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Sobi's Latest Research Collaboration on Gamifant® for Sepsis

On March 19, 2025, Sobi® (STO: SOBI) announced an insightful research collaboration aimed at advancing the use of Gamifant® (emapalumab) in treating interferon-gamma-driven sepsis (IDS). This promising phase 2a clinical trial, named EMBRACE, will be discussed at the prestigious International Symposium on Intensive Care and Emergency Medicine (ISICEM) Congress, featuring insights from Prof. Evangelos Giamarellos-Bourboulis from the Hellenic Institute for the Study of Sepsis.

Understanding Interferon-Gamma-Driven Sepsis

Interferon-gamma (IFNγ)-driven sepsis is a relatively new endotype found in about 20% of sepsis patients. The condition is defined by elevated levels of the chemokine CXCL9 and increased detection of IFNγ, both linked to poor clinical outcomes. This understanding underscores the need for specific treatment strategies, as traditional protocols may fall short for patients uniquely affected by this endotype.

With a staggering mortality rate of 40-43% over a 28-day period, the need for innovative treatments in this area is critical. Sobi's EMBRACE study hopes to target this urgent medical requirement directly by using Gamifant® as an anti-IFNγ monoclonal antibody capable of neutralizing the effects of excessive interferon gamma in these patients.

Key Features of the EMBRACE Study

The EMBRACE study (NCT06694701) involves a carefully structured trial conducted across 24 sites in Greece. It is designed as a double-blind, randomized controlled trial that will include 75 participants. This group will consist of individuals with the IDS endotype who do not exhibit sepsis-induced immunoparalysis, which is often characterized by a low expression of human leukocyte antigen DR (HLA-DR) on monocytes.

The trial comprises three arms:

• - Two groups receiving Gamifant® at different dosages alongside standard care,
• - One placebo group with standard care.

The primary goal is a significant reduction in the Sequential Organ Failure Assessment (SOFA) score from baseline to the end of treatment over 28 days, with secondary outcomes focusing on 28-day mortality, safety, and various inflammatory biomarkers.

Commitment to Advancing Medical Science

In a recent statement, Dr. Lydia Abad-Franch, Sobi's Chief Medical Officer, emphasized the company's dedication to exploring the potential of Gamifant® in treating conditions with substantial unmet needs, particularly where excessive IFNγ production is a significant factor driving severe inflammation.

The EMBRACE study is vital as it adopts a precision immunotherapy approach, aiming to expand therapeutic options for patients who currently have few effective alternatives. Prof. Giamarellos-Bourboulis will outline this detailed methodology at the ISICEM, shedding light on both the design and anticipated implications of the EMBRACE trial.

Conclusion

Sobi's initiative represents a crucial step toward understanding and treating a unique and severe subset of sepsis patients. By harnessing Gamifant® for these individuals, the EMBRACE trial reflects a broader commitment to innovating treatment strategies where they are most needed, potentially paving the way for improved outcomes in a condition that remains a leading global health crisis. As the first trial sites commence patient screening, the outcomes from EMBRACE could have far-reaching implications not only for patients suffering from IDS but for the broader medical community addressing sepsis as a whole.

For more information about Sobi and ongoing projects, visit their official site or follow them on LinkedIn.