Based on the observed data from this research collaboration with the Hellenic Institute for the Study of Sepsis (HISS), Sobi and HISS will advance emapalumab in IDS and discuss the next clinical development steps with regulatory authorities.

About the EMBRACE study  

The EMBRACE study (NCT06694701) was a Phase 2a, double-blind, randomized controlled trial was conducted at 24 sites in Greece. The study was sponsored by the Hellenic Institute for the Study of Sepsis (HISS) as part of a research collaboration with Sobi. The trial investigated whether Gamifant, an anti-IFNγ antibody, can improve clinical outcomes in patients with the interferon gamma-driven sepsis (IDS) endotype and absence of sepsis-induced immunoparalysis. IDS is characterized by elevated levels of CXCL9 and detectable IFNγ and is associated with poor patient outcomes. By targeting this inflammation pathway, the EMBRACE trial aims to reduce mortality, improve organ function, and accelerate recovery. The trial design includes three arms (a total of 75 patients enrolled), two groups receiving  Gamifant, (low and high doses) alongside standard-of-care treatment, and one group receiving placebo alongside standard-of-care treatment. The primary endpoint is a ≥1.4-point decrease in the Sequential Organ Failure Assessment (SOFA) score from baseline to the end of treatment (28 days). Secondary endpoints include 28-day mortality, safety, pharmacokinetics, and changes in key inflammatory biomarkers such as CRP, IL-6, ferritin, IFNγ, and CXCL9.