NEWS





ABOUT US



COMPANY PROFILE

Adrenomed AG is a privately-financed, clinical-stage biopharmaceutical company with a clear mission: developing precision medicine to rescue vascular integrity and saving 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 current lead indications are sepsis and septic shock.

We translate the concept of precision medicine into acute care. Our biomarker-guided approach enables us to identify the patients with loss of vascular integrity as an underlying pathophysiological disease mechanism and to treat patients that will most likely benefit from Adrecizumab therapy. 

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.

HISTORY

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.

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.

MANAGEMENT

Dr. Andreas Bergmann

Chief Scientific Officer (CSO)

Dr. Andreas Bergmann, co-founder and Chief Scientific Officer (CSO) of Adrenomed and CEO of sphingotec GmbH and 4TEEN4 Pharmaceuticals 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 with over 30 years of experience as clinical operations, medical affairs and market access 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 Chief Business Officer of Adrenomed management has over 20 years experience in the biotech and diagnostic industry. 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.

Supervisory Board

Dr. Erich Schlick (Chairman)

General Partner at Wellington

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

Dr. Bernd Wegener

Co-founder of Adrenomed with over 35 years of management experience in the diagnostic and pharmaceutical industry

INVESTORS



RESEARCH & DEVELOPMENT



Adrenomed is dedicated to saving 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 guided approach utilizing the target Adrenomedullin for patient selection, Adrenomed is developing a unique and holistic approach to rescue vascular integrity in life-threatening conditions such as sepsis and septic shock.

ADRECIZUMAB

The Company’s lead product candidate is Adrecizumab (HAM8101; INN: enibarcimab), 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

Adrecizumab mode of action

Adrecizumab targets Adrenomedullin (ADM), a vasoprotective peptide hormone. As a small peptide, ADM can easily leave the bloodstream by crossing the endothelial barrier and entering the extravascular space, where it affects vascular smooth muscle cells (VSMC) and regulates vascular tone by promoting vasodilation—an unwelcome effect in the context of sepsis as it contributes to increased hypotension and organ damage. ADM that remains in the bloodstream, however, has a different effect, one that helps mitigate sepsis: promoting stability of the endothelial barrier by restoring the cell junctions between endothelial cells that ordinarily regulate molecule transport and leakage. In health, levels of ADM in the bloodstream and extravascular space are in equilibrium so that endothelial barrier integrity is maintained and blood pressure remains normal.

Loss of vascular integrity in septic shock

Adrecizumab therapeutic approach

In sepsis, more ADM is produced to counteract loss of endothelial barrier function, but as the endothelial barrier becomes more permeable as a result of systemic immune dysregulation, more ADM enters the extravascular space in a dangerous cycle that can contribute to shock and organ failure.

Administration of the monoclonal antibody Adrecizumab results in an elevation of ADM concentration within the circulation. The ADM-Adrecizumab complex is functional, thus ADM can still act on the endothelium. Consequently, Adrecizumab treatment immediately and precisely promotes ADM’s protective effects on the endothelial barrier.

For further information on the mode of action of Adrecizumab see title story and editorial in the peer-reviewed journal SHOCK (Shock, 2018).

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 improves 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.

clinical development

The lead candidate Adrecizumab is ready for a pivotal trial. In the AdrenOSS-2 (proof-of-concept phase II trial in septic shock) Adrecizumab demonstrated a favorable safety profile, was well tolerated and showed improved organ function and survival compared to placebo.

The monoclonal antibody Adrecizumab, presented a favorable safety profile in septic shock patients. Thereby meeting the primary trial objective. An improvement of organ function and a subsequent reduction of mortality has been observed.

A pre-specified biomarker analysis illustrated that treatment with Adrecizumab after ICU admission resulted in a rapid and sustained improvement of systemic organ function (SOFA score). Subsequently, the relative mortality was reduced by more than 30% after day 28. The positive effect on survival persisted over 90 days.
For further information please see the following article.

