Novartis has reported that both of its pivotal Phase III clinical trials—NEPTUNUS-1 and NEPTUNUS-2—have successfully met their primary endpoint in adults with active Sjögren’s disease. These are the first global Phase III studies to show a statistically significant reduction in disease activity in this patient group.
Trial Highlights
- NEPTUNUS-1 (n = 275) and NEPTUNUS-2 (n = 504) demonstrated meaningful decreases in systemic disease activity, measured by the EULAR Sjögren’s syndrome disease activity index (ESSDAI), versus placebo.
- Ianalumab’s dual mechanism—B-cell depletion via antibody-dependent cellular cytotoxicity and inhibition of BAFF-R signalling—targets two key drivers of Sjögren’s pathology.
- The therapy was well tolerated, with a favourable safety profile across both trials.
- Top-line data support ianalumab’s potential to become the first approved targeted treatment for Sjögren’s disease.
What This Means for Patients
- First-ever approved therapy on the horizon: If approved, ianalumab could fill a major treatment gap for a disease that currently lacks systemic, disease-modifying options.
- Validated benefit: Positive results in two distinct patient subgroups—those with high systemic activity and those with a high burden of symptoms—underscore ianalumab’s broad applicability.
- Next steps: Novartis plans to present full data at an upcoming medical congress and will submit regulatory filings to health authorities worldwide, including the U.S. Food and Drug Administration (FDA), where ianalumab holds Fast Track designation.
About Ianalumab
Ianalumab (VAY736) is a fully human monoclonal antibody originally developed by MorphoSys AG and later acquired by Novartis. Beyond Sjögren’s disease, it is under investigation for several B cell-driven autoimmune conditions, including systemic lupus erythematosus and immune thrombocytopenia.
Sjögren’s UK Perspective
We welcome Novartis’s announcement as a landmark moment in Sjögren’s research. Achieving the first positive Phase III results in this disease offers real hope to patients and their families. Sjögren’s UK will continue to monitor regulatory developments and share updates on potential treatments as they progress toward approval.
