China-based pharmaceutical company RemeGen (HKG: 9995) has announced the completion of patient enrollment in a Phase III clinical study for its drug candidate telitacicept in primary Sjogren’s syndrome (pSS) in China. The study aims to evaluate the efficacy and safety of telitacicept in pSS, with a total of 381 patients enrolled. The primary endpoint is the change in the ESSDAI score, a gold standard measure of disease activity in Sjogren’s syndrome, from baseline at week 24 of treatment.
Primary Sjogren’s syndrome (pSS) is a chronic inflammatory autoimmune disease that primarily affects secretory glands, such as the lacrimal and salivary glands, and currently lacks effective treatment options. Telitacicept is a novel recombinant fusion protein that targets both B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). It inhibits the maturation and differentiation of B cells, reduces the secretion of autoantibodies, and better controls the activity of pSS. In a Phase II study, telitacicept demonstrated significant improvements in ESSDAI scores and MFI-20 for pSS patients compared to placebo, reduced overall immunoglobulin levels, and showed a favorable safety profile. The drug was granted fast-track status for use in pSS in the US last month.
Telitacicept received conditional approval in China to treat systemic lupus erythematosus (SLE) in March 2021, which was converted to full approval in November 2023. It was included in the National Reimbursement Drug List (NRDL) at the end of 2021. The drug is also being assessed in multiple clinical studies for Myasthenia gravis, rheumatoid arthritis, and other indications beyond SLE and pSS.- Flcube.com
