argenx SE（ARGX）資訊與事件ARGXargenx SE

Argenx Discontinues Phase 3 Study of Efgartigimod

Argenx announced that it will discontinue the Phase 3 UNITY study of efgartigimod subcutaneous, or SC, in adults with moderate-to-severe Sjogren's disease. The decision is based on the recommendation from an Independent Data Monitoring Committee, or IDMC, to stop the study for futility following an interim analysis. The IDMC concluded that the UNITY study is unable to meet its primary endpoint. Safety was consistent with efgartigimod's established profile and no new safety signals were identified.

Argenx Announces Phase 2 Study Results for FB102

Argenx announced topline results from the Phase 2 study evaluating FB102, a CD122 inhibitor, in adults with celiac disease. These results represent the first clinical readout of FB102 following Argenx's acquisition of Forte Biosciences in August. Patients treated with FB102 demonstrated a statistically significant and clinically relevant treatment effect compared to placebo. The study met its primary endpoint of change from baseline in the ratio of villus height-to-crypt depth at day 78 versus placebo in adults with celiac disease undergoing a gluten challenge. Broad efficacy measures, including intraepithelial lymphocyte, or IEL, density, villus height-to-crypt depth intraepithelial lymphocyte, or VCIEL, composite score, and symptoms, were consistent with the primary endpoint, providing additional evidence of effect across histologic, inflammatory, and clinical measures. The observed safety profile was consistent with prior studies and the known safety profile of FB102, with no new safety signals identified.