Adrenomed to Present New Topline Data from AdrenOSS-2 Trial in Virtual Meeting hosted by Sepsis Comprehensive Center Charité

16. March 2020

  • The meeting “Global Burden, Diagnosis, and Adjunctive Therapies of Sepsis and COVID-19” will be available via livestream today, March 16, at 5:00 pm CET
  • Adrenomed recently announced positive topline data from its AdrenOSS-2 Phase II trial in sepsis

Hennigsdorf/Berlin (Germany), March 16, 2020 – Adrenomed AG, the vascular integrity company, announces the presentation of topline data from the AdrenOSS-2 Phase II trial in an event hosted today, March 16, 2020, at 5:00 pm CET by the newly established interdisciplinary Sepsis Comprehensive Center Charité (SCCC).

Prof. Alexandre Mebazaa, MD, PhD, Chair of Department of Anesthesiology and Critical Care in Paris at the Hôpital Lariboisière, Université de Paris (France), and member of the AdrenOSS-2 Steering Committee, will speak about “Adrecizumab – Targeted Treatment of Endothelial Dysfunction in Sepsis: Results from the AdrenOSS-2 Phase II Trial”.

In light of the measures currently taken to contain the spread of the coronavirus, the event will be held online. A livestream can be viewed via the following link: https://www.global-sepsis-alliance.org/chariteevent; a registration is not required.

Please refer to the event website for detailed information on the program.

AdrenOSS-2 evaluated the safety, tolerability and efficacy of Adrecizumab, a first-in-class mono­clonal antibody targeting the vasoprotective peptide Adrenomedullin to restore and maintain vascular integrity in patients with early septic shock. Septic shock is a life-threatening condition with very limited treatment options. Sepsis is the main cause of death in hospitals worldwide.[i]

The biomarker-guided, randomized, international, multicenter, double-blind, placebo-controlled AdrenOSS-2 Phase II trial (NCT03085758[ii]) enrolled a total of 301 patients with early septic shock and elevated blood levels of bio-ADM® throughout Belgium, France, Germany and The Netherlands.[iii] In addition to standard of care, patients received Adrecizumab or placebo. Coordinating investigators for each involved country and chairpersons of the Steering Committee are Prof. A. Mebazaa, France, Prof. P.F. Laterre, Belgium, Prof. G. Marx, Germany and Prof. P. Pickkers, The Netherlands.

Detailed data from the AdrenOSS-2 study will be submitted for publication in a peer-reviewed journal later this year.

About Sepsis and Septic Shock
Sepsis is a life-threatening condition that results in organ dysfunction caused by a dysregulated host response to infection. Septic shock is the most severe form of sepsis characterized by a rapid fall in blood pressure requiring vasopressor treatment; profound circulatory, cellular and metabolic abnormalities; diminished oxygen supply to organs and finally, multiple organ failure. Septic shock is driven by severe loss of vascular integrity: a breakdown of the endothelial barrier, which results in uncontrolled leakage of intravascular fluid and other compounds into the extravascular space leading to congestion and edema.

Today, sepsis and septic shock are major healthcare problems, representing a high unmet medical need affecting millions of people around the world every year. In the United States, sepsis causes or contributes to between one-third and one-half of all deaths occurring in hospitals. With an unacceptably high mortality rate,1 sepsis represents an enormous public health burden. The current standard of care for sepsis patients is based on early treatment with antibiotics and administration of fluids and vasopressors (hemodynamic support).

About Adrecizumab and Adrenomedullin[iv]
Adrenomedullin (ADM) is a free-circulating peptide that is mainly expressed and secreted by vascular endothelial cells. It shows vasoprotective activity inside blood vessels, where it closes the gaps between endothelial cells, subsequently preventing intravascular fluid and other compounds from uncontrolled leakage into the interstitium/extravascular space (= vascular leakage). In the interstitium, however, ADM has vasodilatory properties and causes hypotension when present in higher concentrations, which, in sepsis patients, leads to worsening and progression of the disease. Adrenomed’s first-in-class drug candidate, Adrecizumab, targets bioactive Adrenomedullin (bio-ADM) to restore endothelial barrier function (= vascular integrity). Binding of the monoclonal antibody Adrecizumab to ADM in the blood traps and stabilizes the peptide-hormone, resulting in increased ADM concentrations within the blood vessels. The complex of ADM and Adrecizumab in the blood is still active. This way, Adrecizumab treatment boosts ADM’s protective effects on the endothelial barrier.

About Adrenomed
Adrenomed AG is a German privately financed, clinical-stage biopharmaceutical company. Adrenomed’s mission is to rescue vascular integrity in order to 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 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.

Contact
Adrenomed AG
Frauke Hein, Ph.D. (Chief Business Officer)
phone: +49 (0)3302 2077814
fhein@adrenomed.com

Media Inquiries
MC Services AG
Eva Bauer / Julia von Hummel
phone: +49 (0)89 21022880
adrenomed@mc-services.eu

[i]     JAMA, 2014;312(1):90-9
[ii]     clinicaltrials.gov/ct2/show/NCT03085758?term=NCT03085758&rank=1
[iii]    BMJ Open, 2019;9:e024475
[iv]    Shock, 2018;50(6):648-654