Expert: Fully human IgG1 monoclonal antibody that binds and neutralizes interferon-gamma (IFNg). IFNg is the pivotal cytokine driving the hyperinflammatory cascade in HLH/MAS, activating macrophages and inducing further pro-inflammatory cytokine release (IL-18, CXCL9, CXCL10). Neutralization breaks the positive feedback loop of macrophage activation.

Everyday: Blocks a specific immune alarm signal (interferon-gamma) that can cause the immune system to spiral out of control. Normally interferon-gamma helps fight infections, but in diseases like HLH it gets stuck in "maximum overdrive" — this drug is like cutting the wire to the alarm that won't stop ringing.

Targets: []

Primary EP: [{"id":"emerald-ep1","name":"Complete response at Week 8","type":"PRIMARY","unit":"%","results":[{"arm":"emerald-ema","label":"54% (21/39) CR at Week 8","value":54}],"timepoint":"Week 8","description"

Safety: 6 serious adverse drug reactions in 4 patients. 14 infusion-related reactions in 8 patients (none serious, none led to discontinuation). No new safety concerns beyond known HLH label.

Primary EP: [{"id":"embrace-ep1","name":"Improvement in organ dysfunction and survival","type":"PRIMARY","results":[{"arm":"embrace-ema","label":"Positive POC: improvement in organ dysfunction and survival"}],"de

Efficacy: Pooled Phase 2+3 open-label studies (N=39). Complete Response (CR) at Week 8: 53.8% (95% CI: 37.2-69.9%). CR at any time: 85% (33/39). Overall Response at Week 8: 82.4%. Clinical MAS remission: 82.1%; median time 3.3 weeks. Survival at Week 8: 94.9% (37/39). Glucocorticoid tapering: baseline 9.7 mg/

Safety: Pooled (N=39). Serious ADRs: 6 events in 4 patients. Infusion-related reactions: 14 events in 8 patients (none serious, none led to discontinuation). Most common AEs (>=20%): viral infections (CMV rea

Primary EP: [{"id":"gami-ep1","name":"Overall response rate (previously treated)","type":"PRIMARY","unit":"%","p_value":"0.013 (vs null hypothesis of 40%)","results":[{"n":"17/27","ci":"42-81","arm":"gami-ptx","l

Safety: Infections 56% (expected given HLH-associated immunosuppression). Infusion reactions 27% (8% mild, 5% moderate; one-third at first infusion). Hypertension 41%. Pyrexia 24%. 1 discontinuation due to AE

Gamifant - IFN-gamma-driven Sepsis - Ph2b/3 Design Discussion 2026

First and only anti-IFN-gamma antibody. Approved for primary HLH (Nov 2018) and HLH/MAS in Still's disease (Jun 2025). The Jun 2025 MAS/Still's approval significantly expanded the addressable market. PLATFORM POTENTIAL: IFN-gamma is the key driver in multiple hyperinflammatory conditions. EMBRACE Phase 2a in IFN-gamma driven sepsis (IDS) showed proof of concept (Jan 2026) — if this pathway succeeds, addressable market expands from ultra-rare to massive (sepsis: ~1.7M hospitalizations/yr in US). SOBI and HISS (Greek research institute) discussing next steps with regulators.