Sepsis: Adrenomed receives approval for POC study in patients with early septic shock

German corporation Adrenomed AG has received the favorable opinion of the Central Ethics Committee of the University of Aachen for its Phase-II study ADR-02 (AdrenOSS-2), a randomized, double-blind, multi-center study, which will recruit 300 patients with early septic shock in Germany, Belgium, France and the Netherlands. Together with the approval of the German regulatory authority Paul Ehrlich Institute (PEI), received in July 2017, the ADR-02 study is expected to  be started by September in Germany.

In this proof-of-concept (POC) study, Adrenomed aims to demonstrate that its human monoclonal antibody Adrecizumab is safe and well tolerated and can improve outcomes in patients with early septic shock who show increased levels of the targeted vascular biomarker bio-adrenomedullin. Adrenomedullin, a vasodilatory hormone released by endothelial cells, is a key regulator of blood pressure and vascular tone and plays a pivotal role in the development of septic shock.

„We are delighted that the Paul Ehrlich Institute has granted approval for the ADR-02 study as it is the next crucial step to demonstrate that Adrecizumab has the potential to reduce the high mortality rates from sepsis,“ said Andreas Bergmann, PhD., Chief Scientific Officer (CSO) of Adrenomed. „Sepsis affects millions of people globally. To date, there is no causative treatment for the systemic inflammation that leads to multi-organ failure.“

In preclinical studies Adrecizumab reduced mortality from sepsis and septic shock. In addition, Adrecizumab positively impacted the vasoactive adrenomedullin system leading to stabilisation of blood pressure and renal function. Two Phase-I studies demonstrated excellent tolerability and safety of Adrecizumab without any severe adverse effects (NCT02991508, NCT03083171).