Sobi Advances Gamifant for Interferon-Gamma-Driven Sepsis
Today, Sobi® (STO: SOBI) confirmed the encouraging topline results from their Phase 2a EMBRACE study, which evaluated Gamifant® (emapalumab) for treating interferon-gamma (IFN?)-driven sepsis (IDS). These findings provide valuable proof-of-concept, revealing significant improvements in organ function and survival rates among patients.
In collaboration with the Hellenic Institute for the Study of Sepsis (HISS), Sobi plans to further advance the clinical development of emapalumab in treating IDS and will engage with regulatory agencies to discuss subsequent steps. Updates regarding the research findings will be shared at future medical conferences as they become available.
Understanding Sepsis and IFN?-Driven Sepsis (IDS)
Sepsis represents a critical condition that arises following an infection, potentially leading to organ failure, and is a major cause of death worldwide. Recent research has highlighted various sepsis endotypes, indicating diverse treatment strategies may be necessary. Approximately 20% of patients experience the newly identified IFN?-driven sepsis (IDS) endotype, characterized by elevated CXCL9 levels and detectable IFN?, associated with severe clinical outcomes, including a 28-day mortality rate between 40% and 43%.
Insights on the EMBRACE Study
The EMBRACE study (NCT06694701) was a Phase 2a randomized controlled trial executed at 24 sites throughout Greece. Sponsored by HISS in partnership with Sobi, the trial aimed to determine whether Gamifant, an anti-IFN? monoclonal antibody, could enhance clinical outcomes for patients specifically diagnosed with the IDS endotype, while avoiding sepsis-induced immunoparalysis. The study design included three arms, enrolling 75 patients, with two groups receiving different doses of Gamifant alongside standard treatment, and a placebo group receiving standard care only.
The primary endpoint was to achieve at least a 1.4-point decline in the Sequential Organ Failure Assessment (SOFA) score over 28 days, while secondary endpoints encompassed 28-day mortality, patient safety, pharmacokinetics, and altering key inflammatory biomarkers such as CRP, IL-6, ferritin, IFN?, and CXCL9.
About Gamifant
Gamifant® (emapalumab) functions as an anti-interferon gamma (IFN?) monoclonal antibody that effectively binds and neutralizes IFN? within the body. IFN? is often secreted uncontrollably, leading to hyperinflammatory responses. Gamifant is administered through intravenous infusion over a one-hour duration, twice weekly, until hematopoietic stem cell transplantation (HSCT) is performed.
In the United States, Gamifant is prescribed for both adult and pediatric patients facing primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive symptoms, or who are intolerant to standard HLH therapies. It is also recognized in treating adult and pediatric patients showcasing hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) related to Still's disease, particularly when previous glucocorticoid treatments have been inadequate.
Primary HLH is a rare hyperinflammatory syndrome typically occurring during the first year of life, carrying a high risk of fatality without prompt diagnosis and intervention.
About HISS
The Hellenic Institute for the Study of Sepsis (HISS) operates as a non-profit academic institution, dedicated to nurturing young researchers and advancing knowledge in systemic inflammation and sepsis. Since 2010, HISS has contributed to the publication of 125 peer-reviewed articles, established sepsis guidelines in Greece, organized 15 conferences, and led 35 clinical studies. Their research emphasizes precision immunotherapy, being the sponsor for major randomized controlled trials like SAVE-MORE and ImmunoSep. Results from these studies are documented in esteemed journals.
Sobi® is a global biopharmaceutical company dedicated to unlocking breakthrough innovations that can transform the lives of those dealing with rare diseases. The company employs approximately 1,900 individuals across various regions, including Europe, North America, the Middle East, Asia, and Australia. In a recent fiscal year, Sobi reported revenues amounting to SEK 26 billion. The company’s stock (STO:SOBI) is publicly listed on Nasdaq Stockholm. To learn more about Sobi, please visit their official website.
Frequently Asked Questions
What is the significance of the EMBRACE study results?
The EMBRACE study demonstrated that Gamifant could improve organ dysfunction and survival rates in patients with interferon-gamma-driven sepsis.
How does Gamifant work?
Gamifant is an anti-IFN? monoclonal antibody that binds to IFN?, neutralizing its uncontrolled secretion that causes hyperinflammation.
What are the potential outcomes for patients treated with Gamifant?
Patients treated with Gamifant may experience improved organ function and reduced mortality rates, according to the EMBRACE study findings.
Who sponsors the EMBRACE study?
The Hellenic Institute for the Study of Sepsis (HISS) sponsors the EMBRACE study in collaboration with Sobi.
What type of patients can be treated with Gamifant in the USA?
Gamifant is indicated for adult and pediatric patients suffering from primary HLH and those facing complications due to Still's disease.
