Novartis Hits Phase III Milestone with Ianalumab in Sjögren’s Disease

Novartis Hits Phase III Milestone with Ianalumab in Sjögren’s Disease

By, Admin 11 August 2025

Novartis has reported positive top-line results from two Phase III NEPTUNUS trials of ianalumab (VAY736) in adults with active Sjögren’s disease—meeting the primary endpoint of statistically significant improvements in disease activity.

If approved, ianalumab could become the first targeted systemic treatment for this chronic, disabling autoimmune condition.

The Big Win

  • Primary Endpoint Met: Reduction in disease activity measured by EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).
  • Dual Mechanism:
    - B-cell depletion via ADCC
    - BAFF-R inhibition (blocking B cell survival signals)
  • Safety: Well tolerated, favorable safety profile.

Trial Snapshot — NEPTUNUS Program

NEPTUNUS-1:

  • Design: Randomized, double-blind, 2-arm, N=275
  • Dosing: 300 mg subcutaneous, monthly vs. placebo for 52 weeks

NEPTUNUS-2:

  • Design: Randomized, double-blind, 3-arm, N=504
  • Dosing: 300 mg s.c. monthly OR every 3 months vs. placebo, up to 52 weeks

Next Steps: Data presentation at an upcoming medical meeting and global regulatory submissions (Fast Track status granted by FDA).

Why This Matters

  • Disease Burden: Affects ~0.25% of the population, ~50% undiagnosed, 9x more common in women.
  • Symptoms: Dry eyes, dry mouth, fatigue, pain; 30–40% have extraglandular organ involvement (skin, musculoskeletal, kidney, lung).
  • Risks: Higher lymphoma incidence.
  • Current Treatment Gap: No systemic approved therapies—only symptomatic, partial relief options.

The Molecule — Ianalumab (VAY736)

  • Type: Fully human monoclonal antibody
  • Pipeline Potential: Being studied in multiple B cell–driven autoimmune diseases, including ITP, SLE, lupus nephritis, wAIHA, and systemic sclerosis.
  • Origin: From early collaboration with MorphoSys AG (acquired by Novartis in 2024).

Quote — Dr. Shreeram Aradhye, CMO, Novartis:

“These Phase III studies mark a significant milestone. We look forward to engaging with health authorities to discuss these findings in the near future.”

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