Novartis shares slightly up after Ianalumab meets goals in Phase 3 trial

Investing.com -- Novartis (NYSE:NVS) (SIX:NOVN) said its experimental antibody ianalumab, used in combination with eltrombopag, achieved the main goal in a phase 3 (VAYHIT2) study for patients with primary immune thrombocytopenia (ITP).

The treatment significantly extended the time to treatment failure, measuring how long patients maintained safe platelet levels during and after therapy.

Novartis shares climbed 0.5% in European trading.

The Swiss drugmaker said the late-stage trial involved ITP patients who had previously received corticosteroids, and showed that ianalumab also prolonged the duration of safe platelet counts beyond the treatment period.

ITP is a rare autoimmune condition in which the immune system destroys platelets, the blood cells needed for clotting.

A key secondary endpoint was also met, with patients showing a notably higher rate of sustained platelet count improvements, according to Novartis.

The company plans to present the results at an upcoming medical conference and include the data in regulatory submissions targeted 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 being studied as a potential therapy for multiple autoimmune diseases.

On Monday, Novartis reported that the drug also met primary endpoints in two phase 3 trials in Sjoegren’s disease.

The drug has been granted fast track status by the U.S. Food and Drug Administration, and Novartis said it will seek approval from regulators worldwide.

If cleared, ianalumab could become the first targeted therapy for patients with Sjoegren’s disease.

"Overall, we believe that the detailed data is needed to fully assess the strength of the efficacy benefit seen,” said Jefferies analysts in a note.