J&J’s Nipocalimab Demonstrates Positive Phase III and Phase II Results in Autoimmune Disorders

Johnson & Johnson (J&J) has announced promising results from two clinical trials for their monoclonal antibody, Nipocalimab, targeting autoimmune disorders. These results include a Phase III study for generalized myasthenia gravis (gMG) and a Phase II study for Sjögren's disease (SjD).

Key highlights:

1. gMG Study: The study, known as vivacity, showed that Nipocalimab significantly reduced the myasthenia gravis-activities of daily living (MG-ADL) score compared to a placebo over 22 to 24 weeks.
2. SjD Study: The Phase II study, named DAHLIAS, exhibited a statistically significant reduction in the clinESSDAI score at week 24, indicating the drug's effectiveness compared to the placebo.

Nipocalimab was acquired by J&J in a $6.5 billion all-cash deal with Momenta Therapeutics in 2020. The drug has demonstrated clinical efficacy across multiple autoantibody-driven diseases, including hard-to-treat rheumatoid arthritis and the rare Hemolytic Disease of the Fetus and Newborn (HDFN).

J&J plans to present detailed results from both studies at upcoming medical meetings and engage with regulators regarding the approval path for Nipocalimab in gMG.

Nipocalimab is considered a potential blockbuster that could generate billions of dollars in annual sales. The FDA has not yet approved therapies for HDFN or disease-modifying treatments for Sjögren's' like Sjögren's's (SjD).

The Phase II scale-up of rheumatoid arthritis and the Phase III open-label study for HDFN, where the majority of patients on Nipocalimab experienced a live birth at or after 32 weeks of gestation without the need for an infusion of red blood cells during pregnancy, also showed positive results.

Nipocalimab is among the most advanced in a new class of therapies that target FcRn (fetal nucleus, indicating its potential as a possible blockbuster therapy.