Johnson & Johnson reports positive phase 3 results for nipocalimab in myasthenia gravis

Johnson & Johnson (J&J) has revealed promising late-stage results for its anti-FcRn antibody, nipocalimab, in treating generalized myasthenia gravis (gMG). The Phase 3 Vivacity-MG3 study focused on evaluating the efficacy and safety of nipocalimab for this chronic autoimmune condition. Myasthenia gravis is a rare disease estimated to affect roughly 700,000 individuals worldwide. It occurs when autoantibodies attack proteins at the neuromuscular junction, disrupting neuromuscular signaling and hindering muscle contraction.

The study included participants with anti-acetylcholine receptor antibodies, anti-muscle-specific tyrosine kinase antibodies, and/or anti-low-density lipoprotein-related protein 4. These antibodies lead the immune system to mistakenly attack and block muscle receptors, affecting about 95% of the gMG patient population. The trial achieved its primary endpoint, as presented at the European Academy of Neurology (EAN) 2024 Congress, demonstrating that patients treated with nipocalimab plus standard of care (SOC) showed superior results compared to those who received a placebo plus SOC over 24 weeks. The safety and tolerability of nipocalimab were consistent with previous studies.

Additionally, secondary endpoints were successfully met. Patients treated with nipocalimab plus SOC exhibited marked improvements in muscle strength and function as measured by the QMG score over weeks 22 and 24, compared to those on placebo plus SOC. The MG-ADL scale response was significantly better in the nipocalimab-treated group over weeks 22, 23, and 24, further underscoring the treatment’s benefits.

Katie Abouzahr, Vice President and leader in autoantibody and maternal-fetal immunology at J&J Innovative Medicine, expressed excitement about the positive data presented at the EAN 2024 Annual Meeting. She emphasized the company's commitment to developing innovative treatments for diseases driven by autoantibodies.

J&J's nipocalimab program involves several clinical trials, including Phase 3 studies for the antibody's use in treating Sjögren’s disease (SjD), chronic inflammatory demyelinating polyneuropathy, and warm autoimmune hemolytic anemia. Recently, the company reported positive Phase 2 results for nipocalimab in SjD, a chronic immune disease. In these trials, the investigational antibody achieved both primary and secondary endpoints compared to placebo, marking the first positive results for nipocalimab in SjD patients.

These developments highlight Johnson & Johnson's ongoing efforts to advance treatments for autoimmune diseases, demonstrating the potential of nipocalimab to offer significant clinical benefits to patients with generalized myasthenia gravis and other autoantibody-driven conditions.