InnoCare Pharma achieves primary endpoint in Phase 2b study of orelabrutinib

Zenas BioPharma (ZBIO) announced that its partner, InnoCare Pharma (INCPF) announced the achievement of the primary endpoint in a Phase 2b study of orelabrutinib, a highly selective CNS-penetrant, oral, small molecule BTK inhibitor, in patients with Systemic Lupus Erythematosus. InnoCare also received approval from China’s Center for Drug Evaluation to conduct a Phase 3 registrational clinical trial as InnoCare develops orelabrutinib for the treatment of SLE in China. In the Phase 2b study of orelabrutinib, a total of 187 patients were enrolled and randomized into three groups: orelabrutinib 75 mg once-daily, orelabrutinib 50 mg QD and placebo. The primary endpoint of the study was the SLE Response Index-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, 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 response rates compared to the placebo group, 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. Results of a previous Phase 2a clinical trial of orelabrutinib for SLE were previously presented as a late breaking oral presentation at the European Union Congress of Rheumatology