Johnson & Johnson's FcRn antibody, nipocalimab, significantly improved Sjögren’s disease activity in a phase 2 study, bringing the drugmaker a step closer to the first approved advanced treatment for the debilitating autoimmune disease.
In the phase 2 DAHLIAS study, nipocalimab demonstrated statistically significant and clinically meaningful improvement in ClinESSDAIa score — an evaluation of disease activity based on a scale that considers 11 organ system domains — versus placebo at 24 weeks. J&J shared the results in a late-breaking presentation at the EULAR 2024 Congress.
In addition to achieving the primary endpoint, the nipocalimab 15 mg/kg treatment group demonstrated clinically meaningful improvements in secondary endpoints including multiple organ assessments, physician assessments and composite tools for clinical trial endpoints. It also improved important Sjögren’s symptoms including mouth dryness, eye dryness and vaginal dryness.
J&J picked up nipocalimab through its $6.5 billion acquisition of Momenta in 2020, in a bid to strengthen its pipeline for hard-to-treat autoimmune diseases. The drug, which belongs to a promising class of drugs called FcRn antibodies, is being tested on a range of autoimmune diseases. Earlier this year, J&J announced positive results from nipocalimab's phase 3 VIVACITY study in generalized myasthenia gravis, a chronic autoimmune disorder that causes muscle weakness.
The FDA has previously granted nipocalimab Fast Track and Orphan Drug designations.
