Key Highlights:
- Novartis announced on August 11, 2025, that both Phase III NEPTUNUS-1 and NEPTUNUS-2 trials of ianalumab met their primary endpoints, showing statistically significant improvement in disease activity measured by ESSDAI in patients with active Sjögren’s disease.
- Ianalumab demonstrated a favorable safety profile and good tolerability, reinforcing its potential as the first targeted therapy for this chronic autoimmune disorder with high unmet need.
- Novartis plans to present detailed data at upcoming medical congresses and pursue global regulatory approvals, leveraging FDA Fast Track Designation for accelerated development.
Positive Phase III Results Confirm Efficacy in Sjögren’s Disease
The NEPTUNUS-1 (275 patients) and NEPTUNUS-2 (504 patients) trials evaluated monthly or quarterly subcutaneous doses of ianalumab versus placebo over 52 weeks. Both trials demonstrated statistically significant reductions in systemic disease activity using the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI), a comprehensive clinical measure. These results affirm ianalumab’s ability to improve symptoms and systemic inflammation in patients with active extraglandular disease manifestations.
Dual Mechanism Targeting B Cells Drives Therapeutic Potential
Ianalumab (VAY736) is a fully human monoclonal antibody designed to deplete B cells through antibody-dependent cellular cytotoxicity (ADCC) and inhibit BAFF receptor signaling, critical in B-cell survival and function. This dual-action approach addresses key pathogenic mechanisms underlying Sjögren’s disease and other B cell-driven autoimmune disorders including systemic lupus erythematosus (SLE) and immune thrombocytopenia (ITP).
Safety and Tolerability Profile Supports Clinical Use
Across both pivotal studies, ianalumab was well tolerated with a favorable safety profile consistent with previous trials. No new safety signals emerged, supporting the suitability of this novel therapy for long-term management of a heterogeneous patient population facing limited treatment options beyond symptomatic relief.
Next Steps: Regulatory Engagement and Clinical Presentations
Building on the success of NEPTUNUS trials and the FDA Fast Track status, Novartis is preparing to present comprehensive efficacy and safety data at upcoming medical congresses. The company intends to submit ianalumab for regulatory review globally, aiming to deliver the first approved targeted systemic therapy for Sjögren’s disease, addressing a significant unmet medical need for patients worldwide.
This milestone advances Novartis’ commitment to reimagine medicine and provide transformative treatment options for chronic autoimmune diseases through cutting-edge biologic innovation.
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