The biomarker-guided, randomized, double-blind, placebo-controlled proof-of-concept trial AdrenOSS-2 investigated the safety, tolerability and efficacy of Adrecizumab in 301 patients with early septic shock and elevated blood levels of Adrenomedullin. The multi-centre trial was carried out in Belgium, France, Germany and the Netherlands. In addition to standard of care, patients received Adrecizumab or placebo. The Phase II trial design was published in BMJ Open (BMJ Open, 2019).

Results of Phase I trials evaluating Adrecizumab safety and tolerability

The randomized, double-blind, placebo-controlled Phase Ia and Ib studies included a total of forty-eight healthy volunteers to evaluate escalating doses of Adrecizumab.

Adrecizumab demonstrated an excellent safety profile in both studies. Additionally, the Phase Ib study in systemic inflammation indicated dose-dependent beneficial effects of Adrecizumab on vascular integrity without affecting inflammatory parameters. Results of the Phase Ia/b trials were published in the British Journal of Clinical Pharmacology (Br J Clin Pharmacol, 2018).

Publications



VASCULAR INTEGRITY



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 100,000 kilometers of blood vessels.

Conditions that are most threatening to life, such as sepsis, septic shock, 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.
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

Every year, millions of people around the world are affected by sepsis. In the US, sepsis contributes to between one third and half of deaths of hospitalized people, making it the number one cause of death in hospitals (JAMA, 2014). The annual cost of treating sepsis patients amounts to US$24 billion (Crit Care Med, 2018) in the US alone.

Sepsis has been defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection (JAMA, 2016). This means that the body’s systemic immune reaction to an infecting pathogen gets out of control and starts affecting tissues and organs. Alongside these inflammatory responses, different regulatory systems such as cardio-vascular, metabolic and coagulation are affected.

A central driver of the pathogenesis of sepsis is the increasing loss of endothelial barrier function. In other words: The loss of vascular integrity. This leads to an uncontrolled leakage of fluid, proteins and cells into the surrounding tissue.

Patients suffer from a rapid drop in blood pressure (hypotension) and strong abnormalities in circulatory, cellular, and metabolic function. The reduced blood pressure, which further limits oxygen supply to organs (hypoperfusion), contributes to the development of multi-organ failure and death.

The current standard of care for septic shock patients is limited to anti-infectives, administration of vasopressors, fluids and supportive care.

With a biomarker-guided approach utilizing Adrenomedullin as a diagnostic marker and therapeutic target, Adrecizumab addresses the loss of vascular integrity to reduce vascular leakage, restore hemodynamic stability and consequently improve organ function and reduce mortality.



NEWS & EVENTS



Press Releases

#DeutschlandErkenntSepsis

Adrenomed supports the #DeutschlandErkenntSepsis campaign initiated by Aktionsbündnis Patientensicherheit and supported by Sepsis Stiftung, Sepsisdialog and Deutsche Sepsis-Hilfe. The campaign’s goal is to raises awareness of sepsis and to improve recognition, diagnosis, and treatment of sepsis. In Germany only, every

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media coverage

Events

Weimar Sepsis Update, September 8 – 10, 2021

Weimar Sepsis Update, Sep 8-10, 2021 Adrenomed will co-host the symposium “Precision Medicine in Septic Organ Failure: Biomarker-guided Diagnosis and Therapy” on September 9th, 12:00-13:30 CEST Chair: Prof. Dr. med. Markus Weigand Link to the Conference

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ISICEM, August 31 – September 3, 2021

ISICEM, Aug 31 – Sep 3, 2021 Prof. Pierre-François Laterre, MD, Head of the medical-surgical intensive care unit at Saint Luc University Hospital, Brussels, will talk about Adrecizumab in the session “The Future of Sepsis Therapies”, room Tent, September 2,

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CAREER



Adrenomed – a clinical-stage biopharmaceutical company, located in the Berlin area.

We are a multi-disciplinary, international team committed to pioneering the development of precision medicine for critically ill patients with limited treatment options.

We are always looking for talented, dedicated professionals to join our team. Check our current job listings to find out more.  

Applications are always welcome, even if we do not have any listed openings. Please submit a resume and cover letter to career@adrenomed.com.

Current Job Listings