Sobi announces a Phase 2a EMBRACE trial evaluating Gamifant (emapalumab) for interferon-gamma–driven sepsis, a newly identified high-mortality sepsis endotype.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Sobi has announced a research collaboration to investigate Gamifant (emapalumab) as a potential treatment for interferon-gamma–driven sepsis (IDS), a newly identified subgroup of sepsis characterized by excessive immune activation.
The Phase 2a EMBRACE trial design will be presented at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) by Prof. Evangelos Giamarellos-Bourboulis from the Hellenic Institute for the Study of Sepsis. The initiative reflects Sobi’s ongoing effort to explore targeted therapies for severe inflammatory conditions with high mortality.
IDS is a recently described sepsis endotype that accounts for roughly 20% of sepsis patients. It is defined by detectable interferon-gamma (IFNγ) and elevated levels of the inflammatory chemokine CXCL9. Patients with this endotype often experience poor clinical outcomes, with reported 28-day mortality rates of around 40–43%. Researchers believe that identifying such immune-driven subtypes of sepsis could enable more precise therapeutic strategies.
The EMBRACE Phase 2a study (NCT06694701), approved in March 2025, is a double-blind, randomized controlled trial planned across 24 sites in Greece. The study aims to determine whether Gamifant (emapalumab), an anti-IFNγ monoclonal antibody, can improve outcomes in patients with IDS who do not exhibit sepsis-induced immunoparalysis. Patient screening has already begun at initiated study sites.
The trial will enroll 75 patients and includes three treatment arms: two groups receiving Gamifant at low or high doses plus standard-of-care therapy, and one group receiving placebo alongside standard care. The primary endpoint is a reduction of at least 1.4 points in the Sequential Organ Failure Assessment (SOFA) score from baseline to day 28.
Secondary endpoints include 28-day mortality, safety, pharmacokinetics, and changes in inflammatory biomarkers such as CRP, IL-6, ferritin, IFNγ, and CXCL9.
Patients with IDS who also display low HLA-DR expression on monocytes, a marker of sepsis-induced immunoparalysis, will be excluded from the trial. Researchers plan to evaluate the inclusion of this subgroup in future studies depending on the outcomes of EMBRACE.
Prof. Evangelos Giamarellos-Bourboulis, principal investigator and sponsor of the study, said the trial will adopt a precision immunotherapy approach aimed at a sepsis subgroup with limited treatment options.
Lydia Abad-Franch, MD, Chief Medical Officer and Head of Research & Development and Medical Affairs at Sobi, noted that the company is exploring Gamifant in conditions where excess interferon-gamma plays a key role in driving hyperinflammation, reflecting the company’s focus on diseases with high unmet medical need.
Gamifant (emapalumab) is a monoclonal antibody that binds to and neutralizes interferon-gamma, a cytokine involved in inflammatory immune responses. In the United States, the therapy is approved for the treatment of primary haemophagocytic lymphohistiocytosis (HLH) in adults and pediatric patients with refractory, recurrent, or progressive disease or intolerance to conventional therapy. The approval was supported by data from Phase 2/3 clinical studies.
If successful, the EMBRACE trial could provide early evidence that targeting interferon-gamma–mediated inflammation may offer a new precision treatment strategy for a defined subgroup of patients with sepsis, a condition that remains one of the leading causes of mortality worldwide.
Reference
Sobi announces a new research collaboration on the development of Gamifant® (emapalumab) in sepsis, which is to be presented at the ISICEM congress, 18 March 2026, Sobi announces a new research collaboration on the development of Gamifant® (emapalumab) in sepsis, which is to be presented at the ISICEM congress | Sobi
Emapalumab Treatment for Anticipated Clinical Benefit in Sepsis Driven by the Interferon-Gamma Endotype (The EMBRACE Trial) (EMBRACE), ClinicalTrials.gov ID NCT06694701, https://clinicaltrials.gov/study/NCT06694701
About the Writer
Nikita Jha BPharm is a pharmacy graduate with expertise in clinical research, pharmacovigilance, and medical writing. In her words, she is passionate about translating complex scientific data into clear, accurate healthcare communications that advance drug safety and patient care.