What is the drug thought to do in the body?

In MND, the connections between neurons and muscle cells are disrupted, which means that muscle cells do not receive signals from the neurons. This leads to muscle weakness and wasting. ARGX-119 binds to a protein on muscle cells (called MuSK) and is thought to help restore the connection between neurons and muscle cells. This suggests that muscle cells may better receive signals from the neurons. This could improve muscle strength in MND. 

Phase 2 - reALiSe

Current status: recruiting

Primary objective: To investigate the safety of ARGX-119 

The phase 2 trial is investigating the safety of ARGX-119 in people with MND, as well as looking at the effect ARGX-119 has on how well the muscles work. During the trial, three different doses of ARGX-119 will be tested. People taking part in the trial will be randomly assigned to either one of the three doses of ARGX-119 or a placebo (dummy drug). There will then be an extension period where all participants are given the same dose of ARGX-119. The trial will last for roughly 2 years. You can find out more about the trial here.

The trial is recruiting in Belgium, Canada, Denmark, France, Netherlands, and Sweden.

 

Previous Clinical Trials

Phase 1

A phase 1 trial was carried out to investigate the safety and tolerability of ARGX-119 in healthy participants. People who took part in the trial received either ARGX-119 or a placebo (dummy drug). The trial tested safety of both a single dose, and multiple doses. ARGX-119 was found to be safe and well tolerated.

Last updated: 23/05/2025