AdrenoMed advances personalized septic shock therapy as new sepsis guidelines and U.S. policy highlight urgent unmet need

AdrenoMed AG is highlighting the urgent need for innovative, personalized therapies for septic shock as sepsis comes under renewed focus through the 2026 Surviving Sepsis Campaign Guidelines and the U.S. SEPSIS Act.

In May 2026, following alignment with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), AdrenoMed announced preparations to advance its investigational therapy enibarcimab into a biomarker-guided Phase III clinical trial, reinforcing why targeted, evidence-based approaches are essential to close persistent therapeutic gaps and improve survival in septic shock.

Global burden of sepsis and septic shock

Sepsis remains a major global public health challenge, with an estimated 48.9 million cases and 11 million sepsis-related deaths each year, accounting for nearly 20% of all deaths worldwide. Even in regions such as Europe and North America, where patients have access to advanced intensive care, septic shock, the most severe form of sepsis, is associated with a fatality rate of 30–40%.

The 2026 Surviving Sepsis Campaign Guidelines and the U.S. SEPSIS Act underscore the scale of this burden and the need to improve outcomes through evidence-based care, earlier recognition and better data. These developments also reinforce the importance of continued therapeutic innovation to address the high mortality and limited treatment options in septic shock.

Enibarcimab: A biomarker-guided investigational therapy for septic shock

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

By focusing on biomarker-guided patient selection, AdrenoMed aims to deliver a more personalized approach to septic shock therapy, targeting those at highest risk and potentially improving clinical outcomes compared with standard, non-targeted treatment strategies.

Regulatory alignment in the U.S. and Europe

AdrenoMed has received positive feedback from both the FDA and EMA on its proposed late-stage development plan for enibarcimab. Regulatory authorities are supporting a single pivotal Phase III registration study designed to support marketing applications in both the U.S. and the EU.

The agreed study design includes 28-day all-cause mortality as the primary endpoint, reflecting the critical importance of survival outcomes in septic shock. This regulatory alignment provides a clear pathway for the late-stage clinical development of enibarcimab, contingent on securing the necessary funding to initiate and complete the pivotal trial.

Call for funding to advance therapeutic innovation in sepsis

AdrenoMed emphasizes that, while policy initiatives such as the U.S. SEPSIS Act signal that sepsis is being recognized as a major public health priority, this recognition must be matched by adequate financial support for therapeutic innovation.

“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.”

Personalized, evidence-based approaches to improve septic shock outcomes

The combination of updated clinical guidelines, new U.S. policy measures and ongoing therapeutic development highlights a critical shift toward personalized, evidence-based care in sepsis and septic shock. By integrating biomarker-guided patient selection with a therapy designed to stabilize vascular integrity, AdrenoMed aims to address a key pathophysiological mechanism in septic shock and improve survival in patients who are most likely to benefit.

As healthcare systems work to implement the 2026 Surviving Sepsis Campaign Guidelines and respond to the U.S. SEPSIS Act, closing the therapeutic gap in septic shock remains a priority. Advancing late-stage clinical programs such as enibarcimab will require sustained investment and collaboration across industry, regulators and policymakers to translate scientific innovation into improved patient outcomes.

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