Novartis said that the Phase 3 NEPTUNUS-1 and NEPTUNUS-2 trials, investigating its monoclonal antibody ianalumab (VAY736) in Sjögren’s disease, have met their primary endpoints.
NEPTUNUS-1 and NEPTUNUS-2 are randomised, double-blind clinical trials evaluating the efficacy and safety of ianalumab in treating adults with active Sjögren’s disease. This chronic autoimmune disorder causes systemic inflammation and tissue damage, primarily affecting exocrine glands.
The primary endpoints of the two trials were measured by improvements in disease activity using the EULAR Sjögren’s syndrome disease activity index (ESSDAI) compared to a placebo.
In the studies, ianalumab was well tolerated, showing a promising safety profile.
The NEPTUNUS-1 trial involved 275 patients. It investigated ianalumab 300 mg subcutaneous (s.c.) monthly, in comparison with placebo, for a period of 52 weeks.
NEPTUNUS-2 is a three-arm trial featuring 504 patients. It evaluated 300 mg s.c. of ianalumab monthly or every three months, in comparison with placebo for up to 52 weeks.
Novartis intends to present the findings of the two trials at an upcoming medical congress and will seek approval from health authorities worldwide.
Novartis development president and chief medical officer Shreeram Aradhye said: “Sjögren’s disease is a serious, progressive, systemic autoimmune disease, often unrecognised 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.
“These Phase III studies mark a significant milestone. We look forward to engaging with health authorities to discuss these findings in the near future.”
Ianalumab is a fully human monoclonal antibody that targets B cells through dual mechanisms, involving B cell depletion and BAFF-R inhibition.
The drug candidate is being studied for its potential in treating various B cell-driven autoimmune diseases. It has shown efficacy in treating conditions like systemic lupus erythematosus and immune thrombocytopenia.
According to Novartis, ianalumab could become the first targeted treatment approved for Sjögren’s disease.
Last month, Novartis signed a licensing deal with US-based Matchpoint Therapeutics to develop oral inhibitors targeting inflammatory diseases.
