Johnson & Johnson has announced positive results from the Vivacity-MG3 study, a phase 3 clinical trial testing the antibody drug nipocalimab in patients with generalized myasthenia gravis (gMG).
The phase 3 study enrolled 199 patients over the course of 24 weeks. All patients received the standard of care for gMG, in addition to either nipocalimab or a placebo.
Patients who received nipocalimab showed a significant improvement in the impact of symptoms in their daily living, from 3.25 points to 4.70 points as measured using the MG-ADL scale.
“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,” stated the company in a press release.
Nipocalimab also improved the strength and function of muscles in gMG patients as compared to the placebo. The full trial results will be presented at the European Academy of Neurology (EAN) 2024 this week.
"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, from the Neuroimmunology and Muscle Pathology Unit of the Neurological Institute Foundation C. Besta of Milan.
"We are encouraged by the potential of nipocalimab to uniquely help address this gap for people living with myasthenia gravis."
Myasthenia gravis is an autoimmune disease that impairs muscle function. In about 53% of patients, the disease generalizes into gMG, causing fluctuating weakness of muscles all over the body. This can affect simple daily activities such as standing, chewing, swallowing, and even breathing.
The current standard of care for the disease can help patients manage these symptoms, but not all patients respond well to the treatments or can tolerate their side effects.
With nipocalimab, Johnson & Johnson aims to offer a better treatment alternative to gMG patients. The antibody drug targets the neonatal fragment crystallizable receptor (FcRn), which regulates the levels of immunoglobulin G (IgG) antibodies that drive the development of gMG.
Following the results of the Vivacity-MG3 trial, Johnson & Johnson is positioning nipocalimab as the first and only FcRn-blocking drug to show an improvement in daily living activities for patients with gMG.
"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, 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 needs."
