Sobi entered a research collaboration involving a new Phase 2a clinical trial for Gamifant (emapalumab) for the potential treatment of interferon-gamma (IFNγ)-driven sepsis (IDS). 

IDS is a new endotype representing approximately 20 percent of sepsis patients and is characterized by detection of IFNγ (above lower limit of detection) and elevated levels of the chemokine CXCL9.

The EMBRACE phase 2a study will investigate the potential of Gamifant (emapalumab) in treating a subgroup of sepsis patients driven by the IDS endotype and absence of sepsis-induced immunoparalysis.

The EMBRACE phase 2a trial (NCT06694701) was approved in March 2025. The first trial sites have been initiated, and patient screening to identify eligible patients with IDS has started.

The trial design is to be presented at ISICEM by Prof. Evangelos Giamarellos-Bourboulis, MD, PhD, FISAC, principal investigator and sponsor of the EMBRACE study, from the Hellenic Institute for the Study of Sepsis (HISS): “The EMBRACE Phase 2a study will adopt a precision immunotherapy approach for the treatment of sepsis driven by the IDS endotype, a patient group currently having limited therapeutic choices.”

“We are looking forward to this research collaboration on the use of Gamifant in the new endotype of interferon gamma-driven sepsis,” said Lydia Abad-Franch, MD, Head of Research & Development and Medical Affairs and Chief Medical Officer at Sobi. “We are committed to advancing science and study Gamifant in indications with a high unmet need and where excessive interferon gamma production plays a key role in driving hyperinflammation.”

Gamifant is an anti-interferon gamma (IFNγ) monoclonal antibody that binds to and neutralizes IFNγ. In the U.S., Gamifant (emapalumab) is indicated for the treatment of adult and pediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Primary HLH is a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated.