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Nipocalimab demonstrates sustained disease control in adolescents living with generalised myasthenia gravis in the Phase 2/3 study

October 15, 2024 – Clinical Trials, Drug Discovery, Pharmaceutical – Johnson & Johnson, Johnson & Johnson Innovative Medicine, clinical trials, generalised myasthenia gravis

First FcRn blocker to demonstrate sustained disease control over 24 weeks in antibody positive adolescents aged 12 – 17 years, broadening the population in which nipocalimab has been studied

15 October 2024 — Beerse, Belgium — Janssen-Cilag International NV, a Johnson & Johnson company, today announced positive results from the Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChRa positive adolescents (aged 12 – 17 years) living with generalised myasthenia gravis (gMG). Study participants who were treated with nipocalimab plus standard of care (SOC) achieved sustained disease control as measured by the primary endpoint of immunoglobulin G (IgG) reduction from baseline over 24 weeks, and secondary endpoints of improvement in MG-ADLb and QMGc scores. These Phase 2/3 data will be featured in an oral presentation (Abstract #MG100) at the Myasthenia Gravis Foundation of America (MGFA) Scientific Session during the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting, taking place in Savannah, Georgia from October 15 to October 18, where Johnson & Johnson will present 25 abstracts.

“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 percent in adolescents and a clinical benefit that is consistent with the Vivacity-MG3 study in adults,” said Jonathan Strober, Director of the Pediatric Neuromuscular Clinic sponsored in part by the Muscular Dystrophy Association at UCSF Benioff Children’s Hospital. “It is encouraging to see these positive results as there are currently limited approved advanced treatment options for this adolescent population in Europe.”

About 10 percent of new cases of myasthenia gravis are diagnosed in adolescents (12 – 17 years of age) and the severity of gMG in paediatric patients is heightened with 43 percent having experienced over five hospitalisations in their lifetime, 46 percent having at least one intensive care unit stay and 68 percent having periods of exacerbated disease.

Treatment with nipocalimab plus SOC met the study’s primary endpoint of reduction in total serum IgG (-69 percent), and the two secondary endpoints of MG-ADL and QMG, which are measures of disease activity. Four of five patients achieved minimum symptom expression (MG-ADL score 0-1) by the end of their treatment phase. Nipocalimab was well-tolerated over the six-month period, similar to tolerability seen in adult participants in the Vivacity-MG3 study. There were no serious adverse events and no discontinuations due to an adverse event.

Presented for the first time, these open-label Phase 2/3 results in adolescents are consistent with findings from the pivotal study of nipocalimab in adult patients with gMG. Nipocalimab when added to SOC is the first FcRn blocker to demonstrate sustained disease control in a registrational trial as measured by improvement in MG-ADL over placebo plus SOC over a period of six months of consistent dosing (Q2 week) among adults living with gMG.

“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, M.D., Executive Medical Director, Neuroscience, Johnson & Johnson Innovative Medicine. “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 this year, Johnson & Johnson, announced the submission of applications to the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) seeking approval for nipocalimab for the treatment of gMG.

“At J&J, we are innovating with purpose to lead where medicine is going in the autoantibody diseases space,” said Ludovic de Beaucoudrey, Ph.D., Senior Director, Therapeutic Area Lead, Immunology, Janssen-Cilag Limited, a company of Johnson & Johnson. “We are encouraged by bringing the potential clinical benefit of nipocalimab in adolescents living with generalised myasthenia gravis, and with these promising results, we are one step closer to bringing this innovative treatment option to young people living with this debilitating condition.”

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at www.innovativemedicine.jnj.com/emea/.