Nipocalimab eases disease severity in adults with gMG: Phase 3 trial

Top-line results from VIVACITY study to be detailed at upcoming meeting

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by Steve Bryson, PhD |

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Nipocalimab, an investigational therapy for people with generalized myasthenia gravis (gMG), significantly eased disease severity compared with a placebo, according to top-line data from a pivotal Phase 3 clinical trial.

Johnson & Johnson, the therapy’s developer, also plans to engage with regulatory authorities worldwide to present complete data from the VIVACITY study (NCT04951622), according to a company press release. The trial is considered pivotal because its findings are required to support nipocalimab’s possible approval by regulators.

Full VIVACITY results will be shared at an upcoming scientific meeting, the company added, and data from an earlier Phase 2 study likely also will be given to regulators.

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Nipocalimab aims to treat gMG by degrading self-reactive IgG antibodies

MG results when self-reactive antibodies wrongly attack and disrupt the communication between nerves and muscles. gMG is a severe disease type, characterized by widespread muscle weakness and fatigue.

Nipocalimab is an infusion treatment designed to block the interaction between FcRn, a protein receptor that normally helps to protect antibodies circulating in the bloodstream, and immunoglobulin G (IgG) antibodies, which include the self-reactive antibodies that drive MG. (It was initially developed by Momenta Pharmaceuticals, which was acquired by Johnson & Johnson in 2020.)

By blocking this interaction, the therapy is expected to ease disease severity by promoting the degradation of IgG autoantibodies.

The international Phase 2 Vivacity-MG study (NCT03772587), which ended in 2020, evaluated nipocalimab’s safety, tolerability, efficacy, and pharmacological properties in 68 adults with hard-to-treat, moderate-to-severe gMG.

Across all doses, more participants treated with nipocalimab had a significant and durable reduction in MG Activities of Daily Living (MG-ADL) scores for at least four weeks, compared with those given a placebo (51.9% vs. 15.4%). Responses occurred quickly, and treatment-associated IgG reductions directly linked with symptom relief. Of note, MG-ADL is a validated measure of MG severity, in which lower scores indicate a lessening in disease severity.

VIVACITY, a global Phase 3 trial, is further evaluating nipocalimab’s safety and efficacy in about 198 adults with gMG. Participants are given intravenous infusions of nipocalimab or a placebo every two weeks for up to 24 weeks, or about six months. The trial, expected to conclude fully in 2026, is still recruiting patients at sites across North America, Europe, East Asia, and Australia.

Its primary goal was to assess changes in MG-ADL scores occurring from the study’s start (baseline) up to week 24.

Meeting this primary objective, top-line VIVACITY data showed nipocalimab’s use significantly reduced disease severity compared with a placebo, as demonstrated in lower average MG-ADL scores. The company did not detail score changes in its release.

The therapy also was reported to be well tolerated by patients.

Therapy’s potential also seen in trials of other autoantibody-driven diseases

Nipocalimab also has shown clinical benefits in three other autoantibody-driven diseases within the past year: rheumatoid arthritis, Sjögren’s syndrome, and hemolytic disease of the fetus and newborn (HDFN), according to Johnson & Johnson.

Newly released data from the Phase 2 DAHLIAS study (NCT04968912) showed that nipocalimab significantly reduced disease severity in adults with Sjögren’s over the course of 24 weeks. According to Johnson & Johnson, these are the first positive findings of an experimental therapy targeting FcRn in Sjögren’s, a chronic autoimmune disorder for which there are no targeted treatments.

“We look forward to sharing the comprehensive results of these important studies at upcoming scientific medical meetings,” said Katie Abouzahr, MD, vice president, autoantibody and maternal fetal immunology disease area leader at Johnson & Johnson. “Johnson & Johnson is committed to addressing the immense unmet patient need in these chronic and debilitating autoantibody-driven diseases.”