Sobi has announced topline results from its Phase IIa EMBRACE study evaluating Gamifant (emapalumab) in patients with interferon-gamma (IFN-γ)-driven sepsis (IDS), highlighting the potential of targeted immunotherapy in a high-risk subset of sepsis patients.

The findings were presented at the International Symposium on Intensive Care and Emergency Medicine by Evangelos J. Giamarellos-Bourboulis, President of the Hellenic Institute for the Study of Sepsis, which sponsored the study in collaboration with Sobi.

Sepsis, a life-threatening condition caused by an abnormal immune response to infection, remains a leading cause of global mortality. The EMBRACE trial explored a precision medicine approach by targeting patients identified through biomarker profiling as having interferon-gamma-driven immune dysregulation.

The Phase IIa, double-blind, randomised controlled trial enrolled 75 patients across 24 sites in Greece. It assessed whether Gamifant, an anti IFN γ monoclonal antibody, could improve clinical outcomes in IDS patients without sepsis-induced immunoparalysis. Participants were divided into three groups, receiving either low or high dose Gamifant alongside standard of care treatment, or placebo.

The primary endpoint of the study was a reduction in the Sequential Organ Failure Assessment (SOFA) score over 28 days. Secondary endpoints included mortality, safety, pharmacokinetics and changes in inflammatory biomarkers such as CRP, IL-6, ferritin, IFN-γ, and CXCL9.

Results indicated that emapalumab was generally well tolerated, with safety findings consistent with its known profile. Infections were the most commonly reported adverse events and no new safety concerns were identified.

The data also reinforce growing evidence that sepsis is a heterogeneous syndrome with distinct biological endotypes requiring tailored treatment approaches. Approximately 20 percent of sepsis patients are believed to fall into the interferon-gamma-driven subtype, which is associated with higher mortality risk.

Sobi noted that it is engaging with regulatory authorities to determine the next steps in the clinical development programme, aiming to generate further evidence for a potential new indication for emapalumab.

Gamifant is currently approved in the United States for treating primary haemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS) in certain patient populations. The therapy works by neutralising interferon-gamma, a key driver of hyperinflammation.

The collaboration with HISS reflects ongoing efforts to advance precision immunotherapy in sepsis, building on a growing body of research and clinical studies conducted by the institute in systemic inflammation.

The latest findings underscore the potential of biomarker-driven strategies to improve outcomes in sepsis, an area where effective targeted treatments remain limited.