Adrenomed’s Adrecizumab successfully passes interim analysis in early septic shock study AdrenOSS-II
AdrenOSS-II trial continues as planned after positive interim efficacy analysis triggered by the treatment of 50% of randomized patients Proof-of-concept trial design testing Adrecizumab in
Hennigsdorf (Germany), March 12, 2019 – Adrenomed AG, the vascular integrity company, announced today its participation in three upcoming conferences in Europe. Adrenomed representatives
Ongoing proof-of-concept trial AdrenOSS-II testing Adrecizumab in early septic shock Adrecizumab is a first-in-class antibody targeting Adrenomedullin, to rescue vascular function Vascular integrity, regulated by
Adrenomed AG is a privately-financed, clinical-stage biopharmaceutical company with a clear mission: to rescue vascular integrity in order to save the lives of critically ill patients with limited treatment options.
The Company’s lead product candidate is Adrecizumab, a clinical-stage, first-in-class monoclonal antibody. Adrecizumab targets the vasoprotective peptide Adrenomedullin, an essential regulator of vascular integrity to treat life-threatening conditions associated with increased vascular leakage, congestion and shock.
Our unique treatment approach combines the therapeutic antibody with a specific diagnostic, which uses Adrenomedullin as the biomarker to identify patients. The most important target indications are sepsis and septic shock as well as acute heart failure.
Adrenomed’s business is effectively secured by a strong IP position with granted patents in all major markets.
Adrenomed is based in Hennigsdorf near Berlin, Germany.
Adrenomed was established in 2009 after the successful trade sale of the B·R·A·H·M·S AG to Thermo Fisher. The co-founders and executive managers of the B·R·A·H·M·S AG were Dr. Andreas Bergmann, who serves today as CSO of Adrenomed; also Dr. Bernd Wegener and Dr. Metod Miklus, who today are members of Adrenomed’s Supervisory Board. At B·R·A·H·M·S AG they changed the standard of care in sepsis by developing Procalcitonin (B·R·A·H·M·S PCTTM), the diagnostic gold standard sepsis biomarker.
Adrenomed’s vision is to translate the concept of personalized medicine into acute care. Consequently, Andreas Bergmann, in his dual role as CSO of Adrenomed and CEO of sphingotec GmbH, connects the diagnosis of acute medical conditions, for example sepsis and acute heart failure, with the therapeutic approaches developed by Adrenomed.
The extensive in-depth work in sepsis, diagnostics and drug development led to well-established contacts with key opinion leaders worldwide in cardiovascular disease and sepsis that support Adrenomed’s clinical research.
Board of Directors
Dr. Gerald Moeller
Chief Executive Officer (CEO)
Dr. Gerald Moeller, Chief Executive Officer (CEO) of Adrenomed since 2018, has a long-standing track record in the diagnostics and pharmaceutical industry, in venture capital and in capital markets. He served as CEO at Boehringer Mannheim and member of the Executive Committee of Roche, chairman in the MorphoSys supervisory board and as an Investment Advisor to HBM Partners, Switzerland.
Dr. Andreas Bergmann
Chief Scientific Officer (CSO)
Dr. Andreas Bergmann, co-founder and Chief Scientific Officer (CSO) of Adrenomed and CEO of sphingotec GmbH, has deep knowledge and experience with the disease biology and diagnosis of sepsis. As inventor of more than 100 patents and co-founder & former executive manager of B·R·A·H·M·S AG, he helped to change the standard of care in sepsis by developing Procalcitonin, the diagnostic gold standard sepsis biomarker.
Dr. Jens Zimmermann
Chief Medical Officer (CMO)
Dr. Jens Zimmermann, Chief Medical Officer (CMO), has served as a member of the management team for Adrenomed since 2017. By training, Dr. Zimmerman is physician and biochemist and an experienced clinical operations and medical affairs executive. He participated in the development and US/EMA approval of icatibant in Hereditary Angioedema (HAE) and pirfenidone in Idiopathic Pulmonary Fibrosis (IPF). Dr. Zimmerman is former Medical Director at Vanda Pharmaceuticals, and he also held senior medical positions at Roche, InterMune, Pfizer, Shire, Jerini and Berlin-Chemie.
