AdrenoMed Highlights Need for Personalized Therapies in Septic Shock Amid New Sepsis Guidelines and U.S. Policy Initiative

Press Release

AdrenoMed Highlights Need for Personalized Therapies in Septic Shock Amid New Sepsis Guidelines and U.S. Policy Initiative

• 2026 Surviving Sepsis Campaign Guidelines and U.S. SEPSIS Act reinforce the need to close persistent therapeutic gaps in septic shock and improve survival through personalized, evidence-based approaches
   
• Following alignment with regulatory authorities in the U.S. and Europe, AdrenoMed is preparing its investigational therapy enibarcimab for a pivotal, biomarker-guided Phase III clinical trial while emphasizing the need for funding

Hennigsdorf / Berlin (Germany), May 19, 2026 – AdrenoMed AG, the vascular integrity company, today emphasized the urgent need for innovative, personalized therapies for septic shock as sepsis gains renewed attention through the 2026 Surviving Sepsis Campaign Guidelines and the U.S. SEPSIS Act.^{1, 2} Together, these developments underscore the scale of the sepsis challenge and the need to improve outcomes through evidence-based care, earlier recognition and better data, while also reinforcing the importance of continued therapeutic innovation.

Sepsis is a major public health challenge, with an estimated 48.9 million cases and 11 million sepsis-related deaths annually, accounting for nearly 20% of global deaths. Even in Europe and North America where patients receive cutting-edge advanced intensive care, septic shock, the most severe form of sepsis, is associated with a fatality rate of 30-40%.³

In response, AdrenoMed is preparing for the pivotal clinical trial of enibarcimab, a non-blocking monoclonal antibody designed to stabilize vascular integrity and improve survival in septic shock patients. This investigational treatment builds on the Phase II AdrenOSS-2 trial and uses two biomarkers (bio-ADM and DPP3) to identify septic shock patients most likely to benefit from enibarcimab.

AdrenoMed has received positive feedback from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), supporting its proposed late-stage development plan, which includes a single pivotal Phase III registration study to support marketing applications in both the U.S. and EU.

“We are encouraged by the positive feedback from both FDA and EMA and already aligned on a study design with all relevant components. They are supporting a single registration study approach and 28-day all-cause mortality as the primary endpoint. AdrenoMed remains committed to advancing enibarcimab into a pivotal clinical Phase III trial, upon securing adequate funding,” said Dr. Richard Jones, Chief Executive Officer of AdrenoMed AG. “Policy initiatives such as the U.S. SEPSIS Act are an important signal that sepsis must be addressed as a major public health priority. To truly improve outcomes in septic shock, this focus should be adequately matched by financial support for therapeutic innovation such as targeted, biomarker-guided approaches that have the potential to reach the patients at highest risk.”

About enibarcimab

Enibarcimab (formerly known as Adrecizumab) is a humanized, non-neutralizing monoclonal antibody targeting adrenomedullin (ADM), a key regulator of vascular integrity. By binding to ADM, enibarcimab increases plasma levels of bioactive ADM, enhancing its beneficial effects on endothelial function and counteracting sepsis-induced vascular leakage. Designed as a first-in-class therapy, enibarcimab aims to restore vascular integrity in patients with septic shock, addressing one of the critical pathophysiological mechanisms contributing to organ failure and mortality. Enibarcimab is being developed with a precision medicine approach, guided by biomarker-based patient selection strategies.

About AdrenOSS-2

AdrenOSS-2 was a Phase II, double-blind, placebo-controlled, randomized, multicenter clinical trial (n=301) designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of enibarcimab in patients with early septic shock. The study incorporated a biomarker-guided enrichment strategy, selecting patients based on elevated concentrations of bioactive adrenomedullin (bio-ADM), a marker of endothelial dysfunction. A prespecified subgroup analysis further stratified patients by introducing dipeptidyl peptidase 3 (DPP3) as a second biomarker to exclude individuals unlikely to respond to enibarcimab treatment. DPP3 is a cytosolic enzyme involved in the degradation of various cardiovascular and endorphin mediators, with elevated levels indicating a high risk of organ dysfunction and mortality. This pathological pathway is mechanistically distinct from the loss of vascular integrity — the primary driver of mortality in septic shock — which is reflected by elevated plasma levels of bio-ADM (>70 pg/mL).

About AdrenoMed

AdrenoMed AG is a German privately financed, clinical-stage biopharmaceutical company. AdrenoMed’s mission is to rescue vascular integrity in order to save the lives of critically ill patients with limited treatment options. Founded in 2009 by a management team with decades of in-depth experience in sepsis and deep knowledge in diagnostics and drug development, the company’s lead product candidate enibarcimab (formerly Adrecizumab) is a first-in-class non-blocking monoclonal antibody. Enibarcimab targets the vasoprotective peptide Adrenomedullin, an essential regulator of vascular integrity. Enibarcimab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock. For further information, please visit www.adrenomed.com and follow us on LinkedIn.

Contact
AdrenoMed AG
phone: +49 (0)3302 207780
info@adrenomed.com

Media Inquiries
MC Services AG
Eva Bauer / Julia von Hummel
phone: +49 (0)89 2102280
adrenomed@mc-services.eu

^[1]  Prescott, H.C., Antonelli, M., Alhazzani, W. et al. Surviving Sepsis Campaign: international guidelines for management of sepsis and septic shock 2026. Intensive Care Med (2026). https://doi.org/10.1007/s00134-026-08361-1

^[2]  U.S. Senate draft bill, “Securing Enhanced Programs, Systems, and Initiatives for Sepsis Act” / “SEPSIS Act”

^[3]  Rudd KE, Johnson SC, Agesa KM, et al. Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global Burden of Disease Study. Lancet. 2020;395:200-211. https://doi.org/10.1016/S0140-6736(19)32989-7