Despite the best possible care available today, more than one-third of patients with septic shock do not survive the condition, resulting in 11 million deaths annually. AdrenoMed’s enibarcimab restores the tissue of leaky blood vessels, addressing the most common root cause of septic shock. It has demonstrated promising results in an initial clinical trial, and its potential to meet this significant unmet medical need was recognized by the FDA with a fast-track designation in 2024. Funds raised will be used to launch a global clinical trial, with results expected in 2027. Enibarcimab has the potential to transform the treatment paradigm for sepsis and septic shock.
Premarket/clinical phase
Convertible loan
2027
Personalized medicine
1.000€
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AdrenoMed is a Germany-based biopharmaceutical company with a bold vision: saving the lives of critically ill patients suffering from septic shock and other severe illnesses by restoring and protecting vascular integrity. With a groundbreaking approach rooted in precision medicine, AdrenoMed is addressing a critical unmet need in modern healthcare.
The company has opted for septic shock as the primary indication for its lead candidate, Enibarcimab. This first-in-class antibody has shown clinical proof of concept in a biomarker-guided trial involving over 300 septic shock patients.
The Urgent Global Challenge of Sepsis and Septic Shock
Sepsis and its most severe form septic shock are medical emergencies that claim millions of lives every year, worldwide. Even in first-world countries, these conditions account for up to half of all hospital deaths. Sepsis occurs when the body’s response to infection spirals out of control, causing widespread inflammation and severe damage to the vascular system. As blood vessels loose their integrity, fluids leak into the surrounding tissue, causing swelling. This swelling reduces the oxygen supply to organs, ultimately leading to organ failure and often death.
Current treatments focus on fighting the underlying infection with antimicrobials and managing symptoms by e.g. stabilizing blood pressure and supporting organ function. However, these approaches often fail to address one of the primary underlying causes of the disease: damage to the vascular endothelium. This is where AdrenoMed’s groundbreaking therapy comes into play.
Our innovative therapy targets the vascular endothelium, a crucial barrier that lines the inside of blood vessels. In healthy people, this barrier ensures adequate blood flow, regulates blood pressure and prevents harmful leakage into surrounding tissues. However, in conditions such as sepsis, septic shock and other serious diseases, this barrier can become permeable, leading to a drop in blood pressure and ultimately life-threatening complications such as organ failure.
A First-in-Class Life-Saving Therapy
Enibarcimab is a first-in-class antibody specifically designed to protect and restore the vascular endothelium, directly targeting the root cause of sepsis and septic shock. It works by binding to and enriching active Adrenomedullin (ADM), a naturally occurring peptide essential for maintaining the health of the vascular barrier. By restoring vascular integrity, Enibarcimab helps prevent the damage that leads to the severe complications of septic shock.
Additionally, AdrenoMed has developed a precision medicine approach using biomarkers to identify patients most likely to benefit from Enibarcimab. This strategy focuses on selecting high-risk individuals based on the underlying loss of vascular integrity, the primary driver of septic shock, while excluding those with competing disease mechanisms. By minimizing patient heterogeneity, this approach ensures that only the most appropriate patients receive treatment, improving safety, reducing toxicity, and maximizing treatment efficacy.
Our Clinical Development
Enibarcimab’s clinical development includes two Phase 1 studies in healthy volunteers and the AdrenOSS-2 Phase 2 trial in septic shock. AdrenOSS-2 demonstrated a 67% relative reduction in mortality in patients identified using specific biomarkers (active ADM and DPP3) and a favorable safety profile. Additionally, in 2024, Enibarcimab received FDA Fast Track designation, highlighting its potential to address the urgent need in septic shock treatment. AdrenoMed is now preparing the BOOST confirmatory trial to further validate its efficacy and safety.
“Undoubtedly, AdrenOSS-2 exhibited benefits on survival in septic shock patients, suggesting great potential for endothelial modulation on septic shock outcomes.” – said Prof. Alexandre Mebazaa, Principal Investigator of AdrenOSS-2 and MD, PhD, Chair of Department of Anesthesiology and Critical Care at the Hôpital Lariboisière, Université de Paris (France).
Vision for the Future
AdrenoMed is determined to save lives and improve outcomes for critically ill patients. With Enibarcimab leading the way, the company is advancing toward a future where the devastating toll of sepsis and related conditions is dramatically reduced.
“AdrenoMed is one of painfully few pharmaceutical companies that is taking this type of view in regards to sepsis drug development”, – said Nathan D. Nielsen, MD, MSc, FCCM, Associate Professor from the University of New Mexico School of Medicine, Albuquerque (NM), USA.
As AdrenoMed prepares for the BOOST confirmatory trial, we invite you to join us on this journey. Together, we can make a difference in global health.
AdrenoMed is developing a treatment for sepsis, a complex and lethal disease syndrome that affects the vascular function and is responsible for a high mortality rate. It's solution is based on a first-in-class antibody that restores the integrity of the endothelium (the thin lining of our blood vessels that regulates what goes in and out), which is crucial to prevent septic shock, the most severe form of sepsis. This technology is distinguished by its unique approach, capable of treating the most common cause of sepsis with therapeutic precision.
With a solid track record since its foundation in 2009, AdrenoMed has raised €65 million in equity funding, led by renowned European funds such as Wellington Partners and HBM Healthcare, underlining the backing by large healthcare investors. The company is currently raising a Bridge Financing leading to a full financing for the BOOST confirmatory trial.
The Phase 2a clinical trial has demonstrated proof of concept, with a reduction in 28-days mortality of 24% with standard of care versus 8% when Enibarcimab is added to treatment, validating the potential of the therapy (67% relative mortality reduction). The company is now moving towards a multinational clinical trial in the EU and US, with the aim of obtaining conditional marketing authorisation. With a potential exit approaching, AdrenoMed represents an attractive opportunity.
AdrenoMed faces clinical and competitive risks. Despite promising results from its phase 2 trial, further clinical development carries uncertainties about efficacy in a broader patient population, which could delay marketing authorisation. In addition, although its approach is unique, there is always a risk that competing therapies for the treatment of sepsis may emerge, which could affect its market positioning.
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