MDA 2026: Trial testing Imaavy versus Vyvgart recruiting adults with gMG
Eligible participants must test positive for antibodies against the AChR protein
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A new trial dudbed EPIC is comparing Imaavy and Vyvgart for generalized myasthenia gravis (gMG).
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Both drugs block FcRn and target antibodies that cause muscle weakness and fatigue in gMG.
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The trial will assess efficacy and safety, and inform treatment switching for anti-AChR antibody-positive adults.
sJohnson & Johnson (J&J) has launched a Phase 3b clinical trial to compare the efficacy of two approved treatments for generalized myasthenia gravis (gMG).
The trial, dubbed EPIC (NCT07217587), is specifically testing J&J’s Imaavy (nipocalimab) against Argenx’s Vyvgart (efgartigimod) in adults with gMG who test positive for antibodies against the acetylcholine receptor (AChR) protein, the most common MG-driving antibodies.
Currently enrolling at sites in the U.S. and Israel, the study will also collect data on gMG patients who switch from Vyvgart to Imaavy.
EPIC’s design was recently presented in a poster at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, running March 8-11 in Orlando and virtually. The poster is titled “Efficacy and Safety of Nipocalimab vs Efgartigimod in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching (EPIC).”
Imaavy, Vyvgart both designed to block activity of key protein
Myasthenia gravis (MG) is an autoimmune disease caused by antibodies that interfere with signaling between nerve and muscle cells, leading to such symptoms as muscle weakness and fatigue.
Imaavy and Vyvgart are both designed to block the activity of neonatal Fc receptor (FcRn), a protein that normally helps prevent circulating antibodies from being broken down. By suppressing FcRn, these therapies aim to accelerate the breakdown of antibodies, including MG-driving antibodies.
In the U.S., the two therapies are approved for adults with gMG who test positive for anti-AChR antibodies. Imaavy is also authorized for adolescents ages 12 and older, as well as for individuals who are positive for the second-most common MG-driving antibody, which targets the muscle-specific kinase protein.
Although both medications work in similar ways and are given by infusion into the bloodstream, they differ in structure and have notably different administration schedules. Imaavy infusions are given every other week, whereas Vyvgart is given in cycles of four weekly infusions, with additional cycles repeated as needed.
“Currently, there are no trials directly comparing efficacy of [Imaavy vs. Vyvgart] and no data to inform switch strategies from [Imaavy] to [Vyvgart],” the researchers wrote.
Patients initially taking Vyvgart may be eligible to switch to Imaavy
With this in mind, J&J launched the EPIC trial. Up to 115 adults with gMG, ages 18 to 74, who are positive for antibodies targeting AChR are expected to be enrolled.
These criteria were meant to ensure that participants are eligible for either therapy and to closely match the populations in each large-scale trial that supported the approval of each therapy.
EPIC’s head-to-head portion will include about 80 gMG patients who have not previously received FcRn-targeting therapies, are on stable treatment that is not adequately controlling their disease, or have discontinued treatment due to intolerance or lack of efficacy.
These participants will be randomly assigned to receive either Imaavy for 12 weeks (about three months) or Vyvgart for four weeks (about a month). The study will be open-label, meaning patients will know which therapy they are receiving.
EPIC is the first [appropriately- esigned] trial comparing advanced treatments for patients with gMG and is designed to provide critical insights to inform clinical decisions when initiating or switching in the FcRn-targeting class.
The trial’s goals are to compare antibody levels and scores on two validated measures of disease severity — Myasthenia Gravis Activities of Daily Living and Quantitative Myasthenia Gravis — at weeks eight, 10, and 12. Safety will also be assessed.
“The EPIC trial addresses whether [Imaavy] provides superior efficacy to [Vyvgart] in the latter part of [Vyvgart] cycles that cover most dosing patterns utilized in clinical practice,” the researchers wrote.
After the initial four-week treatment cycle, participants on Vyvgart may be eligible to enter the trial’s switch portion, in which they will receive Imaavy for 12 weeks and be monitored for safety and MG severity. This part of the trial will also enroll at least 35 additional patients who have completed at least one four-week cycle of Vyvgart treatment.
“EPIC is the first [appropriately designed] trial comparing advanced treatments for patients with gMG and is designed to provide critical insights to inform clinical decisions when initiating or switching in the FcRn-targeting class,” the researchers wrote.
The trial is expected to provide top-line data in late 2027 and to finish by the end of 2028.
Note: The Myasthenia Gravis News team is providing live coverage of the 2026 MDA Clinical & Scientific Conference March 8-11 in Orlando, Florida. Go here to see the latest stories from the conference.
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