3CT 2024 – Critical Care Clinical Trialists Workshop
3CT 2024 – Critical Care Clinical Trialists Workshop13-15 June| Wahsington DC, USA Vist the 3CT website.
AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock
Hennigsdorf/Berlin (Germany), April 10, 2024 –AdrenoMed AG, the vascular integrity company, today announced that the US Food and Drug Administration (FDA) has granted Fast Track
Article in InVivo: End Game: Adrenomed Targets Global Reach For Sepsis Candidate
The article was published by David Wild, In Vivo, Citeline Commercial.
ABOUT US
Company Profile
AdrenoMed AG is a German privately financed, clinical-stage biopharmaceutical company. Since 2009, AdrenoMed does have a clear mission: saving the lives of critically ill patients.
Our Company’s lead product candidate is Enibarcimab (INN, former name: Adrecizumab), a clinical-stage, first-in-class antibody. Enibarcimab 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 indication is septic shock.
At AdrenoMed 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 and to treat patients that will most likely benefit from Enibarcimab therapy.
Executive Management
Dr. Richard Jones
Chief Executive Officer (CEO)
Dr. Richard Jones, Chief Executive Officer (CEO) of AdrenoMed, provides over 25 years of experience in the pharmaceutical and biotech industry with a strong record of achievements in business, clinical development and commercialization. Before joining AdrenoMed in March 2022, Dr. Jones served as CEO of Fusion Antibodies Plc. Previously, he was CEO for several UK and European private companies as well as SVP, Head of Europe for a US based public company. Also, he gained expertise at Novartis and GSK as VP, Medicines Commercialization Leader, Global Haematology at both companies.
David Germonpré, MSc/Executive MBA
Chief Financial Officer (CFO)
David Germonpré, Chief Financial Officer (CFO), has over 15 years of experience as finance leader and strategist. Before joining AdrenoMed in July 2022, Mr. Germonpré was Partner at MTIP, a Switzerland-based health-tech growth capital investor. Previously, for the Gemma Frisius Fund he invested in spinouts from Belgium’s KU Leuven. Between 2009 and 2013 David advised the Government of Flanders on its VC and PE programs. Prior to that he worked as investment banker at Dexia Bank, executing M&As and IPOs of big corporates.
Dr. Stephan Witte
Chief Medical Officer (CMO)
Dr. Stephan Witte is a drug development professional with over 20 years’ experience in clinical drug development and registration and a strong disease expertise in sepsis and septic shock. Before joining AdrenoMed, Stephan Witte, Ph.D., was Vice President Clinical Science & Operations at Atriva Therapeutics, a clinical-stage biotech company focusing on antiviral therapeutics. Prior to that, he was Vice President Clinical Trials at Breath Therapeutics and Head of Clinical Development and Regulatory Affairs at Inotrem, a biotech company specializing in inflammatory syndromes including septic shock.
Supervisory Board
Dr. Erich Schlick (Chairman)
Independent management consultant with over 40 years of experience in the pharma industry
Dr. Priyanka Belawat
Investment Advisor at HBM Partners
Dr. Renke Lührs
Partner at Buse Heberer Fromm
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. Christoph Springer
Independent Advisor
Dr. Rainer Strohmenger
Managing Partner at Wellington Partners
Investors
RESEARCH & DEVELOPMENT
AdrenoMed has developed a unique and novel precision medicine approach to restore and protect the integrity of the vascular endothelium in life-threatening conditions. Our lead compound Enibarcimab is currently developed for the treatment of sepsis and septic shock.
Our biomarker-guided treatment solution enables us to identify and treat the right patients. Key is the reduction of patient heterogeneity through the selection of addressable patients that are at high risk due to the underlying pathophysiology (loss of vascular integrity) and the exclusion of patients with competing disease mechanisms.
Enibarcimab
The lead drug candidate Enibarcimab (HAM8101; former name: Adrecizumab) is a clinical-stage, first-in-class drug targeting the restoration of vascular integrity, influencing the pathophysiology in critically ill patients. The strong mechanistic rationale for Enibarcimab is supported by the elegance of its mode of action, an antibody that – on binding to its target Adrenomedullin– preserves the functionality as the regulator of vascular integrity.
Enibarcimab mode of action
Enibarcimab’s mechanism of action is based on generation of elevated levels of biologically active Adrenomedullin (ADM) in the circulation, where it exerts its beneficial effect on the endothelial barrier. This leads to the alleviation of sepsis-induced circulatory dysfunction, improvement of organ function and ultimately reduced mortality.
Adrenomedullin is a key regulator of endothelial barrier function and tone. The peptide can easily leave and enter the bloodstream by crossing the endothelial barrier. In healthy people, levels of ADM in the bloodstream and extravascular space are in equilibrium ensuring that endothelial barrier integrity is maintained, and blood pressure remains normal.
Administration of a single dose of Enibarcimab is sufficient to bind and trap Adrenomedullin (ADM), in the vasculature, protecting it from proteolytic decay and simultaneously preserving the biological activity of ADM.
