Nipocalimab Demonstrates Sustained Disease Control in Adolescents with Generalized Myasthenia Gravis

Image Credit: Adobe Stock Images/Lila Patel

Results from the Phase II/III Vibrance-MG study found that Johnson & Johnson’s (J&J) nipocalimab demonstrated sustained disease control in adolescents between 12 and 17 years of age with generalized myasthenia gravis (gMG). According to the company, these results suggest that nipocalimab may be a promising treatment option for young patients with the autoimmune disorder.

J&J stated that nipocalimab is the first FcRn blocker to demonstrate sustained disease control in a registrational trial. These data are expected to be presented at the upcoming Myasthenia Gravis Foundation of America Scientific Session during the American Association of Neuromuscular & Electrodiagnostic Medicine annual meeting.¹

“Findings from the Vibrance-MG study underscore the potential of this investigational therapy for young individuals aged 12–17 living with gMG. Results show a significant reduction in IgG of approximately 70% in adolescents and a clinical benefit that is consistent with the Vivacity-MG3 study in adults,” said Jonathan Strober, MD, director, clinical services, child neurology, director, Muscular Dystrophy Clinic at UCSF Benioff Children’s Hospital, in a press release. “It is encouraging to see these positive results as there are currently no approved advanced treatment options for this adolescent population in the United States.”

Vibrance-MG is an on-going, open-label study aimed to determine the effect of nipocalimab in pediatric participants with gMG. In order to qualify for the trial, participants must have a positive blood test for either acetylcholine receptor (anti-AChR) muscle-specific tyrosine kinase (anti-MuSK) autoantibodies. During the study, patients will go through a screening period of up to four weeks, followed by a 24-week open-label active treatment phase during which participants receive nipocalimab intravenously every two weeks, and a long-term extension phase. The primary endpoint of the study is the effect of nipocalimab on total serum immunoglobulin G (IgG), safety and tolerability, and pharmacokinetics in pediatric participants with gMG at 24 weeks.

Results found that four out of five patients achieved minimum symptom expression by the end of their treatment phase. Nipocalimab was found to have been well tolerated over a six-month period, similar to tolerability seen in adult participants in the Vivacity-MG3 study. There were no serious adverse events (AEs) reported and no discontinuations due to a serious AE.¹

According to the Myasthenia Gravis Foundation of America, an estimated 150 to 200 out of one million people are currently living with myasthenia gravis globally. In the United States, this number is approximately 37 out of every 100,000 people. It is most common in women under 50 years of age and men over 65 years of age. On average, it is most common in people over 50 years of age. While it can affect people of all ethnic backgrounds, it is slightly more common in people of African descent. Additional research has shown that individuals of African American descent could be more likely to develop myasthenia gravis at a younger age.²

“The Vibrance-MG data add to the expanding clinical profile of nipocalimab and highlight its potential for adolescents living with gMG who are in need of new treatments,” said Sindhu Ramchandren, MD, executive medical director, neuroscience, Johnson & Johnson Innovative Medicine, in the press release. “We are committed to developing innovations for autoantibody-driven neurological diseases, like gMG, with the aim of transforming the lives of people living with these conditions.”

Earlier in the year, J&J announced the submission of applications to the FDA and EMA seeking approval for nipocalimab for the treatment of gMG.¹

References

1. Nipocalimab demonstrates sustained disease control in adolescents living with generalized myasthenia gravis in Phase 2/3 study. J&J. October 15, 2024. Accessed October 16, 2024. https://www.jnj.com/media-center/press-releases/nipocalimab-demonstrates-sustained-disease-control-in-adolescents-living-with-generalized-myasthenia-gravis-in-phase-2-3-study

2. OVERVIEW OF MG. Accessed October 16, 2024. https://myasthenia.org/understanding-mg/overview-mg/#:~:text=Globally%2C%20approximately%20150%20to%20200,million%20people%20have%20myasthenia%20gravis.&text=In%20the%20US%2C%20it%20is,100%2C000%20people%20have%20myasthenia%20gravis.