The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SGT-003 for the treatment of Duchenne Muscular Dystrophy. The public consultation will take place from 28 January to 27 February 2026.
For each clinical trial application for the use of a genetically modified organism, the government organises a thirty-day public consultation, in accordance with the Royal Decree of 21 February 2005. As a citizen, you can give your opinion on this clinical trial application with a genetically modified medicine.
Duchenne muscular dystrophy is a rare genetic disease that mainly affects boys. From early childhood onwards, the disease causes the muscles to weaken over time. This is due to the fact that the body lacks a protein called dystrophin, which helps the muscles to retain their strength. There is no cure for the disease yet, but treatments such as corticosteroids and gene therapy can slow down its progression.
In this clinical trial, a single dose of the investigated medicine SGT-003 will be administered intravenously to boys aged seven to eleven inclusive with Duchenne muscular dystrophy. SGT-003 is a gene therapy developed to increase the expression of microdystrophin in the patients in order to strengthen the muscles and slow down or halt the damage caused by the disease. Patients will also receive steroids to reduce possible inflammatory or immune responses to the study drug.
The aim of this trial is to assess the safety and efficacy of SGT-003, compared to placebo, in patients aged seven to eleven inclusive with Duchenne muscular dystrophy.
The clinical trial will take place at the University Children’s Hospital Queen Fabiola in Brussels and at the University Hospital in Leuven.
How to give your opinion?
The public consultation runs from 28 January to 27 February 2026 inclusive. You can access the various data in the application file, as well as an online form to send your comments or ask your questions.
General information on OGM : consultations publiques | SPF Santé publique.