Trial tests combination therapy to boost gMG relief

Argenx is advancing a clinical trial evaluating whether adding the experimental therapy empasiprubart to Vyvgart (efgartigimod alfa-fcab) can improve disease control in people with generalized myasthenia gravis (gMG) whose symptoms are only partly controlled with Vyvgart alone.

The Phase 2a clinical trial, called ADAPT-Forward 1 (NCT07284420), is expected to enroll up to 70 adults, ages 18 and older, with gMG and self-reactive antibodies against the acetylcholine receptor (AChR) protein — the most common type of gMG-driving antibody. As of June, recruitment was underway at sites across the U.S. and Europe.

Argenx, which markets Vyvgart and is developing empasiprubart, announced the trial’s advancement in a company press release.

The company also highlighted the recently expanded labels for both Vyvgart and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in the U.S., which makes them available to all adults with gMG regardless of whether they test positive for known disease-driving antibodies. The label expansions provide doctors with “a single treatment option for the broadest adult gMG patient population,” said Karen Massey, Argenx’s CEO.

Vyvgart is administered by intravenous (into-the-vein) infusion, while Vyvgart Hytrulo is available as a prefilled syringe for subcutaneous injection, which patients can self-administer after training.

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More plans for Vyvgart

Argenx said it remains on track for expanded approval of Vyvgart for ocular myasthenia gravis (oMG), a form of myasthenia gravis (MG) affecting only eye-related muscles, after positive results from the Phase 3 ADAPT OCULUS trial (NCT06558279).

The company also expects to launch an autoinjector version of the therapy, Vyvgart SC, next year, pending regulatory approval.

MG occurs when self-reactive antibodies target proteins involved in nerve-muscle communication, leading to MG symptoms such as muscle weakness and fatigue. In gMG, the disease affects muscles throughout the body.

These self-reactive antibodies belong to a class called immunoglobulin G (IgG) and most commonly target the AChR protein. Less commonly, they target the muscle-specific kinase (MuSK) protein or the low-density lipoprotein receptor-related protein 4 (LRP4).

Vyvgart and Vyvgart Hytrulo work by blocking the neonatal Fc receptor, a protein that helps stabilize antibodies in the blood. The therapies are therefore expected to lower levels of circulating IgG antibodies, including those driving gMG.

Both therapies were first approved in the U.S. for adults with gMG who tested positive for anti-AChR antibodies. Vyvgart was approved for that population in 2021, and Vyvgart Hytrulo received FDA approval in 2023.

Increased activation of the complement system, a network of proteins that forms part of the body’s immune defenses, has also been associated with AChR-related MG. This supports the use of complement-suppressing therapies in patients with self-reactive antibodies against AChR.

Empasiprubart is an experimental antibody-based therapy administered directly into the bloodstream. It is designed to block complement component 2 (C2), a key protein involved in complement system activation. Argenx is developing the therapy for several autoimmune diseases mediated by an overactive complement system.

ADAPT-Forward 1 participants will receive Vyvgart alone during a run-in period (part A). Those who experience only partial responses will move to the add-on period (part B), during which they will receive both Vyvgart and empasiprubart. Those not eligible for part B will move directly to the safety follow-up period (part C), where they will continue treatment with Vyvgart alone.

The trial’s primary goal is to evaluate the safety and tolerability of the combination therapy over nearly five months. Secondary goals include evaluating whether the combination improves disease control, which will be assessed through changes in validated measures of muscle strength and the disease’s impact on daily activities. The study is expected to conclude in early 2028.

ADAPT-Forward 1 is part of the broader ADAPT Forward platform study (NCT07294170), which is designed to evaluate new combination therapies for MG. The goal is to identify the most effective therapeutic approach that also maintains an acceptable safety profile.