An experimental Novartis drug has succeeded against a tough-to-treat autoimmune condition, boosting the outlook for a multibillion-dollar acquisition the Swiss pharmaceutical company made last year.
According to Novartis, the drug, called ianalumab, met its main goal in two Phase 3 studies in Sjögren’s syndrome, a chronic and progressive immune disease. Novartis didn’t provide specifics, but said Monday that treatment with ianalumab led to statistically significant improvements in disease activity compared to a placebo in each trial, as measured by a widely used index evaluating symptoms. The drug was also “well tolerated” and demonstrated “a favorable safety profile,” the company said in a statement.
Novartis will share the findings at an upcoming medical meeting and submit them to global health regulators.
The results position Novartis to extract some value out of its 2024 acquisition of German biotechnology company MorphoSys. Novartis bought MorphoSys for $2.9 billion last February, chiefly for a myelofibrosis drug called pelabresib. Initially, Novartis intended to submit pelabresib to regulators last year, but the company later determined that it needed to obtain more data to support approval. CEO Vas Narasimhan has said doing so could take “at least until 2027,” and the company, as a result, has already wrote down the value of the deal.
But Novartis also acquired other drug prospects in the MorphoSys deal. Among them was ianalumab, which Novartis had collaborated with MorphoSys on prior to the acquisition.
Ianalumab is an antibody the companies have been investigating against a variety of autoimmune conditions, such as Sjögren’s, lupus and immune thrombocytopenia, that are driven by the malfunctioning of B cells. The drug targets B cells in two ways, marking them for destruction by other immune cells and blocking a receptor called BAFF-R that’s crucial to their survival.
Novartis said during an earnings call last month that ianalumab wasn’t effective enough against a different autoimmune condition, hidradenitis suppurativa, to warrant further research. But that result didn’t “really shift our conviction” on the drug’s potential elsewhere, Narasimhan told investors. The first of those readouts was in Sjögren’s, an immune disease characterized by a variety of symptoms including dry eyes and mouth, joint pain and fatigue.
Multiple available treatments can manage the symptoms of Sjögren’s. But none can change its course, in part because several once-promising medicines have failed in testing for one reason or another. Novartis’ results position the company to bring the first “targeted treatment” to market, if approved by regulators, the company said.
"Sjögren’s disease is a serious, progressive, systemic autoimmune disease, often unrecognized or misdiagnosed with a significant detrimental impact to quality of life, with very limited treatment options and an established unmet need,” said Shreeram Aradhye, Novartis’ head of development and chief medical officer, in the company’s statement. The studies “mark a significant milestone.”
