Novartis has 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.
"Sjögren's disease is a serious, progressive, systemic autoimmune disease, often unrecognised or misdiagnosed, with a significant detrimental impact on quality of life ... with minimal 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, MD, 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 shortly."
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 multidimensional disease activity measurement compared with a placebo.
Ianalumab was well tolerated and demonstrated a favourable safety profile in Sjögren's disease.
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 globally.