- Positive EMA feedback on planned pivotal trial in septic shock
- Important step forward in global regulatory strategy for Adrecizumab
Hennigsdorf/Berlin (Germany), December 2, 2021 – Adrenomed AG, the vascular integrity company, today announced that it has received positive feedback from the European Medicines Agency (EMA) regarding the clinical development program for its lead product candidate, Adrecizumab (INN: enibarcimab). The first-in-class antibody targets the vasoprotective peptide adrenomedullin to restore vascular integrity in patients with early septic shock, a life-threatening condition with very limited treatment options.
In its scientific advice, EMA supports Adrenomed’s strategy to continue the development of Adrecizumab based on the completed Phase II trial AdrenOSS-2, which demonstrated favorable safety and tolerability and a positive survival trend. The planned pivotal trial is a biomarker-guided, multiregional, randomized, placebo-controlled study reflecting the precision medicine approach Adrenomed is pursuing with Adrecizumab. The trial will investigate Adrecizumab on top of standard of care in the treatment of intensive care unit (ICU) patients with early septic shock. The primary efficacy endpoint will be mortality according to the EMA guideline for the treatment of sepsis.
The study results will serve as the basis for the marketing authorization application for Adrecizumab in different regions. Further interactions with regulatory authorities are currently being prepared.
Dr. Jens Zimmermann, Chief Medical Officer at Adrenomed, said: “The EMA response is a positive signal and confirms the design of our forthcoming pivotal trial. The scientific advice strongly supports our plans and helps to pave the way for the further development of Adrecizumab.”
Adrenomed will be pleased to meet you at the
We will be attending the conference from Monday, January 10th through Thursday, January 13th and looking forward to seeing you.
Please contact Dr. Frauke Hein, Chief Business Officer of Adrenomed, to arrange a meeting.
Adrenomed AG is a German privately financed, clinical-stage biopharmaceutical company. Adrenomed’s mission is to rescue vascular integrity and save the lives of critically ill patients with limited treatment options. Founded in 2009 by a management team with decades of in-depth experience in sepsis and deep knowledge in diagnostics and drug development, the company’s lead product candidate Adrecizumab (INN: enibarcimab) is a first-in-class monoclonal antibody. Adrecizumab targets the vasoprotective peptide Adrenomedullin, an essential regulator of vascular integrity. Adrecizumab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock. For further information, please visit www.adrenomed.com and follow us on LinkedIn and Twitter.
Frauke Hein, Ph.D. (Chief Business Officer)
phone: +49 (0)3302 207780
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Eva Bauer / Julia von Hummel
phone: +49 (0)89 21022880