"The sustained response of nipocalimab over six months among this broad myasthenia gravis population is an important finding given the chronic, unpredictable exacerbations typically seen with myasthenia gravis," said Carlo Antozzi, M.D., Neuroimmunology and Muscle Pathology Unit of the Neurological Institute Foundation C. Besta of Milan, Italy. "We are encouraged by the potential of nipocalimab to uniquely help address this gap for people living with myasthenia gravis."

The double-blind, placebo-controlled study enrolled a broad population of anti-AChR+, anti-MuSK+, and/or anti-LRP4+ patients, which account for approximately 95 percent of the gMG patient population. Patients receiving nipocalimab plus SOC improved by 4.70 points on the MG-ADL, significantly more than the 3.25 point improvement from baseline observed with placebo plus SOC over Weeks 22, 23, and 24 (P=0.002). For someone living with gMG, a 1- to 2-point change on MG-ADL may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and being on a ventilator. In addition to achieving this primary endpoint, critical secondary endpoints were also met:

• Improvement in strength and function of different muscle groups, as measured by QMG, was significantly greater with nipocalimab plus SOC compared with placebo plus SOC over Weeks 22 and 24 (P<0.001).
• MG-ADL response (≥2-point improvement from baseline) was significantly greater in nipocalimab plus SOC compared with placebo plus SOC (P=0.021) over Weeks 22, 23, and 24, further underscoring the potential of treatment with nipocalimab to mitigate the impact of gMG on a patient's day-to-day life.
• Safety and tolerability were consistent with other nipocalimab studies. The overall incidence of adverse events, serious adverse events, and adverse events leading to discontinuation was similar to that in the placebo plus current SOC group.

"We are thrilled to present yet another dataset for nipocalimab at the EAN 2024 Annual Meeting, highlighting our commitment to providing innovative treatments for autoantibody-driven diseases," said Katie Abouzahr, M.D., Vice President, Autoantibody and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine. "We are developing transformative therapies that have the potential to address significant unmet patient need.