J& J Announces Positive Phase 3 Trial Results for Nipocalimab in gMG

Johnson & Johnson (NYSE: JNJ) has announced promising outcomes from its Phase 3 Vivacity-MG study, evaluating Nipocalimab in patients with generalized myasthenia gravis (gMG). The study demonstrated that patients treated with Nipocalimab, in combination with standard of care (SOC), experienced significantly greater improvements compared to those receiving placebo plus SOC. These findings were presented at the European Academy of Neurology (EAN) 2024 Congress and are poised for regulatory submissions later this year.

Key Findings from the Vivacity-MG Study

The double-blind, placebo-controlled Phase 3 trial included a broad population of gMG patients, comprising those with anti-acetylcholine receptor (AChR), anti-muscle-specific tyrosine kinase (MuSK), and anti-low-density lipoprotein receptor-related protein 4 (LRP4) antibodies, which together represent about 95% of the gMG patient demographic.

Primary Endpoint:

  • MG-ADL Score Improvement: Patients receiving Nipocalimab plus SOC showed an improvement of 4.70 points on the MG-ADL (Myasthenia Gravis Activities of Daily Living) score over 24 weeks, compared to a 3.25-point improvement in the placebo group (P=0.002). This represents a significant difference of 1.45 points, underscoring the clinical impact of Nipocalimab​.

Secondary Endpoints:

  • Muscle Strength and Function: The Quantitative Myasthenia Gravis (QMG) score, which measures muscle strength and function, improved significantly more in the Nipocalimab group compared to the placebo group (P<0.001)​​.
  • MG-ADL Response: A ≥2-point improvement from baseline in MG-ADL scores was observed significantly more in patients treated with Nipocalimab plus SOC than those receiving placebo plus SOC (P=0.021), highlighting Nipocalimab’s potential to enhance daily living activities for gMG patients​.

Expert Insights

Dr. Carlo Antozzi, from the Neuroimmunology and Muscle Pathology Unit of the Neurological Institute Foundation C. Besta in Milan, Italy, emphasized the significance of these results:

“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. We are encouraged by the potential of Nipocalimab to uniquely help address this gap for people living with myasthenia gravis”​​.

Future Steps and Regulatory Submissions

Johnson & Johnson plans to submit these Phase 3 data to regulatory authorities later this year.

Dr. Katie Abouzahr, Vice President of Autoantibody and Maternal Fetal Immunology Disease Area at Johnson & Johnson, remarked:

“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. We are developing transformative therapies that have the potential to address significant unmet patient needs”​.

About Generalized Myasthenia Gravis (gMG)

gMG is an autoimmune disease characterized by fluctuating skeletal muscle weakness due to autoantibodies targeting proteins at the neuromuscular junction, impairing muscle contraction. It affects approximately 700,000 people worldwide and can lead to severe symptoms such as limb weakness, drooping eyelids, double vision, and difficulties with chewing, swallowing, speech, and breathing​.

About Nipocalimab

Nipocalimab is an investigational monoclonal antibody designed to block the neonatal Fc receptor (FcRn), reducing levels of circulating immunoglobulin G (IgG) while preserving overall immune function. It aims to treat conditions driven by autoantibodies and alloantibodies across various medical fields, including rare autoantibody diseases, maternal-fetal medicine, and prevalent rheumatological conditions​​.

For more detailed information on the study and Nipocalimab, visit the Johnson & Johnson website or consult the latest presentation at the EAN 2024 Congress.

Original Source: HELSINKI, June 28, 2024 /PRNewswire/ — Johnson & Johnson (NYSEJNJ) Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class for broadest population of myasthenia gravis patients

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