a strong indicator of of 12-month mortality in patients with chronic heart failure. Data from Prof. Dr. Hans-Dirk Duengen (Charité, Berlin) proved that bio-ADM® reliably identified high-risk patients with worsening heart failure requiring immediate diuretics therapy to improve outcomes.

Further, clinical data presented in Berlin showed that rising bio-ADM® blood concentrations above 70 pg/ml precede septic and cardiogenic shock and helped improve outcomes by reducing the time to diagnosis and therapeutic intervention^3,4. In sepsis patients, falling bio-ADM® levels post-admission indicated a response to vasopressor therapy and survival while rising levels above the cut-off value correlated with blood pressure breakdown and thus with mortality. Data from clinical routine monitoring of bio-ADM® support findings from clinical studies that bio-ADM® is independent of inflammation and allows the monitoring of treatment success in patients with septic shock for early decision making in intensive care.

"bio-ADM® provides clinical utility by reducing the time to appropriate clinical decision making in both sepsis and in heart failure patients," said Prof. Dr. Salvatore Di Somma, University La Sapienza, Rome. "In septic shock, bio-ADM® is able to mirror the relaxation of vascular tone before the clinical signs of shock appear. In AHF patients the biomarker provides important information in therapeutic decision making in order to reduce mortality, length of stay in hospital and re-hospitalization rate," he added. Dr. Allan Jaffe from Mayo Clinic in Rochester added that the situation might further improve in the future if a therapeutic antibody (Adrecizumab by Adrenomed AG) becomes available that targets bio-ADM® in order to restore the impaired vascular barrier function.

sphingotec expects to launch bio-ADM® testing along with other innovative acute care biomarkers, to physicians at ICUs and EDs on its fully automated IB 10 point-of-care (POC) testing platform by mid-2019. Currently, more than 1,000 ICUs, emergency departments, smaller hospitals and larger practices in Europe and the Middle East use the IB 10 platform. This was acquired last summer by sphingotec from Samsung, to measure a panel of acute diagnostic blood biomarkers on a regular basis with more than 100,000 tests being performed per year.

"Backed by an €20m investment of HBM Healthcare Investments, HBM BioCapital II LP and Wellington Partners, we will push marketing of the IB 10 POC testing platform in 2019 to create a market monopoly for fully automated on-site testing of acute biomarkers at ICUs and EDs that support timely and valid clinical decision making," said Dr. Andreas Bergmann, CEO and founder of sphingotec GmbH.

[1] 2nd Scientific Symposium "Adrenomedullin as a diagnostic and therapeutic target", Berlin
[2] Voors et. a. (2018): Adrenomedullin in heart failure: pathophysiology and therapeutic application
[3] Mebazaa et al. (2018): Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis
[4] Geven et.al. (2018): Effects of adrenomedullin and the Anti-adrenomedullin antibody adrecizumab in sepsis

About sphingotec GmbH: sphingotec GmbH (Hennigsdorf, Germany) is developing and marketing innovative biomarkers such as penKid® and bio-ADM® 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, in addition, is 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.

A biomarker-assisted diuretics therapy in patients with congestive heart failure/cardio-renal syndrome by simultaneous measurement of bio-ADM® and penKid® targets lower re-hospitalization and mortality rates.

About penKid®: penKid® is the very first functional kidney marker that works in blood. penKid® is independent from comorbidities and inflammation and provides timely information about the changing kidney function in critically ill patients. sphingotest® penKid® is non-inferior to the gold standard in vivo measurement of glomerular filtration rate (GFR). These features enable physicians to diagnose and closely monitor worsening and improving kidney function in critically ill patients.

SOURCE sphingotec

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