Novartis' Ianalumab Meets Primary Endpoints in Phase III Trials for Sjögren's Disease, Reinforcing Potential as First Targeted Therapy.

Novartis' ianalumab has met primary endpoints in Phase III trials for Sjögren's disease, showing significant improvements in disease activity. The dual-action therapy combines B-cell depletion with BAFF-R inhibition to address immune dysfunction in patients. The results are a major step forward in developing precision treatments for autoimmune disorders.

Basel, Switzerland - July 2, 2025 - Novartis announced positive top-line results from its Phase III trials evaluating ianalumab (VAY736) in adults with active Sjögren's disease. Both trials, NEPTUNUS-1 and NEPTUNUS-2, met their primary endpoint, demonstrating statistically significant improvements in disease activity compared to placebo [1].

Ianalumab, a novel fully human monoclonal antibody, targets B cells in two ways: combining B cell depletion via antibody-dependent cellular toxicity (ADCC) and interruption of BAFF-R mediated signals of B cell function and survival [2]. The dual-action therapy showed promising efficacy and a favorable safety profile in clinical trials for Sjögren's disease, systemic lupus erythematosus, and immune thrombocytopenia [3].

The NEPTUNUS-1 and NEPTUNUS-2 trials were global, multicenter, pivotal studies evaluating the efficacy and safety of ianalumab in patients with Sjögren's disease. NEPTUNUS-1 was a randomized, double-blind, 2-arm multicenter phase III trial (N=275), while NEPTUNUS-2 was a randomized, double-blind, 3-arm multicenter phase III trial (N=504). The primary endpoint was measured by improvements in systemic disease activity using the EULAR Sjögren’s syndrome disease activity index (ESSDAI) [4].

Sjögren's disease is a chronic, disabling autoimmune disease that affects approximately 0.25 percent of the population, with an estimated 50 percent undiagnosed. The disease is characterized by excessive dryness of the eyes and mouth, fatigue, and widespread pain, with 30-40 percent of patients also showing extraglandular organ involvement [5]. The results from the Phase III trials represent a significant milestone in developing precision treatments for autoimmune disorders.

Novartis plans to present the NEPTUNUS-1 and NEPTUNUS-2 data at an upcoming medical congress and submit ianalumab, which was granted Fast Track Designation by the US Food and Drug Administration (FDA), to health authorities globally [6]. The company looks forward to engaging with health authorities to discuss these findings in the near future.

References:
[1] https://www.novartis.com/news/media-releases/novartis-announces-both-ianalumab-phase-iii-clinical-trials-met-primary-endpoint-patients-sjogrens-disease
[2] Bowman S et al, Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjogren’s syndrome: a randomized, double-blind, placebo-controlled, phase 2b dose-finding trial, Lancet 2022; 399:161-71
[3] Dorner T et al, Safety and Efficacy of ianalumab in patients with Sjogren’s disease:52-week results from a randomized, placebo-controlled, phase 2b dose-ranging study, Arhtritis and Rheumatology 2025, 77(5):560-570
[4] Negrini S et al, Sjogren’s syndrome: a systemic autoimmune disease, Clin Exp Med. 2022; 22(1): 9–25
[5] Mariette, Primary Sjogren’s symptoms, New England Journal of Medecine, 2018, 378;10
[6] VAY736, Department of health and human Services, Fast Track Designation, US Food and Drug Administration, 2025