Novartis Unveils Promising Data for Potential First Targeted Sjögren's Treatment

Novartis has presented late-breaking Phase III data for ianalumab, a dual-targeted antibody showing significant promise in reducing disease activity and patient burden in Sjögren's disease. The results, unveiled at the American College of Rheumatology Convergence congress, mark a potential breakthrough in the treatment of this common autoimmune condition.

Ianalumab: A Dual Mechanism of Action

Ianalumab, named after the Roman god Janus, employs a unique dual mechanism of action as a B cell depleting antibody that also targets the BAFF receptor. Shreeram Aradhye, president of development and chief medical officer at Novartis, explained, "The core premise was that this dual mechanism should allow us to more effectively deliver tissue level B cell depletion in difficult to treat autoimmune diseases."

The Phase III NEPTUNUS-1 and NEPTUNUS-2 trials demonstrated that ianalumab elicited a greater reduction in disease activity by week 16, with improvements sustained through week 52 compared to placebo. These improvements were measured using the EULAR Sjögren's Syndrome Disease Activity Index. Notably, patients treated with ianalumab also experienced consistent improvements in dryness, pain, and fatigue—hallmark symptoms of Sjögren's disease.

Addressing an Unmet Medical Need

Sjögren's disease, affecting an estimated 3 to 4 million people in the U.S., is characterized by Aradhye as a "difficult, heterogeneous disorder" with varied manifestations. Currently, only symptomatic treatments are available, leaving a significant unmet medical need for targeted therapies.

Novartis plans to submit the Phase III results to global regulators early next year, potentially paving the way for the first targeted treatment for Sjögren's disease. Aradhye noted that based on discussions with rheumatologists and patient representatives, there is an expectation that people will want to try a targeted drug with a reasonably safe profile if approved.

Expanding Immunology Portfolio and Future Prospects

The success of ianalumab in Sjögren's disease is part of Novartis' broader focus on immunology. The company is also exploring ianalumab's potential in other indications, including systemic lupus erythematosus (SLE), lupus nephritis, and systemic sclerosis. Phase III trials for lupus indications are expected to read out around 2027.

Additionally, Novartis is leveraging its expertise in cell therapy to explore CAR T applications in autoimmune diseases. The company will present biomarker data from a Phase I/II study of its autologous CD-19 CAR T therapy, rapcabtagene autoleucel (YTB323), in SLE at the ACR congress.

As Novartis continues to expand its immunology portfolio, these developments represent significant steps forward in addressing complex autoimmune conditions and potentially improving the lives of millions of patients worldwide.