Johnson & Johnson has shared positive top-line results from mid- and late-stage studies of its investigational anti-FcRn antibody in two autoimmune disorders.
The phase 3 VIVACITY trial has been evaluating nipocalimab in adults with generalised myasthenia gravis (gMG), while the phase 2 DAHLIAS study has been assessing the candidate in adults with Sjögren’s disease (SjD).
In myasthenia gravis, autoantibodies target proteins at the neuromuscular junction. This disrupts the ability of the nerves to stimulate the muscle and results in weakness.
The disease affects approximately 700,000 people worldwide, with 85% of these patients experiencing the more extensive form of the disease, gMG.
Nipocalimab met the primary endpoint in VIVACITY, achieving a statistically significant reduction in MG-ADLa score, an assessment of symptoms that affect the daily lives of patients, from baseline over weeks 22 to 24 compared with placebo.
Estimated to impact approximately 350,000 people in the US, SjD is one of the most prevalent autoantibody-driven diseases that has no approved advanced treatments.
Most patients are affected by mucosal dryness, joint pain and fatigue, and extraglandular manifestations are common and may impact multiple organ systems.
The primary endpoint was also met in DAHLIAS, with a statistically significant reduction in clinESSDAIb score from baseline at week 24 compared with placebo.
The company outlined its plans to present full results for VIVACITY at an upcoming scientific medical congress and engage with global regulatory authorities about bringing nipocalimab to patients with gMG.
It added that the data from DAHLIAS will support further clinical development of the candidate in SjD, and full results from the study will be presented at a scientific medical congress this year.
Katie Abouzahr, vice president, autoantibody and maternal fetal immunology disease area leader, J&J, said: “We look forward to sharing the comprehensive results of these important studies at upcoming scientific medical meetings.
“J&J is committed to addressing the immense unmet patient need in these chronic and debilitating autoantibody-driven diseases.”
The readouts come just a few months after J&J announced positive results from a mid-stage study of nipocalimab in rheumatoid arthritis.