J&J aims at generalized myasthenia gravis with nipocalimab

Johnson & Johnson (J&J) has recently announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for nipocalimab, a proposed treatment for generalised myasthenia gravis (gMG). This significant milestone was revealed in a press release dated August 29, which highlighted the supportive data from the VIVACITY-MG3 Phase III clinical trial (NCT04951622).

The VIVACITY-MG3 study aimed to evaluate the safety and efficacy of biweekly doses of nipocalimab in adult patients suffering from gMG. This randomised, double-blind, placebo-controlled trial enrolled 199 participants who either tested positive or negative for certain antibodies associated with gMG and had inadequate responses to standard treatments. Of these participants, 153 were antibody positive.

Earlier this year, in February, J&J reported that the Phase III trial had successfully met its primary endpoint. Specifically, this involved a statistically significant reduction in the myasthenia gravis activities of daily living scale (MG-ADL) score from baseline over a period of 22–24 weeks compared to the placebo group. Furthermore, one of the key secondary endpoints was a change in the Quantitative Myasthenia Gravis (QMG) score—a 13-item assessment conducted by physicians to measure disease severity based on impairments in body functions and structures.

The trial also included secondary endpoints related to the safety and tolerability of nipocalimab. The results indicated that the safety profile of nipocalimab was consistent with previous studies on this therapy. 

Dr. Bill Martin, Ph.D., the Global Therapeutic Area Head for Neuroscience at Johnson & Johnson Innovative Medicine, expressed optimism about the potential of nipocalimab to offer sustained disease control for individuals with generalised myasthenia gravis. He emphasized that gMG is a challenging, chronic, and life-long disease.

Generalised myasthenia gravis is a rare autoimmune disorder where autoantibodies attack proteins at the neuromuscular junction. This disrupts communication between nerves and muscles, leading to a progressive weakening of voluntary muscles.

Nipocalimab operates as an antagonist to the FcRn large subunit p51 IgG receptor. By blocking the neonatal Fc receptor (FcRn), it prevents IgG from binding to FcRn, leading to the receptor's degradation and a rapid decrease in IgG levels. This monoclonal antibody is also being studied for potential applications in treating haemolytic disease of the fetus and newborn (HDFN), rheumatoid arthritis, and Sjogren’s disease.

In February 2024, the FDA granted a breakthrough therapy designation to nipocalimab for the treatment of alloimmunised pregnant individuals at heightened risk of developing severe HDFN.

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