Author: admin

Sobi® (STO: SOBI) today announced that topline results from the Phase 2a EMBRACE study evaluating Gamifant® (emapalumab) for interferon-gamma (IFNγ)-driven sepsis (IDS), showed proof-of-concept with observed improvement in organ dysfunction and survival.

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. An update on next steps will be provided in due course and data from the EMBRACE study will be published at an upcoming medical conference.

About sepsis and IFNγ-driven sepsis (IDS)  

Sepsis is a serious condition in response to an infection that can lead to organ failure and is a leading global cause of mortality. A recent large study, published in eBioMedicine in 20241 describes different sepsis endotypes, suggesting varying endotypes require differentiated treatment strategies. Approximately 20% of the patients studied are of the newly described IFNγ-driven sepsis (IDS) endotype. IDS is marked by elevated levels of CXCL9 and detection of IFNγ and poor clinical outcomes, with a 28-day mortality rate ranging from 40 to 43%. 

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. 

About Gamifant
Gamifant® (emapalumab) is an anti-interferon gamma (IFNγ) monoclonal antibody that binds to and neutralises IFNγ. When IFNγ is secreted in an uncontrolled manner, hyperinflammation occurs within the body. Gamifant is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT). 

In the USA, Gamifant is indicated for the treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Gamifant is also approved in the US for the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. 

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. 

About HISS   

The Hellenic Institute for the Study of Sepsis (HISS) is a non-profit, academic institute which fosters the activities of young researchers in the fields of systemic inflammation and sepsis. Since 2010, HISS has published 125 peer-reviewed publications including the publication of guidelines for sepsis in Greece, led the organization of 15 conferences, and of 35 clinical studies. HISS focuses on precision immunotherapy and is the Sponsor of the major randomized controlled trials SAVE-MORE and ImmunoSep. The data from these studies have been published in journals such as Nature Medicine and JAMA. 2,3. For more information, please visit https://sepsis.gr .

Sobi

Sobi® is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

Contacts

For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 6 PM CET on 7 January 2026. 

Reference 

1: Interferon-gamma-driven elevation of CXCL9: a new sepsis endotype independently associated with mortality. Giamarellos-Bourboulis, Evangelos J. et al. eBioMedicine, Volume 109, 105414 

2: Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial. Kyriazopoulou, Evdoxia et al. Nature Medicine 2021 Oct;27(10):1752-1760. 

3: Precision Immunotherapy to Improve Sepsis Outcomes. The ImmunoSep Randomized Clinical Trial. Giamarellos-Bourboulis EJ, et al. JAMA, DOI: 10.1001/jama.2025.24175.