Novartis has reported positive top-line results from its Phase III NEPTUNUS trials evaluating ianalumab (VAY736) in adults with active Sjögren’s disease. Both studies met their primary endpoint, showing statistically significant improvements in disease activity compared to placebo, as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).
Ianalumab, a monoclonal antibody with a dual mechanism of B-cell depletion and BAFF-R inhibition, could become the first targeted therapy for this chronic, progressive autoimmune condition, which has few treatment options and a significant impact on quality of life. The therapy was well tolerated and demonstrated a favorable safety profile.
Granted Fast Track Designation by the US FDA, ianalumab is also under investigation for multiple B cell-driven autoimmune diseases. Novartis plans to present the full NEPTUNUS-1 and NEPTUNUS-2 results at an upcoming medical meeting and submit the drug for global regulatory approvals.