Swiss pharmaceutical company Novartis AG (SIX:NOVN) (NYSE:NVS) announced on Monday that its global Phase III NEPTUNUS-1 and NEPTUNUS-2 trials evaluating ianalumab (VAY736) in adults with active Sjögren's disease met their primary endpoint, demonstrating statistically significant reductions in disease activity compared to placebo.

Sjögren's disease is a chronic autoimmune disorder causing inflammation and tissue damage of the exocrine glands that affects approximately 0.25% of the population. With no approved treatments currently, the results of the NEPTUNUS trials position ianalumab to potentially become the first targeted therapy approved for condition.

The trials measured improvements using the EULAR Sjögren's syndrome disease activity index (ESSDAI) and showed that ianalumab, which combines B-cell depletion with BAFF-R inhibition, was well tolerated with a favourable safety profile. Both studies enrolled patients with active extraglandular disease, and participants may continue in follow-up or transition to a long-term extension study.

Novartis plans to present the data at an upcoming medical congress and submit regulatory applications globally. Ianalumab, granted Fast Track Designation by the US Food and Drug Administration, is also in development for other B cell-driven autoimmune diseases including immune thrombocytopenia, systemic lupus erythematosus, and lupus nephritis.

The drug was originally developed through a collaboration with MorphoSys AG, which Novartis acquired in 2024.