Dr. Frauke Hein
Chief Business Officer (CBO)
Dr. Frauke Hein, co-founder and long-standing member of the Adrenomed management team, serves as Chief Business Officer (CBO). Previously, Dr. Hein held the position as Director R&D at B·R·A·H·M·S AG and Thermo Fisher, where she was responsible for strategic planning, R&D alliance and portfolio management. She is former Director Life Sciences ZAB, responsible for start-up financing and R&D grant evaluation in Berlin-Brandenburg.
Dr. Joachim Struck
Head of Research & Development
Dr. Joachim Struck is co-founder of Adrenomed and serves as Head of R&D since 2013. Before joining Adrenomed, he started his industrial career in 1991 at Henning Berlin GmbH (later B·R·A·H·M·S AG and Thermo Fisher Scientific). There, he developed several immunoassays and was responsible for discovery and clinical profiling of novel biomarkers as well as IP development. He is co-inventor of more than 50 patent families and is co-author of more than 150 peer-reviewed scientific publications. Since recently, he also acts as VP Medical Affairs at sphingotec GmbH.
Dr. Bernd Wegner (Chairman)
Co-founder of Adrenomed with over 35 years of management experience in the diagnostic and pharmaceutical Industry
Dr. Priyanka Belawat
Investment Advisor at HBM Partners
Dr. Ute Kilger
Partner at Boehmert & Boehmert
Dr. Metod Miklus
CEO of ExpoCapital GmbH and co-founder of B·R·A·H·M·S AG
Dr. Rainer Strohmenger
Managing Partner at Wellington Partners
Adrenomed is dedicated to save the lives of critically ill patients by translating the concept of personalized medicine to acute care. We are targeting Adrenomedullin, a peptide hormone with protective effects on endothelial barrier integrity. With a biomarker-drug combination utilizing the target as biomarker for patient stratification, Adrenomed develops a unique, holistic approach to rescue vascular integrity in life-threatening conditions such as sepsis, septic shock and acute heart failure.
The Company’s lead product candidate is Adrecizumab, a clinical-stage, first-in-class drug targeting loss of vascular integrity. The strong rationale for Adrecizumab is supported by the elegance of its mode of action, a monoclonal antibody that on binding to its target Adrenomedullin preserves its functionality as regulator of vascular integrity.
Suitability of using Adrecizumab to treat loss of vascular integrity is based on evidence obtained in multiple preclinical intensive care-like vascular integrity models with Adrecizumab applied on top of mimicked human standard of care treatment (e.g. fluids, vasopressors).
Adrecizumab treatment significantly improved all clinically relevant endpoints such as reduction of vascular leakage and vasopressor demand, stabilization of the circulation, normalization of fluid balance and kidney function. In preclinical septic shock models, Adrecizumab reduced the mortality by 50% (Intens Care Med Exp, 2013; Intens Care Med, 2013; Shock, 2018).
Furthermore, Adrenomedullin was validated as therapeutic target and biomarker in thousands of well-defined patients’ samples in collaboration with the sphingotec GmbH.
The recently marketed Adrenomedullin assay (sphingotest® bio-ADM®) allows the identification of patients suffering from loss of vascular integrity and will enable physicians to specifically treat these people by using Adrecizumab.
Adrecizumab is currently under clinical evaluation in the AdrenOSS-2 trail, a biomarker-guided, double-blind, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial in 300 septic shock patients. Excellent safety and tolerability were demonstrated in two Phase I trials.
Results of Phase I trials evaluating Adrecizumab safety and tolerability
Vascular integrity – fundamental for human health
Regulation of vascular integrity is a fundamental process for human physiology and pathology. The vascular endothelium is the essential organ for the function of blood vessels in the human body. It is a cell monolayer that forms an essential and selective barrier between the blood vessels and the tissue compartment. The vascular endothelium actively maintains more than 60,000 miles of blood vessels.
