On August 11th, Novartis announced that its anti-BAFF-R monoclonal antibody Ianalumab (VAY736) met the primary endpoints in two Phase III clinical trials for patients with Sjögren's syndrome.
Currently, there are no approved systemic therapies for Sjögren's syndrome worldwide, and symptomatic treatments can only temporarily and partially relieve symptoms. Ianalumab is expected to end the history of "no targeted drugs available" for Sjögren's syndrome. Ianalumab is a novel fully human monoclonal antibody targeting the B lymphocyte activation factor receptor (BAFF-R). It eliminates B cells through antibody-dependent cell-mediated cytotoxicity (ADCC) while blocking BAFF-R-mediated B cell function and survival signals. The drug is sourced from Novartis' partner Morphosys, which was acquired by Novartis for €2.7 billion in 2024.
Currently, there are no approved systemic therapies for Sjögren's syndrome worldwide, and symptomatic treatments can only temporarily and partially relieve symptoms. Ianalumab is expected to end the history of "no targeted drugs available" for Sjögren's syndrome. Ianalumab is a novel fully human monoclonal antibody targeting the B lymphocyte activation factor receptor (BAFF-R). It eliminates B cells through antibody-dependent cell-mediated cytotoxicity (ADCC) while blocking BAFF-R-mediated B cell function and survival signals. The drug is sourced from Novartis' partner Morphosys, which was acquired by Novartis for €2.7 billion in 2024.
The drug is currently being developed for the treatment of various B cell-driven autoimmune diseases, including Sjögren's syndrome, immune thrombocytopenia (ITP), systemic lupus erythematosus (SLE), lupus nephritis (LN), warm antibody autoimmune hemolytic anemia (wAIHA), and diffuse cutaneous systemic sclerosis (dcSSc).
NEPTUNUS-1 and NEPTUNUS-2 are the first global Phase III clinical trials targeting Sjögren's syndrome. The primary endpoints were both assessed by the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) to measure improvements in systemic disease activity. Patients who completed the trials are eligible to enter a long-term extension study.
Results showed that both studies met their primary endpoints, with statistically significant improvements in disease activity in the Ianalumab group. Additionally, Ianalumab demonstrated good tolerability and safety.
Sjögren's syndrome is far more than a simple "dryness" issue; it is a chronic systemic autoimmune disease characterized by autoimmune destruction of exocrine glands. Patients exhibit highly variable clinical manifestations: mild cases may only present with bothersome dry eyes, dry mouth, and parotid gland enlargement, while severe cases can involve multi-organ system damage. Diagnosing the disease is extremely challenging, as its symptoms often overlap with other conditions, and dryness can stem from various causes, leading to frequent underdiagnosis or misdiagnosis, which significantly impairs patients' quality of life.
There has long been a huge unmet need in the treatment of Sjögren's syndrome. Globally, no specific drugs targeting the disease itself have been approved. Clinical treatment primarily relies on limited symptomatic therapies, which can only provide temporary and partial symptom relief. Although biotherapeutics have made breakthroughs in treating various autoimmune diseases in recent years, the development of biotherapeutics for Sjögren's syndrome has progressed relatively slowly, with no approved products yet. According to Yaozhi Data, among the global pipeline of biopharmaceuticals for Sjögren's syndrome, those that have entered Phase III clinical trials include Novartis' Ianalumab, argenx's efgartigimod, Johnson & Johnson's nipocalimab, Resolve Therapeutics' RSLV-132, Amgen's dazodalibep, BMS' abatacept, and from China,Rongchang Biotech's telitacicept.
Novartis stated that it will present the detailed data of the two studies at an upcoming medical conference and plans to submit a marketing application for Ianalumab. Previously, Ianalumab had received Fast Track designation from the U.S. FDA, and it is expected to become the first targeted therapy for Sjögren's disease, a chronic and disabling autoimmune disorder.
References:
1.https://www.novartis.com/news/media-releases/novartis-announces-both-ianalumab-phase-iii-clinical-trials-met-primary-endpoint-patients-sjogrens-disease
2. Yaozhi Data
