Bioactive Adrenomedullin, measured with sphingotec’s bio-ADM® assay plays a key role in septic shock patients as top-line results of AdrenOSS-2 Phase II Study indicate

• Bioactive Adrenomedullin is a biomarker for endothelial dysfunction and allows the prediction of septic shock as elevated blood levels of bio-ADM® predict blood pressure break down and blood vessel leakage resulting in edema
• AdrenOSS-2 Phase II trial shows that modulating the Adrenomedullin plasma level with the therapeutic antibody Adrecizumab demonstrates an improvement of survival in patients with septic shock
• Increased bio-ADM® levels were used as inclusion criteria in the AdrenOSS-2 Phase II trial to identify patients with endothelial dysfunction
• sphingotec to launch IB10 sphingotest® bio-ADM® a rapid immunoassay for bioactive Adrenomedullin on its Nexus IB10 point-of-care platform mid 2020

Hennigsdorf/Berlin, Germany, February 24, 2020 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf, Germany) today announced that data from the AdrenOSS-2 study indicate a modulating role of bioactive Adrenomedullin in septic shock. Topline results of the AdrenOSS-2 Phase II trial released on February 21, 2020 by its sponsor Adrenomed AG (Adrenomed) showed an increase in survival for patients with septic shock when treated with Adrecizumab. Adrecizumab targets bioactive Adrenomedullin and modulates endothelial function. Septic shock is the most severe form of sepsis, a medical emergency with high mortality. In the trial, blood levels of bioactive Adrenomedullin were measured with sphingotec’s quantitative bio-ADM® immunoassay as inclusion criteria.

Bioactive Adrenomedullin has been previously validated in over 22,000 patients as an endothelial function biomarker whose detection in the blood provides dynamic information on the patients’ progression in sepsis. High or rising blood levels of bioactive Adrenomedullin indicate a disbalance in the endothelial function leading to edema and shock while decreasing levels have been linked to improved patient outcomes. Based on this evidence, bioactive Adrenomedullin is not only a valid biomarker for endothelial function but was also qualified as a biotarget and led to the subsequent development of Adrecizumab, a therapeutic antibody to treat septic shock.

In the AdrenOSS-2 Phase II trial, which was designed to evaluate the safety, tolerability, and efficacy of Adrecizumab, increased bio-ADM® levels were used as an inclusion criterion to select those patients with septic shock, which have an endothelial dysfunction. The trial enrolled a total of 301 patients with septic shock and was carried out in multiple clinical trial centers in Belgium, France, Germany, and The Netherlands.

In this proof-of-concept trial, patients received Adrecizumab or placebo on top of standard of care treatment. The study achieved its primary endpoint: Adrecizumab demonstrated a favorable safety profile and was well tolerated. In addition, a lower all-cause mortality for Adrecizumab-treated patients was observed when compared to placebo.

AdrenOSS-2’ principal investigator Pierre-François Laterre commented: “Using bioactive Adrenomedullin blood levels as inclusion criteria allowed us to select the patients who have endothelial dysfunction. Measuring bioactive Adrenomedullin in a routine situation, furthermore allowed us to better understand the utility of this biomarker as a diagnostic tool as we saw that bioactive Adrenomedullin gave information on top of clinical standard parameters to assess patients’ severity. We will now go ahead to further investigate use-cases of bioactive Adrenomedullin as a biomarker in the clinical routine.”

Dr. Andreas Bergmann, founder and CEO of sphingotec commented: “Following our approach of diving deep into the biology of the disease, we have developed biomarkers that support clinicians in identifying the root causes of progression in sepsis. While the current trial indicates that using bioactive Adrenomedullin as a biomarker can help identifying those patients who could benefit in the future from Adrecizumab, the utility of this biomarker expands far beyond this and supports already today the early clinical decision making and monitoring of treatment success in sepsis.”

To support the critical care community in the timely assessment of endothelial function in sepsis and other acute and critical care conditions, sphingotec will launch IB10 sphingotest® bio-ADM®, a rapid test for bioactive Adrenomedullin that will be deployed on the company’s proprietary point-of-care platform, the Nexus IB10 immunoassay analyzer.