Conditions that are most threatening to life, such as sepsis and acute heart failure, are driven by severe impairment of the vascular endothelial barrier presenting in porous, leaky blood vessels and resulting in tissue congestion and edema. Ultimately, the rapid fall in blood pressure and diminished oxygen supply to organs leads to multiple organ failure and death.
Adrenomedullin (ADM) – key regulator of vascular integrity
Since its discovery in 1993, the vasoprotective hormone Adrenomedullin has attracted a great deal of interest as a multifunctional regulator of the vascular system.
Adrenomedullin is a free-circulating peptide that is mainly expressed and secreted by vascular endothelial cells and is known for its vasodilatory activity in the interstitium resulting in decreased blood pressure (Shock, 2018). In the circulation, Adrenomedullin directly tightens the gaps between endothelial cells, subsequently preventing vascular leakage.
Adrenomedullin (bio-ADM®) was validated as therapeutic target and biomarker in an analysis of over 16,500 well-defined patients’ samples in collaboration with the diagnostics company sphingotec GmbH. Rising bio-ADM® values in patients’ blood samples clearly indicate a worsening of vascular integrity independent from inflammation or any other comorbidity, allowing the inclusion of all critical ill patients.
Sepsis & Septic Shock
Sepsis is a life-threatening condition that results in organ dysfunction caused by a dysregulated host response to infection. It is driven by severe loss of vascular integrity, presenting in impaired and leaky blood vessels and resulting in congestion and edema. Septic shock is the most severe form of sepsis characterized by a rapid fall in blood pressure requiring vasopressor treatment, and diminished oxygen supply to organs leading to profound circulatory, cellular and metabolic abnormalities and finally multiple organ failure.
Today, sepsis and septic shock are major healthcare problems, affecting millions of people around the world every year and killing as many as one in four. In the United States, sepsis causes or contributes to between one-third and one-half of all deaths occurring in hospitals. Currently, the incidence rate is increasing and the mortality rate still remains high at about 30%. Once the patient develops septic shock, due to loss of vascular integrity, the mortality rate rises to 50-80%. The current standard of care in sepsis patients is limited to early treatment with antibiotics and administration of fluids and vasopressors (hemodynamic support).
Adrenomed’s Adrecizumab successfully passes interim analysis in early septic shock study AdrenOSS-II
AdrenOSS-II trial continues as planned after positive interim efficacy analysis triggered by the treatment of 50% of randomized patients Proof-of-concept trial design testing Adrecizumab in early septic shock presented at International Symposium on Intensive Care and Emergency Medicine (ISICEM) Adrecizumab
Hennigsdorf (Germany), March 12, 2019 – Adrenomed AG, the vascular integrity company, announced today its participation in three upcoming conferences in Europe. Adrenomed representatives will be available for one-on-one meetings at these events. 12th Berlin Conference on Life Sciences,
Ongoing proof-of-concept trial AdrenOSS-II testing Adrecizumab in early septic shock Adrecizumab is a first-in-class antibody targeting Adrenomedullin, to rescue vascular function Vascular integrity, regulated by Adrenomedullin, is key to preventing vascular leakage and septic shock Hennigsdorf (Germany) February, 7, 2019
Published in the January 2019 edition of MedNous, a publication of Evernow Publishing Ltd.
Article in ENDPOINTS: Wellington, HBM lead €24M round as Adrenomed preps septic shock treatment for human testing
by Amber Tong. Go to the article
by Jo Shorthouse.
12th Berlin Conference on Life Science Novel Antimicrobials ans AMR Diagnostic 2019 14-15 March | Berlin, Germany Link to the Conference
ISICEM, 39th International Symposium on Intensive Care and Emergency Medicine, March 19-22, 2019 | Brussels, Belgium Talk: March 21, 2019, at 8:30 – 8:45 AM CET, Salle M (Bozar) “The adrenomedullin antibody adrecizumab” during the session “New therapies for Sepsis”,
BIO-Europe Spring Messe Wien Exhibition and Congress Center, 25–27 March 2019 | Vienna, Austria Company Presentation on the 27th of March, 9:30 AM CET, Room Schubert 5 (on Level 1). Category: Cardiovascular. Speaker: Dr. Frauke Hein, Chief Business Officer Link