Novartis announced positive Phase III results for BAFF-R inhibitor ianalumab in two global trials (NEPTUNUS-1 and NEPTUNUS-2) involving 550 patients with active Sjögren's syndrome. The fully human monoclonal antibody (mAb) achieved statistically significant improvements in EULAR Sjögren's Syndrome Disease Activity Index scores at 52 weeks versus placebo across monthly and quarterly dosing regimens. Ianalumab depletes B cells while blocking BAFF-R signalling, addressing glandular and systemic manifestations of this autoimmune disease affecting 0.25% of adults, predominantly women.

As the first targeted therapy to demonstrate efficacy in Sjögren's syndrome, ianalumab could transform a treatment landscape currently limited to symptom management. Novartis plans regulatory submissions following full data presentation at upcoming medical conferences. The antibody also shows promise in Phase II trials for systemic lupus erythematosus (SLE) and immune thrombocytopenia, expanding its potential across autoimmune disorders.

PharmCube's NextBiopharm® database shows that ianalumab is being developed in a total of 15 indications. Click here to request a free trial for NextBiopharm®.