J&J’s nipocalimab racks up another win, this time in Sjögren’s disease

2024-06-17

临床结果并购临床3期临床2期上市后研究

Johnson & Johnson reported interim Phase II data for nipocalimab showing that the anti-FcRn antibody helped improve symptoms of Sjögren’s disease versus placebo. The data were shared at the European Alliance of Associations for Rheumatology (EULAR) annual meeting on Saturday.

In the DAHLIAS study, adults with Sjögren’s disease who received 15 mg/kg nipocalimab every two weeks had a more than 70% average improvement in ClinESSDAIa score versus placebo at 24 weeks. The pharma said the monoclonal antibody (mAb) also led to statistically significant and clinically meaningful reductions in disease severity compared with patients’ baseline score on the composite ClinESSDAIa scale, which assesses disease activity across 11 organ system domains.

Additionally, nipocalimab showed benefits on several key secondary endpoints, although J&J did not specify whether they were statistically significant. The results of multiple organ and physician assessments were “clinically meaningful,” and patients saw “improvement trends” on several Sjögren’s symptoms including mouth dryness, eye dryness, and vaginal dryness.

The mAb also lowered levels of IgG and disease-related autoantibodies, supporting its mechanism of action. The pharma said that nipocalimab’s safety and tolerability were consistent with other trials.

Autoantibody disease portfolio

Sjögren’s is the third disease that nipocalimab has found clinical success with since J&J gained the compound in 2020 via its $6.5-billion acquisition of Momenta Therapeutics.

Last year, the antibody met the primary endpoint of a Phase II trial of pregnant adults at high risk for severe haemolytic disease of the foetus and newborn. The pharma is also working with RallyBio to reduce the risk of foetal neonatal alloimmune thrombocytopenia.

Earlier this year, J&J said it was preparing to seek approval of nipocalimab to treat generalised myasthenia gravis after the mAb met the primary endpoint of the Phase III VIVACITY study.