Johnson & Johnson (J&J) has announced positive late-stage results for its anti-FcRn antibody in patients with generalised myasthenia gravis (gMG).
The phase 3 Vivacity-MG3 study has been assessing the efficacy and safety of nipocalimab in gMG patients as a potential treatment for the chronic condition.
Estimated to impact around 700,000 people worldwide, myasthenia gravis (MG) is a rare autoimmune disease that occurs when autoantibodies target proteins at the neuromuscular junction, affecting neuromuscular signalling and leading to the impairment or prevention of muscle contraction.
The study enrolled patients living with anti-acetylcholine receptor antibodies, anti-muscle-specific tyrosine kinase antibodies, and/or anti-low-density lipoprotein-related protein 4, which causes the immune system to mistakenly block, attack and muscle receptors in the body and accounts for around 95% of the gMG patient population.
The study achieved its primary endpoint after results presented at the European Academy of Neurology (EAN) 2024 Congress showed that nipocalimab-treated gMG patients, plus standard of care (SOC), achieved superiority over placebo plus SOC at 24 weeks, with consistent safety and tolerability with other nipocalimab studies.
In addition, secondary endpoints were met after patients treated with nipocalimab plus SOC demonstrated an improvement in strength and function of different muscle groups measured by the QMG score over weeks 22 and 24 compared to placebo plus SOC.
Furthermore, the MG-ADL scale response was significantly greater with nipocalimab plus SOC over weeks 22, 23 and 24 compared to placebo plus SOC.
“We are thrilled to [have] presented 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 foetal immunology disease area leader, J&J Innovative Medicine.
As part of its nipocalimab programme, J&J has been running several clinical trials, including phase 3 studies evaluating the antibody in Sjögren’s disease (SjD), chronic inflammatory demyelinating polyneuropathy and warm autoimmune haemolytic anaemia.
Last month, the company shared positive phase 2 results of nipocalimab in SjD, a chronic immune disease, for which the investigational antibody achieved both its primary and secondary endpoints in SjD patients versus placebo, representing the first positive results in SjD for the investigational antibody.