Loss of vascular integrity in septic shock
Enibarcimab therapeutic approach
In sepsis, more ADM is produced to counteract the 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 acting on vascular smooth muscle cells (VSMC) and may induce relaxation that can contribute to shock and organ failure.
Administration of Enibarcimab results in a rapid and sustained elevation of ADM concentration within the circulation. The large ADM-Enibarcimab complex is functional, stays within the circulation. Thus, ADM continues to act on the endothelium promoting stability of the endothelial barrier by restoring the cell junctions between endothelial cells that ordinarily regulate molecule transport and leakage.
Consequently, Enibarcimab treatment immediately and precisely promotes ADM’s protective effects on the endothelial barrier.
For further information on the mode of action of Enibarcimab see title article and editorial in the peer-reviewed journal SHOCK (Shock, 2018).
clinical development
To date, the clinical development program for Enibarcimab has run two Phase 1 clinical studies (NCT02991508, NCT03083171) in healthy volunteers and a proof-of-concept Phase 2 clinical trial in patients (AdrenOSS-2; NCT03085758).
The biomarker-guided, randomized, double-blind, placebo-controlled proof-of-concept trial AdrenOSS-2 investigated the safety, tolerability and efficacy of Enibarcimab in 301 patients with septic shock and elevated blood levels of Adrenomedullin. The multi-center trial was carried out in Belgium, France, Germany and the Netherlands. In addition to standard of care, patients received Enibarcimab or placebo.
Clinical data from AdrenOSS-2 provided strong clinical proof of concept in the biomarker-defined (active ADM and DPP3 (Dipeptidylpeptidase3)) target population. A prompt improvement of organ dysfunction resulted in a relative reduction of mortality compared to placebo >60% at Day 28. This effect was sustained over 3 months, along with a favorable safety profile.
For further information please see the following information.
Enibarcimab has received FDA Fast Track designation in April 2024 recognizing the urgent medical need in its lead indication septic shock. Adrenomed is preparing a confirmatory trial (BOOST) with Enibarcimab.
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 compartments. 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, acute heart failure and severe viral infections, 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 was validated as therapeutic target and biomarker as reported in several scientific publications. Elevated Adrenomedullin values in a patient’s blood samples clearly indicate a worsening of vascular integrity independent from inflammation or any other comorbidity, reflecting the patient’s 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 (). 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).
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.
The most severe state of sepsis is septic shock. 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, Enibarcimab addresses the loss of vascular integrity to reduce vascular leakage, restore hemodynamic stability and consequently improve organ function and reduce mortality.
Press Releases
AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock
Hennigsdorf/Berlin (Germany), April 10, 2024 –AdrenoMed AG, the vascular integrity company, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate enibarcimab, a first-in-class non-neutralizing monoclonal antibody, for the treatment
Adrenomed to attend San Francisco industry and investor conferences
Hennigsdorf/Berlin (Germany), December 13, 2023 – Adrenomed AG, the vascular integrity company, today announced its participation in upcoming industry and investor conferences. The Adrenomed management team will be available for meetings to present the plans for its global phase 2
Adrenomed presents new findings on its precision medicine treatment for septic shock with enibarcimab during Weimar Sepsis Update
Hennigsdorf/Berlin (Germany), September 8, 2023 – Adrenomed AG, the vascular integrity company, today announced new findings on the biomarker-guided treatment of septic shock with enibarcimab. New data analyses of the phase II clinical trial AdrenOSS-2 validate the precision medicine approach applied
media coverage
Article in InVivo: End Game: Adrenomed Targets Global Reach For Sepsis Candidate
The article was published by David Wild, In Vivo, Citeline Commercial.
Article in MedNous: Adrenomed prepares global study in septic shock
The article was published by Victoria English, MedNous, Evernow Publishing, www.mednous.com
Article on LaBiotech: Watch: Adrenomed tackling huge issue of sepsis
Watch: Adrenomed tackling huge issue of sepsis By Jim Cornall December 19, 2022 Adrenomed AG is a German privately financed, clinical-stage biopharmaceutical company. Its mission is to rescue vascular integrity in order to save the lives of critically ill patients
Events
3CT 2024 – Critical Care Clinical Trialists Workshop
3CT 2024 – Critical Care Clinical Trialists Workshop13-15 June| Wahsington DC, USA Vist the 3CT website.
ISICEM 2024 – International Symposium on Intensive Care & Emergency Medicine
ISICEM 2024 – International Symposium on Intensive Care & Emergency Medicine18-21 March | Brussels, Belgium Meet the AdrenoMed team in Brussels Link to ISICEM
J.P. Morgan Healthcare Conference & Biotech Showcase 2023 – Meet us in San Francisco
J.P. Morgan Healthcare Conference & Biotech Showcase9-12 January | San Francisco, California, USA Meet the AdrenoMed team in San Francisco Link to J.P.Morgan Healthcare Conference Link to Biotech Showcase
CAREER
AdrenoMed is 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.
Applications are always welcome, even if we do not have any listed openings. Please submit a resume and cover letter to career@adrenomed.com.
Please see our applicant and candidate privacy policy.
