Sobi Collaborates on Gamifant® Research to Fight Sepsis at ISICEM 2025

Sobi Announces Research Collaboration on Gamifant® for Sepsis

Sobi® (STO: SOBI) has recently unveiled a promising research collaboration aimed at advancing treatments for sepsis, specifically focusing on Gamifant® (emapalumab), in a new Phase 2a clinical trial. This exciting initiative will be highlighted at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) Congress, presented by Professor Evangelos Giamarellos-Bourboulis from the Hellenic Institute for the Study of Sepsis, showcasing Sobi's commitment to innovative medical solutions for complex diseases.

Key Insights into the Trial

This trial is particularly focused on a newly identified endotype of sepsis known as interferon-gamma-driven sepsis (IDS). Research indicates that approximately 20% of sepsis patients fall into this category. IDS is characterized by high levels of interferon-gamma (IFNγ) and the chemokine CXCL9, both associated with poor clinical outcomes and increased 28-day mortality rates, which reach alarming figures between 40% and 43%.

The EMBRACE Phase 2a study aims to explore the efficacy of Gamifant® in treating this specific group of sepsis patients. Importantly, patients suffering from immunoparalysis, indicated by low human leukocyte antigen DR (HLA-DR) expression on monocytes, will not be included in this particular study. Future trials may consider this subgroup depending on the outcomes of the current research.

EMBRACE Study Details

Initiated in March 2025, the EMBRACE trial (NCT06694701) will involve 24 sites across Greece. The trial’s design includes three arms, with an enrollment of 75 participants. Two groups will receive varying doses of Gamifant® alongside standard care, while a control group will receive a placebo with standard treatment.

The primary endpoint of this trial is achieving a decrease of 1.4 points or more in the Sequential Organ Failure Assessment (SOFA) score by the end of treatment at 28 days. Secondary endpoints will encompass 28-day mortality, safety assessments, pharmacokinetics, and changes in inflammatory biomarkers.

Gamifant® Profile

Gamifant® (emapalumab) is an anti-IFNγ monoclonal antibody designed to neutralize IFNγ levels. In the U.S., it is approved for treating both adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH), especially for those who do not respond to conventional therapies. This approval was grounded on solid data collected from Phase 2/3 clinical trials, reinforcing the efficacy and safety of Gamifant®.

Sobi’s Commitment to Innovative Therapies

Sobi is a biopharmaceutical company dedicated to improving the lives of patients with rare and serious diseases. By prioritizing the development of new therapies, Sobi aims to address significant unmet medical needs, particularly in areas where excessive production of interferon-gamma exacerbates conditions.

As the medical community eagerly anticipates the results from the EMBRACE trial, there is hope that Gamifant® will pave the way for enhanced treatment strategies for sepsis patients, especially for those suffering from this newly identified endotype. Sobi's advancements in the sector reaffirms their position as a leader in the biopharmaceutical industry, contributing solutions to critically ill patients worldwide.

For further insights, Prof. Giamarellos-Bourboulis will discuss the trial’s design and implications at the ISICEM Congress, potentially shedding light on a path forward in sepsis treatment and care.