Oral session, featuring nipocalimab results in adolescents living with gMG represents first FcRn blocker data to be presented focusing on this population with high unmet medical need
Oral and poster sessions to include multiple new analyses from the Phase 3 Vivacity-MG3 pivotal study in adults living with gMG that reinforce the potential of nipocalimab to deliver sustained disease control
Additional presentations to highlight patient real-world data, insights and lived experience with gMG
SPRING HOUSE, Pa. (October 3, 2024) – Johnson & Johnson (NYSE: JNJ) announced today that 25 abstracts featuring robust research to understand unmet needs in generalized myasthenia gravis (gMG) and evaluate nipocalimab as a potential advanced treatment option will be presented at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Session from October 15-18, 2024 in Savannah, Georgia.
16 abstracts will be shared at the MGFA Scientific Session, including three oral presentations about nipocalimab, an investigational product:
- Positive results from the Phase 2/3 Vibrance-MG study of nipocalimab in adolescents living with gMG. (Abstract #MG100)
- New analyses from the Phase 3 Vivacity-MG3 study of nipocalimab in antibody-positive (anti-AChR+, anti-MuSK+ or, anti-LRP4+) adults reporting early improvement in clinical symptoms with nipocalimab after treatment initiation (e.g., 1 week), and sustained response over 8, 16, and 24 weeks. (Abstract #MG102)
- Assessment of nipocalimab as an immunoselective investigational therapy through the analysis of antibody levels detected in the blood after receiving certain vaccines, highlighting the potential ability to maintain a protective immune response even after reduction of IgG autoantibodies is observed. (Abstract #MG111)
The presentations also include real-world data on the patient experience and challenges associated with gMG, including negative impact of the disease on speaking, swallowing and breathing as well as factors associated with exacerbations of gMG, including mental health and challenges in managing the condition during pregnancy.
“The data to be presented at AANEM and MGFA highlight the unmet need that continues to exist for the broad population of people living with gMG as well as the clinical and biological profile of nipocalimab,” said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader at Johnson & Johnson Innovative Medicine. “We remain committed to deepening our understanding of gMG and of nipocalimab in the potential treatment of this rare disease as we progress the study of this investigational FcRn therapy through a comprehensive clinical program.”
The full list of accepted Johnson & Johnson abstracts is below.
Data presentation highlights: MGFA Special Session – October 15
*Indicates also being presented as a poster at AANEM (Oct. 16-18)
Presenter/Presentation Time (ET) Poster Number |
Abstract Name |
|---|---|
Oral Session |
|
Jonathan Strober, M.D. 10:24-10:31am* (MG100) |
Safety and effectiveness of nipocalimab in adolescent participants in the open label Phase 2/3 Vibrance-MG clinical study |
Tuan Vu, M.D. 10:38-10:45am* (MG102) |
Efficacy and safety of nipocalimab in patients with generalized myasthenia gravis: topline results from the double-blind, placebo-controlled, randomized Phase 3 Vivacity-MG3 study |
Sheng Gao, BS 11:32-11:39am* (MG111) |
Post-hoc analysis of clinically relevant anti-vaccine antibodies in participants treated with nipocalimab |
Poster Session |
|
MG784* |
Assessing the suitability of the NeuroQoL Fatigue to evaluate fatigue in patients living with gMG |
MG195 |
A randomized, open-label study on the effect of nipocalimab on vaccine responses in healthy participants |
MG21 |
Disease burden in patients with generalized myasthenia gravis |
MG162* |
Leveraging AI to characterize mental health experiences throughout the myasthenia gravis diagnosis journey |
MG173 |
Uncontrolled myasthenia gravis can contribute to additional stress burden and adverse mental health experiences |
MG184 |
Sentiment analysis of digital conversations related to myasthenia gravis by race/ethnicity |
MG5* |
Factors influencing exacerbations and crises in gMG: findings from a claims database study |
MG6 |
Impact of race and social determinants of health on exacerbations in generalized myasthenia gravis |
MG93* |
Perinatal treatment patterns in myasthenia gravis |
MG94* |
Adverse pregnancy outcomes in myasthenia gravis: A retrospective cohort study in a US health insurance claims database |
MG3 |
Partnering with patients and caregivers to guide the development of impactful study engagement tools in a generalized myasthenia gravis real world study |
MG24 |
Long-Term Safety And Efficacy Of Nipocalimab In Generalized Myasthenia Gravis: Vivacity-Mg3 Open-Label Interim Analysis |
MG25 |
Symptom severity assessment using MG-ADL items and domains in a 24-week, Phase 3 study (Vivacity) of nipocalimab in gMG |
Data presentation highlights: AANEM-only – October 16-18 |
|
Poster Number |
Abstract Name |
|---|---|
Poster Session |
|
MyReg RWE (#143) |
Treatment outcomes among patients with generalized myasthenia gravis in the Czech Republic: results from MYasthenia gravis REGistry (MyReg) |
MG-REST Canada (#256) |
Interim results for myasthenia gravis-resource utilization, epidemiology, survival & treatment patterns (MG-REST) study in Ontario, Canada |
About Generalized Myasthenia Gravis (gMG)
Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK] or anti-low density lipoprotein-related protein 4 [LRP4]), which target proteins at neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.1,2 The disease impacts an estimated 700,000 people worldwide.1 The disease affects both men and women and occurs across all ages, racial and ethnic groups, but most frequently impacts young women and older men.3 Roughly 50 percent of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.4,5,6 Approximately 10 to 15 percent of new cases of MG are diagnosed in adolescents (12 – 17 years of age).7,8,9 Among juvenile MG patients, girls are affected more often than boys with over 65 percent of pediatric MG cases in the US diagnosed in girls.10,11,12
Initial disease manifestations are usually ocular but in 85 percent or more13,14 cases, the disease generalizes (gMG), which is characterized by fluctuating weakness of the skeletal muscles leading to symptoms like limb weakness, drooping eyelids, double vision and difficulties with chewing, swallowing, speech, and breathing.1,15,16 Approximately 100,000 individuals in the U.S. are living with gMG.17 Although gMG may be managed with current SOC therapies, new therapies are needed for those who may not respond well enough to or tolerate these options. There are no approved FcRn blockers that may address the root cause of the disease for adolescents with gMG.9
About Nipocalimab
Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, while preserving immune function without causing broad immunosuppression. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Prevalent Rheumatology.18,19,20,21,22,23,24,25,26 Blockade of IgG binding to FcRn in the placenta is also believed to prevent transplacental transfer of maternal alloantibodies to the fetus.27,28
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:
- U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024
- U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023
- U.S. FDA Breakthrough Therapy designation for HDFN in February 2024
- EU EMA Orphan medicinal product designation for HDFN in October 2019
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com.
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Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Media contact:
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Investor contact:
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