MorphoSys takeover delivers phase 3 win for Novartis

A drug for autoimmune disease Sjögren's syndrome, picked up by Novartis when it bought MorphoSys for $2.9 billion last year, has hit the target in a pair of phase 3 trials.

Ianalumab (VAY736), a drug targeting BLyS/BAFF, achieved a statistically significant reduction in disease activity in patients with Sjögren's, a condition that affects millions of people worldwide and causes dryness in mucosal surfaces like the eyes and mouth, as well as organ damage and an increase in the risk of life-threatening cancers.

This is the first time that a drug has been shown to address the underlying pathology of Sjögren's in phase 3 trials, according to Novartis, which reckons ianalumab has the potential to become the first and only targeted treatment approved for the disease. It plans to move ahead with regulatory filings for the antibody on the back of the results.

In the NEPTUNUS-1 and NEPTUNUS-2 studies, ianalumab achieved the primary objective of improving disease activity, measured by a reduction in the EULAR Sjögren's syndrome disease activity index (ESSDAI), compared to placebo. Full details of the study will be presented at a forthcoming medical conference.

"Sjögren's disease is a serious, progressive, systemic autoimmune disease, often unrecognised 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' chief medical officer.

"These phase 3 studies mark a significant milestone," he added. "We look forward to engaging with health authorities to discuss these findings in the near future."

Ianalumab is one of a clutch of potential therapies that could help to transform the management of Sjögren's disease, which currently relies on artificial tears and saliva substitutes, medications to stimulate tear and saliva production, painkillers, and immunosuppressant drugs if symptoms are severe.

One near-term rival is Johnson & Johnson's FcRn inhibitor nipocalimab, which started a phase 3 programme last December. Meanwhile, Argenx is also running late-stage studies of its FcRn inhibitor Vyvgart (efgartigimod alfa), as is RemeGen with BLyS/BAFF and APRIL-targeting drug telitacicept.

Novartis was developing anti-CD40 antibody iscalimab for Sjogren's, but abandoned the programme earlier this year after phase 2 results proved to be a disappointment. Last year, Sanofi also stopped developing its similarly acting antibody frexalimab in the disease after mid-stage trials failed to meet expectations.

Image by Engin Akyurt from Pixabay