Johnson & Johnson highlights new data, demonstrating long-term sustained disease control in adults living with generalised myasthenia gravis (gMG)

New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open label extension phase Up to 128 weeks and 180 patient years of follow-up in the open label extension phase demonstrates a safety profile consistent with the Phase 3 Vivacity-MG3 study 45% of the patients receiving steroids at open label extension baseline were able to decrease or discontinue their steroid use Additionally, the nipocalimab plus standard of care (SOC) group demonstrated four times greater odds of improving and maintaining the strength and function of different muscle groups as measured by QMG response versus placebo plus SOC in the 24-week double blind phase of the study BEERSE, BELGIUM, April 08, 2025 (GLOBE NEWSWIRE) -- – Janssen-Cilag International NV, a Johnson & Johnson company, today announced results from additional analyses of the Phase 3 Vivacity-MG3 double-blind study and the ongoing open label extensiona (OLE), evaluating the long-term efficacy and safety of nipocalimab in a broad population of antibody-positive (anti-AChR+, anti-MuSK+, anti-LRP4+) adults with generalised myasthenia gravis (gMG).1,2 Patients treated with nipocalimab plus standard of care (SOC) maintained improvements in their MG-ADLb and QMGc scores over 84 weeks with sustained reductions in total IgG.1 These data are included in a presentation (Session 7 #022) and are among 12 abstracts that Johnson & Johnson will present at the American Academy of Neurology (AAN) 2025 Congress in San Diego, California, which includes an oral presentation on QMG score improvements from the double-blind phase of the Vivacity-MG3 study. “The sustained disease control seen over 84 weeks for nipocalimab is a key result given the chronic course of generalised MG and the significant burden on people living with this condition,” said Constantine Farmakidis M.D., Associate Professor of Neurology at University of Kansas Medical Centerd. “Overall, I am encouraged by these results that show improvement in disease control as measured by the MG-ADL and QMG scores across a broad population seropositive for AChR, MuSK, or LRP4 autoantibodies.” Nipocalimab demonstrated a mean change in MG-ADL of -5.64 (p<0.001) from double-blind baseline after 60 weeks in the OLE for study participants receiving nipocalimab and SOC, and -6.01 (p<0.001) mean change for study participants who transitioned from placebo and SOC to nipocalimab and SOC.1,e In the antibody-positive population, 45% of patients receiving steroids at the OLE baseline were able to decrease or discontinue steroids at the time of this data cut by more than half of the baseline dose.1,f Among these patients, the mean dose of prednisone decreased from 23 to 10 mg per day. Nipocalimab had a consistent and tolerable safety profile throughout the OLE.1,g "Estimated to impact between 56,000 and 123,000 people across Europe, there remains a significant unmet need to expand our understanding of gMG and subsequently create additional effective therapies for patients who continue to experience the devastating symptoms of this chronic disease," said Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, Johnson & Johnson Innovative Medicine EMEA. "The promising results presented at this year's AAN congress highlight our dedication to broadening the treatment landscape for people affected by autoantibody diseases, including gMG, and could offer a renewed hope for their future care." Additional findings from the Phase 3 Vivacity-MG3 double-blind study indicate that patients treated with nipocalimab plus SOC achieved statistically significant improvements in their QMG score by -4.9 versus placebo plus SOC (p<0.001) over weeks 22 and 24.2,h Patients in the nipocalimab plus SOC treatment group were four times more likely to sustain symptom improvement at 20 weeks compared to the placebo plus SOC group, as measured by a three or greater point improvement on the QMG score.2,i Results show significantly more patients treated with nipocalimab (36.4%,) versus placebo (10.5%, p<0.001) spent greater than 75% of study duration demonstrating improvements in the QMG score.2 A reduction of more than three points in the QMG score indicates a decrease in the severity of the patient's symptoms as a result of improvements in muscle strength, allowing patients to carry out important daily activities such as swallowing and chewing.3,4 “People living with gMG around the world endure daily challenges, such as difficulties swallowing, impaired speech and muscle weakness. They deserve additional, effective treatment options that help address these challenges and provide sustained disease control and stability over time,” said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine. “These positive data underscore our commitment to helping develop potential innovative therapeutic options for patients living with autoantibody diseases, including gMG.” Editor’s notes: The open label extension interim analysis includes 60 weeks of open-label data, totalling 84 weeks for nipocalimab-treated participants, including 24 weeks from the treatment group of the double-blind phase. Some patients have follow-up data extending to 128 weeks.1MG-ADL (Myasthenia Gravis – Activities of Daily Living) provides a rapid clinical assessment of the patient's recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.3QMG (Quantitative Myasthenia Gravis) is a 13-item assessment by a clinician that quantifies MG disease severity. