• EN

    • -+ 0.00%
    -+ 0.00%
    -+ 0.00%

    Zenas BioPharma's partner, InnoCare Pharma announced the achievement of the primary endpoint in Phase 2b study of orelabrutinib for Systemic Lupus Erythematosus.

    Benzinga·12/15/2025 12:18:15
    Listen to the news
    • Orelabrutinib is the first BTK inhibitor to demonstrate significant clinical activity in a Phase 2 clinical trial for SLE.
    • In the Phase 2b study of orelabrutinib, a total of 187 patients were enrolled and randomized (1:1:1) into three groups: orelabrutinib 75 mg once-daily (QD), orelabrutinib 50 mg QD and placebo. 
    • The primary endpoint of the study was the SLE Response Index-4 (SRI-4) response rate at week 48. At week 48, the orelabrutinib 75 mg QD group achieved a statistically significant improvement in SRI-4 response rate compared with placebo (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. Additionally, a dose-dependent improvement trend of the orelabrutinib 75 mg QD group compared to the 50 mg QD group was observed.
    • At week 48, the orelabrutinib 75 mg QD group demonstrated significantly higher SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates compared to the placebo group (p < 0.05), meeting these secondary endpoints.
    • Orelabrutinib was well tolerated with a safety profile consistent with the mechanism of action of BTK inhibition and the underlying disease biology of SLE.
    • Zenas acquired the exclusive right to develop, manufacture and commercialize orelabrutinib in the field of Multiple Sclerosis globally, and non-oncology fields in all territories outside Greater China and Southeast Asia, in October 2025 license agreement with InnoCare.
    • InnoCare also received approval from China's Center for Drug Evaluation (CDE) to conduct a Phase 3 registrational clinical trial as InnoCare develops orelabrutinib for the treatment of SLE in China.