NEPTUNUS-1 and NEPTUNUS-2 are the first ever global Phase III trials to demonstrate statistically significant reduction in disease activity for Sjögren’s disease
Novartis announced positive top-line results from its Phase III trials evaluating ianalumab (VAY736) in adults with active Sjögren’s disease. Both trials met the primary endpoint of demonstrating statistically significant improvements in disease activity. These results support the potential for ianalumab, a drug with a dual mechanism of action, B-cell depletion and BAFF-R inhibition, to become the first targeted treatment for patients with Sjögren’s disease, a chronic, disabling autoimmune disease.
Health Technology Insights: OMass Therapeutics Appoints Carol Schafer as Audit Chair
“Sjögren’s disease is a serious, progressive, systemic autoimmune disease, often unrecognized or misdiagnosed with a significant detrimental impact to quality of life, with very limited treatment options and an established unmet need. Both Phase III trials demonstrate that ianalumab improves disease activity in patients with Sjögren’s disease,” said Shreeram Aradhye, M.D., President of Development and Chief Medical Officer at Novartis. “These Phase III studies mark a significant milestone. We look forward to engaging with health authorities to discuss these findings in the near future.”
The NEPTUNUS pivotal trials achieved the primary endpoint of improving disease activity measured by a reduction in EULAR Sjögren’s syndrome disease activity index (ESSDAI), a multi-dimensional disease activity measurement compared to placebo1. Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren’s disease,
Health Technology Insights: BioXcel Publishes Study on Dexmedetomidine and Stress Behaviors
Novartis plans to present the NEPTUNUS-1 and NEPTUNUS-2 data at an upcoming medical meeting and submit ianalumab, which was granted Fast Track Designation by the US Food and Drug Administration (FDA), to health authorities globally6.
About ianalumab
Ianalumab (VAY736) is a novel fully human monoclonal antibody being investigated for its potential to treat various B cell-driven autoimmune diseases, including Sjögren’s disease, immune thrombocytopenia (ITP), systemic lupus erythematosus (SLE), lupus nephritis (LN), warm autoimmune hemolytic anemia (wAIHA) and diffuse cutaneous systemic sclerosis (dcSSc). Its mechanism of action targets B cells in two ways, namely combining B cell depletion via antibody-dependent cellular toxicity (ADCC) and interruption of BAFF-R mediated signals of B cell function and survival. In clinical trials, ianalumab showed promising efficacy and a favorable safety profile in Sjögren’s disease, systemic lupus erythematosus, and immune thrombocytopenia. Ianalumab originates from an early collaboration with MorphoSys AG, a company which Novartis later acquired in 2024
About Sjögren’s disease (previously called Sjögren’s syndrome)
Sjögren’s disease is a systemic, chronic autoimmune disorder that causes inflammation and tissue damage, impacting the entire body. It primarily affects exocrine glands, leading to excessive dryness, with over 90 percent of patients experiencing dry eyes and dry mouth. The disease is heterogenous, patients experience dryness, fatigue and widespread pain and 30-40 percent of patients will also show extraglandular organ involvement. Extraglandular manifestation can be very diverse and can affect skin, musculoskeletal system, kidneys, lungs and other organs. The risk of lymphoma is increased in patients with Sjögren’s
Health Technology Insights: Facephi Unveils AI Defense Tool Against Deepfakes, Attacks
To participate in our interviews, please write to our HealthTech Media Room at sudipto@intentamplify.com
Source- PR Newswire
