Adrenomed to Present New Topline Data from AdrenOSS-2 Trial in Virtual Meeting hosted by Sepsis Comprehensive Center Charité
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
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.
Dr. Jens Schneider-Mergener
Chief Executive Officer (CEO)
Dr. Jens Schneider-Mergener joined Adrenomed in August 2019 and brings more than 25 years of experience in the biotech industry. He was the founder and CEO of Jerini AG specializing in life-threatening and rare disease therapies. He led Jerini through several financing rounds and took the company public in 2005. After the successful launch of Jerini’s lead product FirazyrTM in the EU, he led the acquisition of the company by Shire plc. In 2018 Firazyr generated € 700 Mio. in revenues. Dr. Schneider-Mergener is co-founder of 3B Pharmaceuticals, Berlin and Pharvaris B.V., Leiden and is board member of the Charité Foundation.
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 and joined the Adrenomed Executive Board in July 2019. 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 200 peer-reviewed scientific publications. Since recently, he also acts as Chief Scientific Officer at sphingotec GmbH.
Dr. Bernd Wegener (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. Gerald Moeller
Independent management consultant, co-founder and former CEO of Adrenomed
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, based on analyses of blood samples from well-defined patients, Adrenomedullin was reported as a therapeutic target and biomarker (bio-ADM®) for vascular integrity in several peer-reviewed scientific articles (Crit Care Med, 2020; Crit Care, 2018; Shock, 2018).
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, proof-of-concept phase II trial in septic shock, Adrecizumab demonstrated a favorable safety profile, was well tolerated and demonstrated a trend on survival for Adrecizumab-treated patients compared to placebo.. Favorable safety and tolerability were already demonstrated in previous 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 as reported in several scientific publications. Rising bio-ADM® values in patients’ blood samples clearly indicate a worsening of vascular integrity independent from inflammation or any other comorbidity, reflecting the patients need for a targeted therapy addressing this pathophysiology.
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. 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, sepsis represents an enormous public health burden. The current standard of care in sepsis patients is limited to early treatment with antibiotics and administration of fluids and vasopressors (hemodynamic support).
Adrenomed to Present New Topline Data from AdrenOSS-2 Trial in Virtual Meeting hosted by Sepsis Comprehensive Center Charité
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),
Adrecizumab, given on top of standard of care, was well tolerated and showed a favorable safety profile Adrecizumab demonstrates a positive trend on survival AdrenOSS-2 is a biomarker-guided (sphingotest bio-ADM®) trial in sepsis Mode of Action confirmed: Adrecizumab modulates plasma
Adrenomed completes full enrollment with 300 patients in AdrenOSS-2 trial with Adrecizumab in septic shock
Proof-of-concept Phase II trial AdrenOSS-2 is assessing first-in-class antibody Adrecizumab, designed to restore and maintain vascular integrity AdrenOSS-2 trial design and Adrecizumab mode of action will be presented at the European Society of Intensive Care Medicine (ESICM) annual congress, LIVES
Article in BioCentury Innovation: Adrenomed looks beyond immune modulators for sepsis, aims for shock prevention
October 2019, by Lauren Martz and Inhua Muijrers-Chen, Associate Editors
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