Johnson & Johnson’s experimental autoimmune treatment lowered the impact of myasthenia gravis on daily life compared to placebo in antibody-positive patients in a late-stage study.
The drug is part of a closely-watched class of new autoimmune drugs that lower the level of self-attacking antibodies responsible for a range of diseases.
In the Phase 3 Vivacity-MG3 study, 153 patients with generalized myasthenia gravis received an IV infusion every two weeks of either nipocalimab or placebo on top of the standard of care, according to results shared Friday at the European Academy of Neurology’s annual meeting.
Katie AbouzahrThose who received nipocalimab saw roughly a 1.5-point improvement more than placebo on a scale that measures the impact of myasthenia gravis on daily functions. J&J’s autoantibody drug head Katie Abouzahr said that “is maybe the difference between normal eating versus frequent choking on food, or shortness of breath on rest to being on a ventilator.”
The candidate is a major part of J&J’s R&D portfolio, and the company is hoping for the first approval for nipocalimab in generalized myasthenia gravis. J&J is developing nipocalimab across over 10 indications, according to Abouzahr, and the company projects that it can reach over $5 billion in revenue.
At weeks 22 to 24, 68.8% of trial participants were responders — meaning they saw at least a two-point improvement on the daily function scale — compared to 52.6% of those who received placebo.
The patients who received nipocalimab on top of standard of care saw a 4.7-point improvement on the daily living scale over weeks 22 to 24, while those who received placebo saw a 3.25-point improvement during the same period. The p-value was 0.002.
Eleven percent of patients in the nipocalimab arm experienced peripheral edema or swelling.
Nipocalimab is an antibody that targets the neonatal Fc receptor, or FcRn, leading to the destruction of disease-causing IgG antibodies, which are prevalent in a range of autoimmune conditions.
J&J said it plans to file nipocalimab in generalized myasthenia gravis for regulatory approval by the end of the year. If approved, it would compete with argenx’s Vyvgart, which last year generated $1.2 billion across both its IV and injectable versions.
J&J highlighted that its trial covered three antibody-positive groups, including AChR+, MuSK+, and LRP4+. Vyvgart is only approved for acetylcholine receptor (AChR) antibody-positive patients.
Others developing treatments in the space include Biohaven and Immunovant, both of which have disclosed healthy volunteer data.