Johnson & Johnson Launches First Head-to-Head FcRn Blocker Study in Myasthenia Gravis

Johnson & Johnson查看公司主页 announced plans to initiate the first head-to-head study comparing FcRn (搜索)搜索该靶点 blockers for patients with generalized myasthenia gravis (搜索)搜索该疾病 (gMG), positioning IMAAVY查看药品详情™ (nipocalimab-aahu (搜索)搜索该药品) as the FcRn blocker of choice for appropriate gMG patients. The announcement was made at the 2025 Myasthenia Gravis (搜索)搜索该疾病 Foundation of America Scientific Session and the American Association of Neuromuscular and Electrodiagnostic Medicine Annual Meeting.

EPIC Study Design Targets Treatment Optimization

The EPIC Phase 3b study represents a randomized, open-label trial designed to compare FcRn (搜索)搜索该靶点 blockers in adults with gMG. The study will evaluate whether treatment with IMAAVY查看药品详情 provides superior disease control versus efgartigimod查看药品详情 in adults with gMG who have never received an FcRn blocker. Additionally, it includes a treatment-switch arm to assess efficacy and safety of IMAAVY in participants switching from efgartigimod to IMAAVY.

The study's key primary and secondary endpoints are change from baseline in total immunoglobulin G查看药品详情 (IgG) levels and sustained disease control measured by MG-ADL and QMG scores 8-12 weeks post-initiation of treatment, respectively.

"The EPIC study marks an important step forward in advancing care for people living with gMG," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson查看公司主页 Innovative Medicine. "By directly comparing IMAAVY查看药品详情 to another FcRn (搜索)搜索该靶点 blocker and incorporating a treatment-switch arm, EPIC will provide critical insights into how physicians can best start and transition gMG patients within this class."

Sustained Pediatric Efficacy Demonstrated

Accompanying the EPIC study announcement, Johnson & Johnson查看公司主页 presented new positive data from the Vibrance-MG Phase 2/3 long-term extension study. These data show treatment with IMAAVY查看药品详情 plus standard of care in pediatric patients aged 12 and older with gMG demonstrated sustained reductions in IgG through 72 weeks, disease control, functional improvements and long-term safety.

The Vibrance-MG analysis revealed that treatment with IMAAVY查看药品详情 led to a rapid and sustained reduction in IgG levels, with a median reduction of approximately 73% by Week 24. Improvements in both daily function and muscle strength were also observed through 72 weeks, indicating sustained disease control over time. The treatment was generally well tolerated and no new safety concerns emerged during extended follow-up.

"Pediatric patients with gMG have long been an underserved population in neuromuscular disease research," said Jonathan Strober, M.D., Director of the Pediatric Neuromuscular Program and Professor of Pediatrics and Neurology at the University of California at San Francisco. "These new Vibrance-MG LTE pediatric data are especially encouraging, showing treatment with IMAAVY查看药品详情 achieved sustained meaningful improvements in daily function and muscle strength, echoing the results seen in the Vivacity-MG3 OLE study in adults."

Differentiated Treatment Profile Across Patient Populations

The findings are consistent with positive results from the pivotal Vivacity-MG3 study and ongoing open-label extension in adult patients with gMG. Together, the data highlight the differentiated treatment profile of IMAAVY查看药品详情 across key antibody subtypes (anti-acetylcholine receptor (搜索)搜索该靶点 positive [AChR+], anti-muscle-specific tyrosine kinase (搜索)搜索该靶点 positive [MuSK+]) and the potential to provide long-term sustained disease control for the broadest population of people living with gMG.

IMAAVY查看药品详情 is currently approved by the U.S. Food and Drug Administration for adult and pediatric patients (12 years of age and older) with anti-AChR or anti-MuSK antibody positive gMG. The drug has also received approval in Brazil by ANVISA for anti-AChR, anti-MuSK or anti-LRP4 antibody positive adults and pediatric patients aged 12 and older, and in Japan by the Pharmaceuticals and Medical Devices Agency for treatment of all patients living with gMG.

Clinical Trial Details and Patient Population

The Phase 2/3 Vibrance-MG study enrolled seven participants aged 12-17 years with a diagnosis of gMG as reflected by a Myasthenia Gravis (搜索)搜索该疾病 Foundation of America Class of II through IV at screening, and an insufficient clinical response to ongoing, stable standard of care therapy. Participants must have a positive blood test for either anti-AChR or anti-MuSK autoantibodies.

The pivotal Phase 3 Vivacity-MG3 study enrolled 199 patients, 153 of whom were antibody positive, in a 24-week double-blind placebo-controlled trial. Randomization was 1:1, with 77 patients receiving nipocalimab plus current standard of care (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) and 76 patients receiving placebo plus current standard of care.

Disease Burden and Unmet Medical Need

Myasthenia gravis (搜索)搜索该疾病 is an autoantibody disease in which the immune system mistakenly makes antibodies that target proteins at the neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction. The disease impacts an estimated 700,000 people worldwide.

Approximately 85% of MG patients experience advancement to generalized myasthenia gravis (搜索)搜索该疾病, characterized by severe muscle weakness and difficulties in speech and swallowing. Approximately 100,000 individuals in the U.S. are living with gMG. Vulnerable gMG populations, such as pediatric patients, have more limited therapeutic options.

Among juvenile MG patients, girls are affected more often than boys with over 65% of pediatric MG cases in the U.S. diagnosed in girls. Approximately 10 to 15% of new cases of MG are diagnosed in pediatric patients 12-17 years of age.