Novartis has shared positive top-line results from two late-stage trials of its investigational monoclonal antibody ianalumab in Sjögren’s syndrome.
The phase 3 NEPTUNUS-1 and NEPTUNUS-2 trials have been evaluating the safety and efficacy of the drug in a total of 779 patients with the systemic autoimmune disease.
Approximately 0.6% of the UK’s adult population is affected by Sjögren’s syndrome, a B cell-driven disease that causes inflammation and tissue damage.
The condition primarily affects the exocrine glands, with more than 90% of patients experiencing dry eyes and mouth. Symptoms also include aching muscles and joints, fatigue and widespread pain.
Both NEPTUNUS met the primary endpoint of improving disease activity, as assessed by a multi-dimensional disease activity measurement, compared to placebo.
The candidate was also found to be well tolerated and demonstrated a favourable safety profile, Novartis said, adding that data from the trials will be presented at an upcoming medical congress.
Ianalumab has a dual mechanism of action, B-cell depletion and BAFF-R inhibition, and is being investigated across various B cell-driven autoimmune diseases, including immune thrombocytopenia and systemic lupus erythematosus.
The drug has the potential to become the first targeted treatment for patients with Sjögren’s syndrome, according to Novartis.
Shreeram Aradhye, president of development and chief medical officer at Novartis, 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 3 trials demonstrate that ianalumab improves disease activity in patients with Sjogren’s disease.”
Aradhye added that the company is “[looking] forward to engaging with health authorities to discuss these findings in the near future”.
Inflammatory diseases are a key focus area for Novartis, which recently entered into a partnership worth $1bn with Matchpoint Therapeutics to develop oral inhibitors for inflammatory diseases that have been historically difficult to treat.
The company also entered into an agreement with Kyorin Pharmaceutical in March to gain exclusive worldwide rights to a pre-clinical candidate for chronic spontaneous urticaria and other allergic and inflammatory diseases involving mast cells.