Sphingotec Therapeutics GmbH is a biopharmaceutical company with a clear mission: Improving heart function in order to improve survival. To achieve this mission we develop monoclonal antibody therapies to improve the outcome of acute diseased patients, such as patients with acute heart failure, myocardial infarction, cardiogenic shock and septic shock. Our lead products are a first-in-class drug candidate, the humanized monoclonal antibody PROCIZUMAB, and the respective companion diagnostic immuno assay.
Sphingotec Therapeutics was established in 2013 and is located in Hennigsdorf near Berlin, Germany. Managing Director Andreas Bergmann, Ph.D., is also CEO of Adrenomed AG, another biopharmaceutical company with a drug candidate targeting sepsis and CVDs.
Acute Heart Failure
Acute heart failure (AHF) is a relevant public health problem causing the majority of unplanned hospital admissions in patients age 65 years and above. Despite major achievements in the treatment of chronic heart failure (HF) over the last decades, which led to improvement in long-term survival, outcomes of AHF remain poor with 90-day re-hospitalization and 1-year mortality rates reaching up to 30%. Persistence of poor outcomes in AHF might be related to the paucity of improvements in the acute management of those patients. Despite lacking evidence of beneficial effects on outcome, acute treatment of AHF still mainly consists of non-invasive ventilation in case of pulmonary oedema, intravenous diuretics and/or vasodilators. These interventions are tailored according to the initial haemodynamic status with little regard to the underlying pathophysiological particularities.
Acute heart failure was historically described as a pump failure causing downstream hypoperfusion and upstream congestion. During the last decades a more complex network of interactions has been added to the simplistic haemodynamic model for explaining the pathophysiology of AHF. In addition, AHF is not a specific disease but the shared clinical presentation of different, heterogeneous cardiac abnormalities. Therefore, there is an unmet need for increased individualization of AHF treatment according to the predominant underlying pathophysiological mechanisms to, improve patient’s outcome.¹
Sphingotec Therapeutics offers a new approach to individualized treatment of acute heart failure – identification of AHF patients that show elevated biomarker levels to define susceptibility to certain treatments & a novel therapeutic approach with our monoclonal antibody PROCIZUMAB.
¹Arrigo M, Parissis JT, Akiyama E and Mebazaa A. Understanding acute heart failure: pathophysiology and diagnosis. European Heart Journal Supplements (2016) 18 (Supplement G), G11–G18.
Cardiovascular diseases (CVDs) are the leading cause of death in men and women. There is an unmet medical need for a reliable measure to determine the risk status, and to guide the success of prevention strategies as well as treatment strategies.
One part of our research focuses on the development of diagnostic tools. Using novel biomarkers gives us an aid in identifying patients that will benefit the most of the treatment.
In a screening to find targets in the treatment of heart failure by normalization of heart function, we identified a novel biomarker candidate that effectively predicts mortality in patients with cardiovascular failure and can be used to monitor the progress of the disease as well as indicate treatment strategies. This newly developed immunoassay can be used alone or in combination with PROCIZUMAB treatment.
PROCIZUMAB has an innovative mode of action, relevant in acute diseases that lead to massive cell death, which in turn leads to the uncontrolled release of intracellular proteins, e.g. peptidases. Such translocated peptidases can remain active in the circulation where they uncontrollably cleave bioactive peptides. Our antibody inhibits the activity of such an active translocated peptidase, thereby reducing bioactive peptide degradation, stabilizing cardiovascular functions and lowering mortality.
Preclinical studies of PROCIZUMAB in animal models of cardiovascular failure showed impressive efficacy instantly. As an example – injection of PROCIZUMAB in rats with shock-induced cardiovascular failure (low blood pressure, low shortening fraction) leads to an instant increase of blood pressure and normalization of shortening fraction (see videos).
Echocardiogram of rat heart with cardiovascular failure before PROCIZUMAB treatment
Echocardiogram of rat heart with cardiovascular failure after PROCIZUMAB treatment
PROCIZUMAB is a humanized murine monoclonal IgG1 antibody specifically binding a pathophysiological circulating peptidase. It will be a first-in-class drug that targets and modulates an essential regulator of cardiovascular function.
- High Preclinical Efficacy: In several cardiovascular failure models (mouse, rat), PROCIZUMAB has shown to improve all clinically relevant endpoints. It improves blood pressure, normalizes ejection fraction and reduces mortality.
- Excellent Safety: Toxicology & Safety studies in healthy rodents (rats) showed that PROCIZUMAB is well tolerated
- GMP material development ongoing: A generic Good Manufacturing Practice (GMP) process is under development
Andreas Bergmann, Ph.D. | Managing Director
Andreas Bergmann has worked in the diagnostic industry for over 30 years. With an outstanding track record, he has spearheaded the discovery, validation and the development of blood biomarkers. Bergmann was one of the founders and managers of B.R.A.H.M.S. AG where the sepsis marker Procalcitonin (PCT®) was developed under his responsibility as Chief Research Officer. Andreas Bergmann is inventor holding 204 patent rights and co-author of over 180 peer-reviewed scientific publications.
Dr. Bergmann went on to establish sphingotec GmbH and Sphingotec Therapeutics GmbH, which are located in Hennigsdorf. He leads the development of diagnostic methods for the prediction, prevention, intervention strategies and early treatment of diseases in the fields of cardiovascular diseases, cancer and acute care. Focusing on plasma biomarkers to indicate the susceptibility of a specific disease, the resulting information can enable monitoring, prevention and intervention strategies.
Dr. Bergmann is also Chief Scientific Officer (CSO) of the Adrenomed AG. Adrenomed is a biopharmaceutical company focussing on the discovery and development of monoclonal antibody therapies that target the vasoactive Adrenomedullin system as a new strategy for causative and safe treatment of acute circulatory failure, e.g. septic shock. Their lead product is the first-in-class drug candidate ADRECIZUMAB, a humanized monoclonal Adrenomedullin-specific antibody, which after successful completion of phase I clinical studies is now entering phase II.
Linda Rehfeld, Ph.D. | Scientific Director