[{"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"}],"description":"Proof-of-concept endpoint. Positive topline reported Jan 7, 2026, showing improvement in organ dysfunction markers and survival in patients with IFN-gamma-driven sepsis (IDS)."}]

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/kg/day reduced to 0.8 mg/kg/day at Week 8; 72% tapered to <=1 mg/kg/day. Phase 2 subset (N=14): 0 deaths through 12-month follow-up. FDA approved June 2025 — first-ever treatment for MAS in Still’s disease.

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 reactivation in 43% of Phase 2 patients), rash. Phase 2 (N=14): AEs in 93%, SAEs in 43% (9 events in 6 pts). Bacterial/opportunistic infections: 0. sJIA/AOSD flares during treatment: 43%. Discontinuation due to AEs: 0%. Lab: ferritin normalized from 25,709 to 55 ng/mL at Week 8 (>99% reduction).

EMBRACE is the long-term optionality play. Sepsis TAM is enormous but this is the graveyard of failed drug trials. SOBI's differentiated approach (precision medicine, IFN-gamma biomarker) is why this might be different. Phase 2b/3 design TBD 2026. Revenue impact not until 2029+ at earliest. Featured at CMD Feb 18 with Prof. Giamarellos discussing precision medicine in sepsis.

Precision medicine approach: identify sepsis patients with elevated IFN-gamma (IDS subpopulation) and block the key driver. Sepsis kills ~270,000/year in the US alone with ZERO approved targeted therapies. If the IDS subpopulation can be identified with a companion diagnostic, this is transformational.