China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced positive results from the China Phase III clinical study for its telitacicept in the treatment of rheumatoid arthritis (RA). Following these results, the company has submitted a supplementary New Drug Application (sNDA) to the Center for Drug Evaluation (CDE). Previously, the novel fusion protein was approved to treat systemic lupus erythematosus (SLE) in China in March 2021.
Phase III Clinical Study Design and Outcomes
The randomized, double-blind, placebo-controlled, multi-center Phase III clinical study enrolled 479 RA patients. The study demonstrated that at week 24, the ACR20 response rate was significantly higher in patients receiving telitacicept (160mg) in combination with methotrexate compared to those receiving methotrexate alone, successfully meeting the primary efficacy endpoint.
Telitacicept’s Mechanism and Previous Approvals
Telitacicept is a novel recombinant fusion protein that targets both B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). It was conditionally approved in China to treat systemic lupus erythematosus (SLE) in March 2021. The drug’s potential is currently being explored in Phase III clinical studies for additional indications, including IgA nephropathy, optic neuromyelitis spectrum disease, primary Sjogren’s syndrome, myasthenia gravis, and multiple sclerosis.-Fineline Info & Tech
