Johnson & Johnson Announces Positive Phase 3 Results for Nipocalimab in Generalized Myasthenia Gravis, Submits BLA
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
Johnson & Johnson recently announced its investigational antibody therapy targeting the neonatal Fc receptor (FcRn)nipocalimabInGeneralized Myasthenia GravisThe Phase 3 Vivacity-MG3 study in patients with gMG has achieved positive results.
The trial met its primary endpoint, with patients receiving nipocalimab in combination with standard of care (SOC) showing greater improvement in the gMG disease metric Activities of Daily Living (MG-ADL) score compared to those on placebo plus SOC.
Johnson & Johnson will present detailed data at the 2024 European Academy of Neurology (EAN) Congress and plans to submit the data to regulatory authorities later this year. According to the press release, the therapy, when used in combination with standard treatment in gMG antibody-positive patients (anti-AChR+, anti-MuSK+, anti-LRP4+), demonstrated superiority over placebo in improving patients' MG-ADL scores.The first FcRn blocker.
This double-blind, placebo-controlled study enrolled a broad population of patients who were anti-AChR+, anti-MuSK+, and/or anti-LRP4+, accounting for approximately 95% of the gMG patient population. Compared to baseline, patients receiving nipocalimab plus SOC treatment showed an average improvement of 4.70 points in MG-ADL scores at weeks 22, 23, and 24, significantly higher than the 3.25-point improvement observed in patients receiving placebo plus SOC treatment (P=0.002).
For gMG patients, a change of 1 to 2 points in the MG-ADL score may mean the difference between normal eating and frequent swallowing difficulties, or between shortness of breath at rest and the need for a ventilator.
In addition to achieving this primary endpoint, the trial also met key secondary endpoints:
At weeks 22 and 24, Quantitative Myasthenia Gravis (QMG) score measurements showed that nipocalimab plus SOC significantly improved strength and function across different muscle groups compared to placebo plus SOC (P<0.001).
At weeks 22, 23, and 24, nipocalimab combined with SOC showed significantly greater MG-ADL response (≥2-point improvement from baseline) compared to placebo combined with SOC (P=0.021), further highlighting the potential of nipocalimab treatment to reduce the impact on daily life for patients with gMG.
The safety and tolerability of nipocalimab in the trial were consistent with other studies. The overall incidence of adverse events, serious adverse events, and adverse events leading to discontinuation was similar to the placebo combined with SOC group.
Nipocalimab is a potential "best-in-class" antibody therapy targeting the neonatal Fc receptor. By binding to FcRn, it prevents autoantibodies taken up by monocytes and endothelial cells from being released back into the bloodstream, instead degrading them within the cells.
Existing studies have shown that it can circulate in the blood, including pathogenic autoantibodies.IgG levels decreased by more than 75%This antibody therapy has the potential to treat various autoimmune antibody-mediated immune diseases.
The FDA once granted this therapyBreakthrough Therapy Designationfor the treatment of pregnant women at high risk of severe hemolytic disease of the fetus and newborn (HDFN), and granted Fast Track designation for the treatment of HDFN, gMG, warm antibody autoimmune hemolytic anemia (wAIHA), and fetal/neonatal alloimmune thrombocytopenia (FNAIT).
This therapy was listed by the industry media Evaluate as one of the top 10 potential blockbuster therapies in development earlier this year.
Click "PharmSnap" below to follow more exciting content.
Disclaimer
The push rules of WeChat Official Accounts have changed again. If you don't tap"Views"Or not set to"Star Mark", we might just dissipate in the vast sea of literature~ Click here, don't miss out on PharmaDJ's latest news!??