Novartis (NYSE:NVS) announced that its investigational antibody, ianalumab, combined with eltrombopag, successfully met the primary endpoint in a Phase 3 study (VAYHIT2) involving patients with primary immune thrombocytopenia (ITP).
The therapy notably prolonged the time until treatment failure, assessing how long patients maintained safe platelet counts during and after treatment.
Following the news, Novartis shares rose by 0.5% during European trading.
The Swiss pharmaceutical company said the late-stage trial focused on ITP patients previously treated with corticosteroids, demonstrating that ianalumab extended the duration of safe platelet levels beyond the active treatment phase.
ITP is a rare autoimmune disorder where the immune system attacks platelets, crucial for blood clotting.
Novartis also reported achieving a key secondary endpoint, with patients exhibiting a significantly higher rate of sustained platelet count improvements.
The firm intends to present these findings at an upcoming medical conference and incorporate the data into regulatory filings planned for 2027.
“While current treatments for ITP are generally effective in raising platelet counts, many patients require life-long treatment to maintain safe levels, which can create a lasting treatment burden,” said Adam Cuker, Professor of Medicine and Chief, Section of Hematology, University of Pennsylvania.
“The results from VAYHIT2 are encouraging, as they suggest that ianalumab may support longer periods of disease control and reduce the need for continuous treatment.”
Ianalumab is also under investigation as a potential therapy for several autoimmune diseases.
On Monday, Novartis revealed that the drug met primary endpoints in two Phase 3 trials for Sjögren’s disease.
The U.S. Food and Drug Administration has granted the drug fast track status, and Novartis plans to pursue regulatory approvals globally.
If approved, ianalumab could become the first targeted treatment available for patients with Sjögren’s disease.
“Overall, we believe that the detailed data is needed to fully assess the strength of the efficacy benefit seen,” noted Jefferies analysts in a research note.
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