Topline VIVACITY, DAHLIAS data: Nipocalimab bests placebo for myasthenia gravis, Sjögren’s
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Key takeaways:
- Nipocalimab met endpoints in a phase 3 generalized myasthenia gravis study and phase 2 Sjögren’s disease study.
- The fully human monoclonal antibody was well-tolerated in both studies.
Nipocalimab met the primary endpoint in a pivotal phase 3 trial in patients with generalized myasthenia gravis, as well as in a phase 2 study in adults with Sjögren’s disease, according to topline results released by Johnson & Johnson.
Compared with placebo, nipocalimab achieved statistically significant reductions in myasthenia gravis symptom scores at weeks 22 to 24 in the phase 3 VIVACITY trial, according to a release from Johnson & Johnson. In the phase 2 DAHLIAS trial, the drug also showed statistically significant reductions in a Sjögren’s disease severity scale, ClinESSDAI, at 24 weeks compared with placebo. The drug was well-tolerated across both studies.
“We look forward to sharing the comprehensive results of these important studies at upcoming scientific medical meetings,” Katie Abouzahr, MD, vice president and autoantibody and maternal fetal immunology disease area leader at Johnson & Johnson, said in a company press release. “Johnson & Johnson is committed to addressing the immense unmet patient need in these chronic and debilitating autoantibody-driven diseases.”
Nipocalimab is an investigational fully human monoclonal antibody designed to selectively block FcRn, reducing levels of IgG antibodies that underlie various conditions, according to the release. With these topline results, the drug has now established clinical effect in four autoantibody-driven diseases within the last year, including hemolytic disease of the fetus and newborn and rheumatoid arthritis, as well as myasthenia gravis and Sjögren’s.
Abouzahr noted Johnson & Johnson is “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 [generalized myasthenia gravis], maternal fetal immunology with [hemolytic disease of the fetus and newborn] and prevalent rheumatology with today’s results in [Sjögren’s disease] building on our existing data in rheumatoid arthritis.”
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