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity.3Dr. Constantine Farmakidis M.D. has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work.At open label extension week 60, patients who received nipocalimab plus SOC in the 24-week double-blind and open label extension phase of the trial demonstrated a mean change in MG-ADL of -5.64 [Standard error (SE): 0.621; p<0.001] compared to -6.01 for patients who received placebo plus SOC in the 24-week double-blind trial and nipocalimab in the open label extension phase [SE: 0.503, p<0.001].1In the seropositive population from the open label extension, 45% [40 patients out of the total 89 patients in the seropositive population] of patients receiving steroid at open label extension baseline were able to decrease or discontinue steroids at the time of this data cut.1The overall incidence of adverse events (AEs), serious adverse events (SAEs) and AEs leading to discontinuation were similar to that in the placebo plus SOC group. Specifically, 84% of patients (n=82) treated with nipocalimab plus SOC experienced AEs, matched by 84% (n=82) in the placebo plus SOC group. Serious AEs were reported by 9% of patients (n=9) in the nipocalimab plus SOC group compared to 14% (n=14) in the placebo plus SOC group.5Patients treated with nipocalimab demonstrated statistically significant improvement in QMG total score vs placebo over weeks 22 and 24 [least-square (LS) SE: –4.9(0.50) vs –2.0(0.50); difference= –2.81(0.710); p<.001].2Patients receiving nipocalimab were over four times more likely to sustain QMG-3 improvement for ≥16 weeks (Odds Ratio [95% CI]: 4.31[1.93, 9.66]) and for ≥20 weeks (Odds Ratio [95% CI]: 4.53[1.93, 10.62]).2 ABOUT GENERALISED 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 the neuromuscular junction and can block or disrupt normal signalling from nerves to muscles, thus impairing or preventing muscle contraction.6,7,8 The disease impacts between 56,000 and 123,000 people in Europe and an estimated 700,000 people worldwide.8,9 The disease affects both men and women and occurs across all ages, racial and ethnic groups, but most frequently starts in young women and older men.9,10,11 Roughly 50 percent of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.10,12,13 Approximately 10 to 15% of new cases of MG are diagnosed in adolescents (12 – 17 years of age).14,15,16 Among juvenile MG patients, girls are affected more often than boys with over 65% of paediatric MG cases in the EU diagnosed in girls.17,18,19 Initial disease manifestations are usually ocular, but approximately 85 percent of MG patients experience additional advancements to the disease manifestations – referred to as generalised myasthenia gravis (gMG).20,21,22 This is characterised by severe muscle weakness and difficulties in speech, and swallowing.8,11,23 Vulnerable gMG populations, such as paediatric patients, have more limited therapeutic options.24 Currently, SOC treatments for adolescents with gMG are extrapolated from adult trials.16 Other than symptomatic treatments, there are no approved FcRn blockers for adolescents with gMG in Europe.25,26,27,28,29 ABOUT THE PHASE 3 VIVACITY-MG3 STUDY The Phase 3 Vivacity-MG3 study (NCT04951622) was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable chronic condition where unmet need remains high. Antibody positive or negative adult gMG patients with insufficient response (MG-ADL ≥6) to ongoing SOC therapy were identified and 199 patients, 153 of whom were antibody positive, enrolled in the 24-week double-blind placebo-controlled trial.30,31 Randomisation was 1:1, nipocalimab plus current SOC (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC.30 Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).30 The primary endpoint of the study was mean change in MG-ADLa score from baseline over Weeks 22, 23 and 24 in antibody positive patients. A key secondary endpoint included change in QMG score. Long-term safety and efficacy were further assessed in an ongoing open label extension phase.31 ABOUT NIPOCALIMABNipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions. 32 This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Foetal diseases mediated by maternal alloantibodies and Rheumatic diseases.31,33,34,35,36,37,38,39,40 Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the foetus.41 The EMA and U.S. FDA have granted several key designations to nipocalimab including: EU EMA Orphan medicinal product designation for haemolytic disease of the foetus and newborn (HDFN) in October 2019U.S. FDA Fast Track designation HDFN and warm autoimmune haemolytic anaemia (wAIHA) in July 2019, gMG in December 2021 and foetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024 and Sjögren’s disease (SjD) in March 2025U.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 2023U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024U.S. FDA granted Priority Review in gMG in Q4 2024 ABOUT JOHNSON & JOHNSONAt 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 www.innovativemedicine.jnj.com/emea/. Follow us at www.linkedin.com/jnj-innovative-medicine-emea. Janssen-Cilag International NV and Janssen-Cilag Limited 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 materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. Janssen-Cilag International NV, 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 most recent Annual Report on Form 10-K, 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. Janssen-Cilag International NV, nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. Source: Johnson & Johnson # # # REFERENCES 1 Antozzi, C et al., Long-Term Safety and Efficacy of Nipocalimab in Generalized Myasthenia Gravis: Vivacity-MG3 Open-Label Extension Phase Results. Abstract #022 for poster presentation at 2025 American Academy of Neurology Congress. 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Johnson & Johnson highlights new data, demonstrating long-term sustained disease control in adults living with generalised myasthenia gravis (gMG)

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