Novartis: Ianalumab Phase III Trials Achieve Primary Endpoint in Sjögren’s Disease Patients

Ad hoc announcement pursuant to Art. 53 LR

NEPTUNUS-1 and NEPTUNUS-2 are the first ever global Phase III trials to demonstrate statistically significant reduction in disease activity for Sjögren’s disease¹
Ianalumab has the potential to become the first and only targeted treatment approved for patients with Sjögren’s disease
Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren’s disease^1,2
Novartis plans to present its data at an upcoming medical congress and submit to health authorities globally

EAST HANOVER, N.J., Aug. 11, 2025 /PRNewswire/ — Novartis (NVS) shares are in focus today following the announcement of positive top-line results from its Phase III trials evaluating ianalumab (VAY736) in adults battling active Sjögren’s disease. The Swiss pharmaceutical giant confirmed that both trials met their primary endpoint, demonstrating statistically significant improvements in disease activity¹. The news fuels hopes for ianalumab, a drug boasting a dual mechanism of action – B-cell depletion combined with BAFF-R inhibition – potentially becoming the first targeted treatment option for Sjögren’s disease, a chronic autoimmune condition affecting millions.

“Sjögren’s disease is a debilitating and often misdiagnosed autoimmune disorder that significantly impacts patients’ quality of life. Current treatment options are limited, highlighting a considerable unmet need,” stated Shreeram Aradhye, M.D., President of Development and Chief Medical Officer at Novartis. “These Phase III results, demonstrating ianalumab’s ability to improve disease activity, represent a significant milestone. We anticipate productive discussions with global health authorities in the near future.”

Specifically, the NEPTUNUS pivotal trials achieved their primary endpoint by showcasing improvements in disease activity, as measured by a reduction in the EULAR Sjögren’s syndrome disease activity index (ESSDAI) compared to placebo¹. Furthermore, Ianalumab exhibited a favorable safety profile and was well-tolerated during the trials^1,2.

Looking ahead, Novartis aims to unveil the complete NEPTUNUS-1 and NEPTUNUS-2 data at an upcoming medical meeting. The company also plans to submit ianalumab, already granted Fast Track Designation by the US Food and Drug Administration (FDA)⁶, to regulatory agencies worldwide.

Diving Deeper: About Ianalumab

Ianalumab (VAY736) is an investigational, fully human monoclonal antibody poised to potentially revolutionize the treatment landscape for various B cell-driven autoimmune diseases. Beyond Sjögren’s disease, it’s being explored for immune thrombocytopenia (ITP), systemic lupus erythematosus (SLE), lupus nephritis (LN), warm autoimmune hemolytic anemia (wAIHA), and diffuse cutaneous systemic sclerosis (dcSSc) ^3,7-13. The drug’s unique mechanism of action tackles B cells through two distinct pathways: antibody-dependent cellular toxicity (ADCC) leading to B cell depletion, and the disruption of BAFF-R mediated signals essential for B cell function and survival³. Clinical trials have revealed promising efficacy and a favorable safety profile for ianalumab in Sjögren’s disease, systemic lupus erythematosus, and immune thrombocytopenia^2,14,15. Interestingly, Ianalumab’s origins trace back to a collaboration with MorphoSys AG, a company that Novartis acquired in 2024¹⁶, further bolstering its pipeline.

NEPTUNUS-1 and NEPTUNUS-2: A Closer Look

The NEPTUNUS-1 and NEPTUNUS-2 Phase III clinical trials, conducted globally across multiple centers, stand as pivotal studies evaluating ianalumab’s efficacy and safety in patients with Sjögren’s disease^7,8. These trials were meticulously crafted to deliver comprehensive data on ianalumab’s potential as a targeted treatment for patients with active extraglandular disease^3,7,8.

NEPTUNUS-1 is a randomized, double-blind, 2-arm multicenter Phase III trial (N=275) comparing monthly subcutaneous injections of ianalumab 300 mg against placebo over a 52-week period, focusing on clinical efficacy, safety, and tolerability⁷. NEPTUNUS-2 takes a similar approach as a randomized, double-blind, 3-arm multicenter Phase III trial (N=504) to evaluate the clinical efficacy, safety, and tolerability of ianalumab 300 mg s.c. monthly or every 3 months compared with placebo for up to 52 weeks⁸.

The primary endpoint in both trials hinged on improvements in systemic disease activity, measured by the ESSDAI (EULAR Sjögren’s syndrome disease activity index)^7,8. Patients participating in NEPTUNUS-1 and NEPTUNUS-2 are currently being offered the opportunity to continue their involvement through follow-up studies or enrollment in a long-term extension trial¹⁷.

Understanding Sjögren’s Disease

Sjögren’s disease, previously known as Sjögren’s syndrome, is a systemic, chronic autoimmune disorder marked by inflammation and tissue damage affecting the entire body⁴. Its primary target is the exocrine glands, resulting in excessive dryness, with over 90 percent of patients experiencing dry eyes and dry mouth^4,18. The disease is highly variable in its presentation; patients often suffer from dryness, fatigue, and widespread pain, while 30-40 percent also exhibit extraglandular organ involvement^5,19. These extraglandular manifestations can affect the skin, musculoskeletal system, kidneys, lungs, and other organs¹⁹. Alarmingly, the risk of lymphoma is elevated in individuals with Sjögren’s⁵.

Sjögren’s ranks among the most prevalent rheumatic autoimmune diseases, impacting roughly 0.25 percent of the population, with approximately 50 percent of cases remaining undiagnosed^20-21. It’s significantly more common in women, affecting them nine times more frequently than men⁴. B cell dysfunction plays a pivotal role in the disease’s pathology, driving an autoimmune response that fuels inflammation and tissue damage^3,4. Currently, there are no approved systemic treatments, and available therapies mainly focus on providing temporary relief from symptoms, underscoring the urgent need for effective targeted approaches³.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “investigational,” “pipeline,” “upcoming,” “intends,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for ianalumab, or regarding potential future revenues from ianalumab. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that ianalumab will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that ianalumab will be commercially successful in the future. In particular, our expectations regarding ianalumab could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

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References

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