Septic shock innovative therapy! The second phase of adrecizumab concept verification was successful, targeting the recovery of adrenomedullin & maintaining vascular integrity!

February 25, 2020 news / BIOON / -- advanced AG is a clinical stage biopharmaceutical company in Germany It was founded in 2009 by a management team with decades of in-depth experience in sepsis and deep knowledge of diagnosis and drug development It is committed to saving the lives of critically ill patients with limited treatment programs by protecting the integrity of blood vessels Its leading candidate, adrecizumab, is a first-in-class monoclonal antibody, which can restore and maintain vascular integrity by targeting the vasoprotective peptide, adrenomedullin (ADM) ADM is an important regulator of vascular integrity Adrecizumab can regulate the plasma level of bio Adm Recently, the company released the positive top line results of phase II clinical trial (nct030857583) of concept validation of adrenoss-2 This study evaluated the safety, tolerance and effectiveness of adrecizumab in the recovery and maintenance of vascular integrity in patients with early septic shock Septic shock is a life-threatening infection, and the treatment options are very limited Sepsis is the main cause of hospital death worldwide This study is a biomarker guided, randomized, international, multicenter, double-blind, placebo-controlled phase II trial 301 patients with early septic shock were enrolled in Belgium, France, Germany, and the Netherlands These patients had elevated blood bio amd levels In the study, patients were randomly assigned to receive advecizumab or placebo while receiving standard care The results showed that the study reached the main end point: adrecizumab showed good safety and tolerance The safety and tolerance of adrecizumab in patients with septic shock were consistent with those observed in previous phase I trials In addition, in the 28 day follow-up, the mortality rate in the placebo group was 28%, and the trend of all-cause mortality rate in the adrecizumab treatment group was lower than that in the placebo group Detailed data from the study will be published in peer-reviewed journals later this year "These are very promising results and consistent data," said Dr Jens Zimmermann, chief medical officer of the company The results of the adrenoss-2 trial showed that adrecizumab was beneficial to septic shock patients By restoring and maintaining vascular integrity, adrecizumab may represent a new treatment option for septic shock " Sepsis is a life-threatening disease, which is caused by the host's maladjusted response to infection Septic shock is the most serious type of sepsis, which is characterized by rapid drop in blood pressure, need of vasopressin treatment, serious circulatory, cellular and metabolic abnormalities, organ oxygen supply reduction, and finally multiple organ failure Septic shock is caused by severe loss of vascular integrity: destruction of the endothelial barrier, uncontrolled leakage of intravascular fluid and other compounds into the extravascular space, leading to congestion and edema At present, sepsis and septic shock are important medical problems, representing a highly unmet medical demand, affecting millions of people around the world every year In the United States, sepsis causes or contributes to one-third to half of hospital deaths Due to the unacceptably high mortality rate, sepsis is a huge public health burden At present, the standard of care for patients with sepsis is based on early antibiotic treatment, the use of fluids and vasopressors (hemodynamic support) Adrenomedullin (ADM) is a kind of free circulating peptide mainly expressed and secreted by vascular endothelial cells, which shows vasoprotective activity in the blood vessels, closes the gap between endothelial cells, and then prevents the fluid and other compounds from uncontrolled leakage into the interstitial / extravascular space (= vascular leakage) However, ADM has vasodilation property in interstitial tissue, which will cause hypotension when the concentration is high, which will lead to the progress and deterioration of the disease in sepsis patients Adrecizumab is the first in class drug candidate of advanced company, targeting biologically active adrenomedullin (bio ADM) to restore endothelial barrier function (= vascular integrity) The combination of adrecizumab with ADM in the blood can capture and stabilize this peptide hormone, which leads to the increase of ADM concentration in the blood vessel and the restoration and maintenance of vascular integrity The complex of ADM and advecizumab in blood is still active In this way, adrecizumab treatment enhanced the protective effect of ADM on endothelial barrier Original source: Advanced announcements positive top-line advisors-2 phase II results with adaptive in selective shop