InnoCare Pharma announced on October 4, 2024, that it has completed patient enrollment in a Phase II clinical trial for its novel BTK inhibitor, Orelabrutinib, for the treatment of Systemic Lupus Erythematosus (SLE). This randomized, double-blind, placebo-controlled, multicenter Phase IIb clinical study is designed to evaluate the efficacy and safety of Orelabrutinib in adult SLE patients. A total of 187 patients have been enrolled in the study, with a treatment duration of 48 weeks.
According to InnoCare Pharma’s press release, Orelabrutinib is a BTK inhibitor that has already shown efficacy in Phase 2 clinical trials for the treatment of SLE. The Phase IIa clinical trial of Orelabrutinib for SLE yielded positive results, with the study indicating a dose-dependent trend of improvement in the SLE Responder Index-4 (SRI-4), along with a downward trend observed in urinary protein and arthritis.
SLE is a systemic autoimmune disease that often leads to damage in multiple organs, particularly the kidneys and musculoskeletal system, nervous system, skin, hematopoietic system, respiratory system, and virtually every system can be affected. The “China Systemic Lupus Erythematosus Development Report 2020” points out that there are approximately one million SLE patients in China.- Flcube.com
