Novartis AG ( NVS ) on Monday released topline data from two Phase 3 trials, NEPTUNUS-1 and NEPTUNUS-2, 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.

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Sjögren’s disease is a chronic autoimmune disorder that primarily affects the moisture-producing glands, leading to dry eyes and mouth. 

The NEPTUNUS pivotal trials achieved the primary endpoint of improving disease activity measured by reducing EULAR Sjögren’s syndrome disease activity index (ESSDAI), a multi-dimensional disease activity measurement compared to placebo.

Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren’s disease.

Novartis ( NVS ) 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 U.S. Food and Drug Administration (FDA), to health authorities globally.

In March this year, the U.S. Food and Drug Administration granted Fast Track designation to Johnson & Johnson’s investigational nipocalimab for moderate-to-severe Sjögren’s disease.

The Phase 2 DAHLIAS study, presented last year, represented the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy in SjD. 

The study achieved the primary endpoint in the 15 mg/kg Q2W nipocalimab group, showing a greater than 70% relative average improvement in systemic disease activity at Week 24 compared to placebo and IgG reductions of more than 77%.

Price Action: NVS stock is trading higher by 1.22% to $118.27 at last check Monday.

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