- Comprehensive clinical safety review of Adrecizumab to be presented
- Opinion leaders will discuss effects of Adrecizumab and its target Adrenomedullin on septic shock mortality in four sessions
- Adrenomed expects to start enrolment for Phase II Proof-of-concept study In Q4/2017
Hennigsdorf/Berlin (Germany) September 25, 2017 – Adrenomed AG (Hennigdorf, Germany) today announced publication of two abstracts accepted for the European Society of Intensive Care Medicine (ESICM) conference taking place on September 23 – 27, 2017 in Vienna. In addition to comprehensive safety data from Phase I testing of Adrenomed’s lead candidate Adrecizumab and mechanistic details how it ameliorates septic shock mortality, opinion leaders will discuss new data relating to Adrecizumab’s target, the vaso-active hormone adrenomedullin, in four sessions.
„We are delighted to share additional insight with the scientific community concerning the progress of our lead candidate Adrecizumab, an antibody designed to reduce mortality of septic shock through targeting of the vasoactive peptide hormone adrenomedullin,” said Dr Andreas Bergmann, Chief Scientific Officer (CSO) of Adrenomed. „We look forward to enrolling the first patient in the Phase II ADR-02 study in Q4/2017.“
In the session „Sepsis: Therapies in Pipeline“, Prof. Konrad Reinhart, Chair of the Global Sepsis Alliance, will summarize data demonstrating that targeting of the vasoactive hormone Adrenomedullin must be highly selective to have an effect on septic shock mortality. Selective absorption of active Adrenomedullin into the blood plasma without boosting production of the peptide hormone in smooth muscle cells is required to prevent vascular leakage and vasodilation, hallmarks of septic shock, which lead to organ failure and mortality. In the session „State of the Art in Sepsis Management: Sepsis Therapeutics“, Reinhart will discuss the impact of selective targeting of Adrenomedullin by Adrecizumab versus standard treatment approaches.
In two sessions, Dr Christopher Geven from Radboud University Medical Center, Department of Intensive Care Medicine, Nijmegen, Netherlands, lead investigator of the Phase 1 studies that was conducted with different dose levels of Adrecizumab in healthy volunteers (n=24), will present detailed safety data. Adrecizumab was well tolerated and showed an excellent safety profile. No severe adverse events occurred. Study drug administration did not result in relevant changes in vital signs and electrocardiographic evaluations. Furthermore, Adrecizumab showed an expected low clearance rate and a typical pharmacokinetics. In an additional session, Geven will present data underscoring Adrecizumab’s mode of action. Reduction in vascular leakage and mortality by a single injection of Adrecizumab was mediated in vivo through increased plasma levels of active adrenomedullin while levels of the pro-hormone produced in smooth muscle cells did not increase.
The full abstracts can be accessed online at
Adrenomed AG is a privately financed biopharmaceutical company, based in Hennigsdorf near Berlin, Germany, with a clear mission to improve survival by improving vascular integrity in critically ill patients. Its lead candidate, Adrecizumab, a monoclonal antibody therapy targeting the vasoactive adrenomedullin system, is in clinical testing for early septic shock. Impaired vascular integrity is a pathology that serves a variety of medical conditions. A further indication besides sepsis is acute decompensated heart failure.
Adrenomedullin is a strong vasodilatory hormone released by endothelial cells. It is a key regulator of blood pressure and vascular tone and plays a pivotal role in the development of septic shock.
Adrecizumab is a proprietary humanized monoclonal Adrenomedullin-specific antibody, as first-in-class therapy for the treatment and prevention of impaired vascular integrity, which is a hallmark of septic shock. Adrecizumab showed excellent safety & tolerability as well as high efficacy in a variety of preclinical animal models, mimicking human standard of care treatment on ICU. In several resuscitated vascular integrity models (mouse, rat, pig), Adrecizumab reduced vascular leakage, stabilized the circulation, by restoring blood pressure, normalized fluid balance and reduced vasopressor demand, improved renal function and reduced mortality from septic shock by 50%. The excellent tolerability and safety of Adrecizumab was confirmed in clinical Phase-I studies in healthy subjects with and without LPS challenge.
Early septic shock
is defined as a life-threatening organ dysfunction due to dysregulated host response to a proven or suspected infection which leads to a decline of Mean Arterial Pressure (MAP) < 65 mmHg, which is refractory to fluid resuscitation and requires vasopressors. Early is defined as a maximum of less than 12 hours between onset of the cardiovascular organ-dysfunction and administration of Adrecizumab. Refractoriness to fluid resuscitation is defined as a lack of response to the administration of 30 mL of fluid per kilogram of body weight or is determined according to a clinician’s assessment of inadequate hemodynamic results.
Dr. Frauke Hein
Phone: + 49 3302 2077814