Johnson & Johnson reports positive topline results for nipocalimab from a Phase 3 pivotal study in generalized myasthenia gravis (gMG) and a Phase 2 study in Sjögren’s Disease (SjD)
Johnson & Johnson announced topline results from the pivotal Phase 3 VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG) as well as the Phase 2 DAHLIAS study of nipocalimab in adults with Sjögren’s disease (SjD). Nipocalimab has demonstrated clinical effect in four autoantibody-driven diseases within the past year, including hemolytic disease of the fetus and newborn (HDFN) and rheumatoid arthritis, in addition to gMG and SjD.
In the Phase 3 VIVACITY study in gMG, nipocalimab met the primary endpoint, achieving statistically significant reduction in MG-ADLa score from baseline over weeks 22 to 24 compared with placebo (PBO). gMG is a chronic, life-long, rare, and highly debilitating autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness.
The primary endpoint was also met in the Phase 2 DAHLIAS dose-ranging study in SjD with a statistically significant reduction in clinESSDAIb score from baseline at week 24 compared with placebo (PBO). These data represent the first positive results of an investigational anti-FcRn treatment in this chronic, debilitating autoantibody disease that is without approved advanced therapies. SjD is nine times more common in women than in men, a factor of relevance to nipocalimab and the investigative treatment’s unique status among anti-FcRns, with acceptable benefit-risk demonstrated in studies in pregnant individuals thus far.
Nipocalimab was well-tolerated by participants in both studies.
“We look forward to sharing the comprehensive results of these important studies at upcoming scientific medical meetings,” said Katie Abouzahr, M.D., Vice President, Autoantibody and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson. “Johnson & Johnson is committed to addressing the immense unmet patient need in these chronic and debilitating autoantibody-driven diseases. We are the only company developing an anti-FcRn treatment in three key segments of autoantibody disease and have achieved proof of concept in each: Rare Autoantibody with gMG, Maternal Fetal Immunology with HDFN, and Prevalent Rheumatology with today’s results in SjD building on our existing data in rheumatoid arthritis.”
As next steps, Johnson & Johnson plans to present full results from the Phase 3 VIVACITY study at an upcoming scientific medical congress and engage with global regulatory authorities about bringing nipocalimab to patients living with gMG. The results from the Phase 2 DAHLIAS study support further clinical development of nipocalimab in SjD, and the full results from the study will be presented at a scientific medical congress this year.
Nipocalimab was granted Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019 and gMG in December 2021, and was granted orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in December 2023 by the U.S. Food and Drug Administration (FDA). The treatment was also granted orphan medicinal product designation by the European Medicines Agency in October 2019 for HDFN. Nipocalimab is under development and not currently approved.